The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies): - Degenerative spondylolisthesis with objective evidence of neurologic impairment; - Trauma (i.e., fracture or dislocation); - Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); - Tumor; - Stenosis; - Failed previous fusion (pseudarthrosis) The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
Device Story
Temporary, single-use spinal fixation system; components include pedicle screws (mono-axial/poly-axial), rods, crosslinks, and connectors. Surgeon builds rigid construct to stabilize thoracic, lumbar, and sacral spine. Attached via screw fixation to vertebral body. Used in clinical/OR settings by orthopedic surgeons. Provides internal fixation to facilitate spinal fusion; benefits patient by immobilizing unstable segments, correcting deformities, and supporting bone healing. Implants removed after solid fusion achieved.
Clinical Evidence
Bench testing only. Evaluated via static/dynamic compression bending (ASTM F1717) and static axial/torsion grip testing (ASTM F1798). Biocompatibility evaluated per ISO 10993-1. Results demonstrated mechanical properties comparable to or exceeding predicate devices.
Indicated for skeletally mature patients requiring posterior non-cervical spine (T1-S2/Illium) immobilization as an adjunct to fusion. Treats degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion. Also indicated for severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft (L3-sacrum fixation).
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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August 30, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthopeasia Co., Ltd % Joseph Azary Regulatory Consultant Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K240180
Trade/Device Name: Orthopeasia Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 1, 2024 Received: August 1, 2024
Dear Joseph Azary:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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approvals in the device master record (21 CFR 820.181).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows a digital signature for Eileen Cadel. The signature includes the name "Eileen Cadel - S" in a large font on the left side of the image. On the right side, it states that the signature is digitally signed by Eileen Cadel, with a date and time stamp of 2024.08.30 14:41:21 -04'00'.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
Submission Number (if known)
K240180
Device Name
Orthopeasia Spinal Fixation System
Indications for Use (Describe)
The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
- Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- Trauma (i.e., fracture or dislocation);
- Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);
- Tumor;
- Stenosis;
- Failed previous fusion (pseudarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
r-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary Traditional 510(k) Orthopeasia Spinal Fixation System
#### SUBMITTER/510(K) HOLDER 1.
Orthopeasia Co., Ltd. 33/15 Moo 10, Theparak Road Bangpla, Bangplee, Samutprakarn TH-10540 Thailand
## Submission Contact
Joseph Azary Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, CT 06484
Email: jazary@erols.com Alternate Email: jazary@aztechregulatory.com
Telephone: (203) 242-6670
Date Prepared: August 29, 2024
Reason for 510(k): New device / Initial Submission
#### 2. DEVICE NAME
| Proprietary Name: | Orthopeasia Spinal Fixation System |
|----------------------------|-----------------------------------------|
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Common Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Regulation: | 21 CFR 888.3070 |
| Product Code: | NKB |
| Classification: | Class 2 |
| Medical Specialty (Panel): | Orthopedic |
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| Type of Predicate | Device Name | Manufacturer | 510(k)<br>Number |
|-------------------------|------------------------------------|-------------------|-----------------------------|
| | | | Product Code |
| Primary | Firebird Spinal<br>Fixation System | Orthofix, Inc | K130932<br>NKB, KWP,<br>OSH |
| Additional<br>Predicate | LOPSA IS Spinal<br>Fixation System | Corentec Co., Ltd | K200267<br>NKB, KWQ |
#### 3. PREDICATE DEVICES
#### 4. DEVICE DESCRIPTION
The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.
The Orthopeasia Spinal Fixation System is this submission comprises of the following components,
A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with:
- a. Monoaxial screw diameters from 5.5mm to 8.5mm
- b. Polyaxial screw diameters from 5.5mm to 8.5mm
- c. Monoaxial length range from 20mm to 55mm
- d. Polyaxial length range from 20mm to 100mm
- e. Made up of titanium alloy (ASTM F136).
- B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537)
- C. Crosslinks and connectors made up of titanium alloy (ASTM F136).
#### న. INDICATIONS FOR USE
The Orthopeasia Spinal Fixation System is intended to provide immobilization and stabilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:
{5}------------------------------------------------
- 트 Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- . Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- Trauma (i.e., fracture or dislocation);
- ' Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis):
- Tumor;
- 트 Stenosis;
- I Failed previous fusion (pseudoarthrosis)
The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5 - S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.
#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject device has similar indications, materials, components, sterility status, single use, dimensions and instrumentation as compared to predicate devices. The differences include some minor differences in the wording of the indications for use, the additional predicate can be used for pediatric, and the subject devices are offered in longer lengths. Based on the testing to consensus standards (including worst case) and comparison to predicate devices, we conclude the differences do not impact safety or efficacy of the devices.
The minor differences include that primary predicate (Firebird) has a subset that can be used for pediatric patients, whereas the Firebird and Orthopeasia systems are for skeletally mature patients.
The technological design features of the subject Orthopeasia Spinal Fixation System is substantially equivalent to the predicate devices. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent.
{6}------------------------------------------------
#### 7. PERFORMANCE TESTING
The Orthopeasia devices were subjected to a variety of testing including:
- -Biocompatibility Evaluation per 10993-1 (refer to Section ાં ર ISO Biocompatibility)
- Sterilization Validation (refer to Section 14 Sterilization and Shelf Life) -
In addition to the above referenced testing, the device was subjected to the testing outlined below.
| Test Name | Test Description and<br>Objective | Test Results / Summary |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Static and<br>Dynamic<br>Compression<br>Bending | Testing to ASTM F1717 to<br>determine the mechanical<br>properties of spinal implant<br>assemblies in a vertebrectomy<br>model under static and<br>dynamic axial compression. | The results were above the range reached by implants of<br>the additional predicate (lumbar polyaxial device). |
| Static axial and<br>torsion grip test | Testing to ASTM F1798 | The results were within the range reached by predicate<br>devices. Therefore, the results passed. |
## 8. CONCLUSION
The information presented supports substantial equivalence of the Orthopeasia Spinal Fixation System to the predicate device based on similarities in intended use, design, principles of operation and performance specifications.
The company concluded that based on testing, compliance to consensus standards, the indications for use, technological characteristics, and comparison to predicate devices, Orthopeasia Co., Ltd. found that the subject device is substantially equivalent to the predicate devices.
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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.
