The Porous Coated Comprehensive® Fracture Stems are indicated for: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis. 3) Revision where other devices or treatments have failed. 4) Correction offunctional deformity. 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral/glenoid components with a porous coated surface coating are indicated for either cemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation). The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads. The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem. The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads. The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-Modular™ Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System. When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.
Device Story
Porous Coated Comprehensive® Fracture Stems are orthopedic implants for shoulder joint replacement; device consists of cast Co-Cr-Mo humeral stem with proximal body featuring four fins; three fins include suture holes for bone attachment; proximal body includes porous plasma-spray coating for biological fixation; reverse taper design allows compatibility with Bio-Modular® or Versa-Dial® humeral heads and Comprehensive® Reverse Shoulder components; intended for use by orthopedic surgeons in clinical settings; device provides structural support and joint articulation to restore function in patients with degenerative disease or fractures; clinical benefit derived from improved fixation and modularity for complex shoulder reconstruction.
Clinical Evidence
No clinical data submitted. Substantial equivalence determined based on non-clinical bench testing, including median fatigue testing.
Technological Characteristics
Material: Cast Co-Cr-Mo. Surface: Porous plasma-spray coating. Design: Humeral stem with 4-fin proximal body and reverse taper. Fixation: Cemented or uncemented biological fixation. Compatibility: Modular with Bio-Modular/Versa-Dial humeral heads and reverse shoulder components.
Indications for Use
Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or cuff arthropathy requiring revision or where other treatments are inadequate.
Regulatory Classification
Identification
A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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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 eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Biomet Manufacturing Corporation Mr. Brian Kincaid Global Project Manager, Regulatory Affairs - SET 56 East Bell Drive Warsaw. Indiana 46582
Re: K140652
Trade/Device Name: Porous Coated Comprehensive® Fracture Stems Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, MBF, HSD Dated: April 4, 2014 Received: April 8, 2014
Dear Mr. Kincaid:
This letter corrects our substantially equivalent letter of July 3, 2014.
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 Part 801); medical device reporting (reporting of medical
{1}------------------------------------------------
Page 2 - Mr. Brian Kincaid
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
# Lori A. Wiggins -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) K140652
Device Name Porous Coated Comprehensive® Fracture Stems
#### Indications for Use (Describe)
The Porous Coated Comprehensive® Fracture Stems are indicated for:
- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis.
- 3) Revision where other devices or treatments have failed.
- 4) Correction offunctional deformity.
5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads.
The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem.
The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-ModularTM Humeral Heads and glenoid components and Versa-DialTM Humeral Heads.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the ComprehensiveTM Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-ModularTM Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System.
When a humeral stem and/or Versa-DialTM Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# JUL 0 3 2014
## Section 5 - 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | | |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell Drive<br>Warsaw, IN 46582 | |
| Phone number | (574) 267-6639 | |
| Fax number | (574) 372-1718 | |
| Establishment<br>Registration Number | 1825034 | |
| Name of contact<br>person | Brian Kincaid | |
| -Date prepared | March 7, 2014 | |
| Name of device | | |
| Trade or proprietary name | Porous Coated Comprehensive® Fracture Stems | |
| Common or usual name | Shoulder Replacement Prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint<br>metal/polymer non-<br>constrained cemented<br>prosthesis | 21 CFR 888.3650 | KWT |
| Shoulder joint,<br>metal/polymer, semi-<br>constrained, cemented<br>prosthesis | 21 CRF 888.3660 | KWS |
| Shoulder joint -<br>metal/polymer/metal non-<br>constrained or semi-<br>constrained porous-coated<br>uncemented prosthesis | 21 CFR 888.3670 | MBF |
| Shoulder joint humeral<br>(hemi-shoulder) metallic<br>uncemented prosthesis | 21 CFR 888.3690 | HSD |
| Classification panel | Orthopedics | |
| Legally marketed device(s) to<br>which equivalence is claimed | Comprehensive Humeral Fracture Stems (K023063) | |
| | Comprehensive Primary Shoulder Stems (K060692) | |
| | Kirschner® Neer-III™ Modular Proximal Humerus | |
| | (K874643) | |
| Reason for 510(k) submission | Line extension | |
| Device description | Biomet's Porous Coated Comprehensive® Fracture Stems | |
| | consist of a humeral stem comprised of cast Co-Cr-Mo. | |
| | The Proximal body of the stem contains 4 fins, three of | |
| | which include suture holes to facilitate multiple | |
| | attachment sites for the bone. The proximal body also | |
| | contains a porous plasma-spray coating, which will allow | |
Porous Coated Comprehensive® Fracture Stems Traditional 510(k) Biomet Manufacturing Corp.
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## K140652 (page 2/3)
.
. ・ ·
> l .
・
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| | for optimum fixation of the stem in the proximal humerus. The humeral stem contains a reverse taper which allows for the use of either a Bio-Modular® humeral head or glenoid component, a Versa-Dial® humeral head, or the Comprehensive® Reverse Shoulder humeral components. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Porous Coated Comprehensive® Fracture Stems are indicated for: |
| | 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. |
| | 2) Rheumatoid arthritis. |
| | 3) Revision where other devices or treatments have failed. |
| | 4) Correction of functional deformity. |
| | 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. |
| | 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. |
| | Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) |
| | Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation). |
| | The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads. |
| | The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem. |
| | The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ |
Porous Coated Comprehensive® Fracture Stems Traditional 510(k)
Biomet Manufacturing Corp.
.
·
ﻟﺴﺮ
{6}------------------------------------------------
## K140652 (page 3/3)
)
| | Humeral Heads. |
|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio- Modular Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System. |
| | When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user |
| | should refer to the package insert (01-50-0903) |
| | continued with the reverse shoulder components for |
| | additional information, including alternate indications. |
Summary of The Technological Characteristics Compared to the Predicate
The new device is identical or similar in design, materials, and intended use as the
predicate devices. Design differences have been demonstrated to not affect safety or
effectiveness or raise new issues of safety or effectiveness.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS
Median Fatigue Test
SUMMARY OF CLINICAL-TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical data submitted
**CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA**
No clinical data was necessary for a determination of substantial equivalence. The results of
testing indicated the devices did not raise any new safety and efficacy issues and were found
to be substantially equivalent to the predicate devices.
・
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•
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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.
