The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: - i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; - ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment; - iii) Fracture; - Dislocation; iv) - Scoliosis: v) - vi) Kyphosis; - vii) Spinal tumor; and - viii) Previous failed fusion (pseudarthrosis). The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.
Device Story
Transverse stabilizing device; increases strength of pedicle screw instrumentation constructs in posterior spinal fusion. Implant features multiple lengths; adjustable angulation; proprietary dual locking mechanism for cross-link/rod connection. Used in hospitals/surgery sites by orthopedic surgeons. Provides immobilization/stabilization of spinal segments during fusion process. Benefits patient by enhancing construct stability in treatment of spinal deformities/instabilities.
Clinical Evidence
Bench testing only. Dynamic compression bending testing performed per ASTM F1717-14. Two constructs tested at 175N (7.0Nm) at 5Hz; both successfully completed 5,000,000 cycles.
Technological Characteristics
Transverse spinal stabilizer; Ti-6Al-4V alloy (ASTM F136); dual locking mechanism; multiple lengths; adjustable angulation. Sterilization via moist heat (ISO 17665-1).
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's name and national scope.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2016
Innovasis, Inc. Mr. Marshall McCarty Director OA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K162143
Trade/Device Name: FixxSure® X-Link Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: September 16, 2016 Received: September 19, 2016
Dear Mr. McCarty:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
# Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162143
Device Name FixxSure® X-Link
#### Indications for Use (Describe)
The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:
- i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
- ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- iii) Fracture;
- Dislocation; iv)
- Scoliosis: v)
- vi) Kyphosis;
- vii) Spinal tumor; and
- viii) Previous failed fusion (pseudarthrosis).
The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*
*Talon® is a Registered Trademark of Amendia, Inc.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in all caps. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font.
# 510(k) Summary Report
FixxSure® X-Link (Updated 15 September 2016)
- Company: Innovasis, Inc. 614 E. 3900 South Salt Lake City, UT 84107
- Contact: Marshall C. McCarty Phone: (801) 261-2236 mmccarty@innovasis.com
FixxSure® X-Link Trade Name:
Common Name: Pedicle Screw System X-Link
- Classification: 21 CFR 888.3070 Pedicle screw spinal system Class II Product Code: MNH, MNI Review Panel: Orthopedic-Posterior Spine Devices Brand (PSDB)
Purpose of Submission: Change in intended use.
### Applicable Standards:
| Acronym | Standard / Authorities / Bodies |
|----------|------------------------------------------------------------------------|
| AAMI | American Association of Medical Instrumentation |
| ASTM | American Society for Testing and Materials |
| CFR | Code of Federal Regulations |
| FDA CDRH | Food and Drug Administration Center for Device and Radiological Health |
| ISO | International Organization for Standardization |
| Standard Citation | Title |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Standards and Guidance - Medical Devices | |
| ANSI BS EN ISO<br>13485: 2012 | Medical Devices - Quality Management Systems - Requirements for<br>Regulatory Purposes |
| 21 CFR Part 801 | U.S. FDA, Code of Federal Regulations, Labeling |
| 21 CFR Part 820 | U.S. FDA, Code of Federal Regulations, Quality System Regulation |
| FDA CDRH<br>Guidance | Guidance for Industry and FDA Staff: Spinal Systems 510(k)s |
| FDA CDRH<br>Guidance | Guidance for Industry and for FDA Staff: Use of Standards in Substantial<br>Equivalence Determinations |
| ASTM F136-13 | Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium<br>ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS<br>R56401) |
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Image /page/4/Picture/1 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in a bold, sans-serif font. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern.
FixxSure® X-Link
| Standard Citation | Title |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F983-86<br>(R2009) | Standard Practice for Permanent Marking of Orthopaedic Implant<br>Components |
| ASTM F1582-98<br>(R2011) | Standard Terminology Relating to Spinal Implants |
| ASTM F1717-15 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy<br>Model |
| Risk Analysis and Design Control: Standards and Guidance | |
| AAMI ANSI ISO<br>14971:2007/(R)2010 | (Corrected 4 October 2007) Medical Devices - Application of Risk<br>Management to Medical Devices |
| FDA CDRH<br>Guidance | Design Control Guidance for Medical Device Manufacturers |
| Biocompatibility Evaluations: Standards and Guidance | |
| ANSI/AAMI/ISO<br>10993-1:2009 & Cor<br>1:2010 | Biological Evaluation of Medical Devices |
| Sterilization Methods: Standards and Guidance | |
| AAMI TIR12:2010 | Design, Testing and Labeling Reusable Medical Devices for Re-<br>processing in Health Care Facilities |
| ANSI/AAMI<br>ST79:2010 &<br>A1:2010 | Comprehensive Guide to Steam Sterilization and Sterility Assurance in<br>Health Care Facilities |
| ISO 17665-1: 2006 | Sterilization of Healthcare Products - Moist Heat - Part 1 Requirements<br>for the Development, Validation and Routine Control of a Sterilization<br>Process for Medical Devices |
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Image /page/5/Picture/1 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in all caps. Below the main logo, there is a tagline that reads "INNOVATE / INVOLVE / INVENT" in a smaller font size. The logo has a modern and sleek design.
- Primary Predicate: K081331 SpineWorks FixxSure® X-Link This predicate has not been subject to a design-related recall.
- Additional Predicates: K140238 Innovasis Excella III-D® Spinal System K032739 SeaSpine Crossbar
- Device Description: The SpineWorks FixxSure X-Link is a transverse stabilizing device utilized to increase the strength of a pedicle screw instrumentation construct in posterior spinal fusion. The FixxSure implant comes in multiple lengths and has the capability of being manipulated into various planes of anqulation. The FixxSure implant has a proprietary dual locking mechanism allowing maximum cross-Link/rod connection while maintaining ease of insertion/use.
- Performance Data: (Non-clinical)—Testing was performed in accordance with ASTM F1717-14, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." Two Excella II pedicle screw constructs with the FixSure X-Link were tested per F1717 for dynamic compression bending at 175N (7.0Nm) and 5Hz. Both constructs successfully completed 5,000,000 cycles.
- Materials: The components in this submission are fabricated from Ti-6AI-4V alloy, conforming to ASTM F136, which is known to have good biocompatibility.
- Intended Use: The Innovasis SpineWorks brand FixxSure X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal seqments during the fusion process.
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
Indications for Use: The SpineWorks FixxSure X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:
- Severe spondylolisthesis (grades 3 and 4) of the L5-S1 i) vertebra;
- ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- iii) Fracture:
- Dislocation: iv)
- Scoliosis; v)
- vi) Kyphosis;
- Spinal tumor; and vii)
- viiii) Previous failed fusion (pseudarthrosis).
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Image /page/6/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern.
The SpineWorks FixxSure X-Link can also be used with the Talon® Pedicle Screw System. *
## Basis for Substantial Equivalence:
The SpineWorks FixxSure X-Link was cleared by FDA on July 23, 2008 under K081331. Innovasis acquired this product from SpineWorks, LLC in 2014, and has legal ownership of the brand name (SpineWorks) and the device cleared under K081331.
The Innovasis Excella III-D Spinal Deformity System was cleared by FDA on May 7, 2014 under K140238. This system included the Universal X-Link, which was a design upgrade of the cross link cleared October 7, 2010 under K102248. The primary difference in these two implants is the ability of the Universal X-Link to work with both 6.0 and 5.5mm rods.
The technological characteristics were found to be substantially equivalent in terms of design, sizes, materials (biocompatibility profile and processing), and mechanical strength.
- Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
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.
Where do you find a device's intended use without opening the PDF?
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.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
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.
6. Collections
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.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
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.
What can you do from the regulations tree view?
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.
