The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of: Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Post-traumatic osteoarthritis, Fractures. Rheumatoid arthritis. The main indications for the implantation of an AGILON® hemi shoulder prosthesis are: Multifragmental comminuted fractures of the humeral head. 3- and 4-Fragment-fractures of the proximal humerus, Head-splitting fractures. Dislocated head-splitting fractures, Humeral head depression with more than 40% of joint surface depressed, Interlocking chronic dislocation with deep HILL-SACHS lesion, Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening), Posttraumatic humeral head necrosis, Omarthrosis. AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases. The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are: Rotator cuff tear arthropathy, Chronic trauma shoulder, Decentering of the humeral head after implantation of a humeral head prosthesis. Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement. In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows: From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint. The device is intended for adults. The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
Device Story
AGILON XO Shoulder System is a modular shoulder prosthesis line extension; adds all-polyethylene cemented glenoid components to existing system. Components mate with previously cleared implantcast shoulder hardware. Used by orthopedic surgeons in clinical settings for total or hemi-shoulder arthroplasty. Surgeon selects specific implant configuration based on patient age, weight, bone quality, and joint deformity. Provides structural replacement for damaged or diseased shoulder joints; restores joint function and stability. System supports conversion between hemi, anatomic total, and inverse configurations during revision surgery.
Clinical Evidence
Bench testing only. Evaluations included dynamic evaluation of glenoid loosening or disassociation per ASTM F2028-17 and range of motion (ROM) assessment. Testing performed on worst-case components demonstrated performance equivalent to predicate devices.
Technological Characteristics
Modular shoulder prosthesis system. Stems designed for cementless fixation; glenoids designed for cemented fixation. Materials include polyethylene for glenoid components. Testing conducted per ASTM F2028-17 for glenoid loosening/disassociation. System is non-constrained, metal/polymer cemented prosthesis.
Indications for Use
Indicated for adults requiring total or hemi shoulder replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), post-traumatic osteoarthritis, fractures, or rheumatoid arthritis. Specific indications for hemi-arthroplasty include humeral head fractures, head-splitting fractures, humeral head depression, chronic dislocation, and post-traumatic necrosis. CTA heads indicated for stable rotator cuff tear arthropathy with intact fornix humeri and subscapularis tendon. Inverse prosthesis indicated for rotator cuff tear arthropathy, chronic trauma, and humeral head decentering. Requires anatomically suitable joint and functional deltoid muscle.
Regulatory Classification
Identification
A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Special Controls
*Classification.* Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
{0}------------------------------------------------
# 510(K) SUMMARY
| Manufacturer: | implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner<br>Head of Regulatory Affairs<br>implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany<br>Phone: +49 4161 744 135<br>Fax: +49 4161 744 200<br>Email: j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurl<br>MCRA, LLC<br>803 7th Street NW, Floor 3<br>Washington, DC 20001<br>Phone: 202.552.5797<br>dmcgurl@mcra.com |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and<br>Common Name: | Class II |
| Classification: | 21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,<br>Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System<br>is indicated for use for total or hemi shoulder replacement<br>in cases of: |
{1}------------------------------------------------
- Non- inflammatory degenerative joint disease including ● osteoarthritis and avascular necrosis,
- Post-traumatic osteoarthritis,
- Fractures.
- Rheumatoid arthritis. ●
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- . Multifragmental comminuted fractures of the humeral head.
- 3- and 4-Fragment-fractures of the proximal humerus, ●
- Head-splitting fractures. ●
- Dislocated head-splitting fractures, ●
- . Humeral head depression with more than 40% of joint surface depressed,
- Interlocking chronic dislocation with deep HILL-SACHS lesion,
- . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
- Posttraumatic humeral head necrosis, ●
- . Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- Rotator cuff tear arthropathy,
- Chronic trauma shoulder,
- Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with
{2}------------------------------------------------
a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
- . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- From Inverse (Reverse) Total Shoulder Arthroplasty to ● Hemi Shoulder Arthroplasty as salvage procedure
- . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- From Anatomic Total Shoulder Arthroplasty to Inverse ● (Reverse) Total Shoulder Arthroplasty
- From Anatomic Total Shoulder Arthroplasty to Hemi ● CTA Shoulder Arthroplasty
The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
- Device Description: The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared
{3}------------------------------------------------
implantcast shoulder components to make a complete prosthesis.
| Predicate Device: | - Fx Solutions Humeris Shoulder (K163669) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Device: | - AGILON XO Shoulder Replacement System (K191433) |
| Substantial<br>Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid<br>Cemented components are substantially equivalent to the<br>glenoids of the legally marketed predicate device system, the<br>Fx Solutions Humeris Shoulder, with respect to design and<br>intended use. Additionally, the AGILON XO Glenoids<br>Cemented components are substantially equivalent to<br>components of the AGILON XO Shoulder Replacement<br>System reference device cleared in K191433. |
| Performance Testing: | All necessary testing has been performed for the "worst-case"<br>components of the AGILON XO Shoulder System to assure<br>substantial equivalence to its predicate and to demonstrate the |
subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
- . Range of Motion (ROM) Evaluation
- The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.
{4}------------------------------------------------
### Indications for Use
510(k) Number (if known) K222482
Device Name AGILON XO Shoulder System
The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of.
- · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- · Post-traumatic osteoarthritis,
- · Fractures,
- · Rheumatoid arthritis.
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- · Multifragmental comminuted fractures of the humeral head,
- · 3- and 4-Fragment-fractures of the proximal humerus,
- · Head-splitting fractures,
- · Dislocated head-splitting fractures,
- · Humeral head depression with more than 40% of joint surface depressed,
- · Interlocking chronic dislocation with deep HILL-SACHS lesion,
- · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
- · Posttraumatic humeral head necrosis,
- · Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- · Rotator cuff tear arthropathy,
- · Chronic trauma shoulder,
- · Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
- · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
- · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
- · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
{5}------------------------------------------------
· From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{6}------------------------------------------------
# 510(K) SUMMARY
| Manufacturer: | implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner<br>Head of Regulatory Affairs<br>implantcast GmbH<br>Lüneburger Schanze 26<br>21614 Buxtehude<br>Germany<br>Phone: +49 4161 744 135<br>Fax: +49 4161 744 200<br>Email: j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurl<br>MCRA, LLC<br>803 7th Street NW, Floor 3<br>Washington, DC 20001<br>Phone: 202.552.5797<br>dmcgurl@mcra.com |
| Date Prepared: | August 17, 2022 |
| Device Trade Name: | AGILON XO Shoulder System |
| Device Class and<br>Common Name:<br>Classification: | Class II<br>21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,<br>Metal/Polymer Cemented |
| Product Codes: | KWT, PHX, HSD |
| Indications for Use: | The AGILON® XO Shoulder Replacement System<br>is indicated for use for total or hemi shoulder replacement<br>in cases of: |
{7}------------------------------------------------
- Non- inflammatory degenerative joint disease including ● osteoarthritis and avascular necrosis,
- Post-traumatic osteoarthritis,
- Fractures.
- Rheumatoid arthritis. ●
The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
- . Multifragmental comminuted fractures of the humeral head.
- 3- and 4-Fragment-fractures of the proximal humerus, ●
- Head-splitting fractures. ●
- Dislocated head-splitting fractures, ●
- . Humeral head depression with more than 40% of joint surface depressed,
- Interlocking chronic dislocation with deep HILL-SACHS lesion,
- . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
- Posttraumatic humeral head necrosis, ●
- . Omarthrosis.
AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases.
The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
- Rotator cuff tear arthropathy,
- Chronic trauma shoulder,
- Decentering of the humeral head after implantation of a humeral head prosthesis.
Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with
{8}------------------------------------------------
a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
- . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty
- From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
- From Inverse (Reverse) Total Shoulder Arthroplasty to ● Hemi Shoulder Arthroplasty as salvage procedure
- . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
- From Anatomic Total Shoulder Arthroplasty to Inverse ● (Reverse) Total Shoulder Arthroplasty
- From Anatomic Total Shoulder Arthroplasty to Hemi ● CTA Shoulder Arthroplasty
The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
The device is intended for adults.
The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.
- Device Description: The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared
{9}------------------------------------------------
implantcast shoulder components to make a complete prosthesis.
| Predicate Device: | Fx Solutions Humeris Shoulder (K163669) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Device: | AGILON XO Shoulder Replacement System (K191433) |
| Substantial<br>Equivalence: | The AGILON XO Shoulder System AGILON® XO Glenoid<br>Cemented components are substantially equivalent to the<br>glenoids of the legally marketed predicate device system, the<br>Fx Solutions Humeris Shoulder, with respect to design and<br>intended use. Additionally, the AGILON XO Glenoids<br>Cemented components are substantially equivalent to<br>components of the AGILON XO Shoulder Replacement<br>System reference device cleared in K191433. |
| Performance Testing: | All necessary testing has been performed for the "worst-case”<br>components of the AGILON XO Shoulder System to assure<br>substantial equivalence to its predicate and to demonstrate the |
subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
- . Range of Motion (ROM) Evaluation
- The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.
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Part 1 — Search, results, and everyday workflows 16 min
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
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Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
