The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.
Device Story
Modular reverse shoulder prosthesis; replaces glenohumeral joint in patients with rotator cuff deficiency. System components: humeral stem, reverse body, UHMWPE insert, glenoid baseplate, glenosphere, and bone screws. Humeral stem (cemented/uncemented) and body (cementless) implanted into humerus; glenoid baseplate (cementless) fixed to scapula via central compression screw and peripheral screws. Glenosphere attaches to baseplate via taper lock. Device restores joint stability and function in patients with severe arthropathy or failed prior arthroplasty. Used by orthopedic surgeons in clinical/OR settings. Benefits include improved shoulder function and pain relief through mechanical reconstruction of the glenohumeral joint.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including taper disassembly force, fatigue evaluation, rotational resistance, screw pullout strength, and range of motion testing.
Indicated for patients with grossly deficient rotator cuff joint with severe arthropathy or previous failed joint replacement with grossly deficient rotator cuff. Requires anatomically/structurally suited joint and functional deltoid muscle.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Ascension Orthopedics, Incorporated Ms. Susan Walton Director, Regulatory Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754
Re: K130050
Trade/Device Name: Integra TITAN Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: May 14, 2013 Received: May 17, 2013
Dear Ms. Walton:
This letter corrects our substantially equivalent letter of June 18, 2013.
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. Iisting 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
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Page 2 - Ms. Susan Walton
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/ResourcesforYou/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
## Indications for Use Statement
KISOOSO 510(K) Number:
Device Name: Integra TITAN Reverse Shoulder System
Indications for Use:
The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The glenoid base plate is intended for cementless application with the addition of screws for fixation.
The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE-DO NOT-WRITE BELOW THIS LINE-CONTINUE-ON-ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Harren Frank Start States<br>TE-Hanley<br>13<br>19-4 12-2 1-2 | |
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| 24153<br>84 15<br>- - - -<br>પં<br>Divis<br>Admin<br>ું જુ<br>vices<br>13<br>Personal Production September 2017 | |
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| | 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------|
| SPONSOR | Ascension Orthopedics, Inc.<br>A wholly owned division of Integra LifeSciences, Inc.<br>8700 Cameron Road<br>Austin, TX 78754-3832 | | |
| 510(k) CONTACT: | Susan Walton<br>susan.walton@integralife.com<br>Phone: (512) 836-5001 x1591<br>FAX (512) 836-6933 | | |
| DATE PREPARED: | January 5, 2013 | | |
| TRADE NAME: | Integra TITAN Reverse Shoulder System | | |
| COMMON NAME: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | | |
| CLASSIFICATION: | 21 CFR 888.3660 – Shoulder joint metal/polymer semi-constrained cemented prosthesis | | |
| PRODUCT CODE: | KWS | | |
| PANEL: | Orthopedic | | |
| PREDICATE<br>DEVICES: | K081016 | Promos Reverse Shoulder System | Smith & Nephew Inc. |
| | K113523<br>K110598 | SMR Reverse Shoulder System | Lima Corporate S.P.A. |
| | K120174<br>K062250 | Delta Xtend Reverse Shoulder System | DePuy, Inc. |
| | K041066 | Encore Reverse Shoulder Prosthesis | DIO Surgical/Encore Medical |
| construct. The humeral components consist of humeral stems, varying heights of reverse<br>bodies, and humeral poly liners. The poly liners are available in varying thicknesses and<br>constraints to achieve stability and offset of the glenohumeral joint. The variable length<br>reverse bodies and proximally-filling shape are designed to accommodate the natural humeral<br>geometry, providing stable fixation as well as proximal bone loading. The glenoid components<br>are composed of a baseplate secured by a central compression screw and 4 peripheral screws,<br>two of which can be locked. A glenosphere is attached to the baseplate via taper lock.<br>Glenospheres are available in varying offsets and lateralizations. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint<br>with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator<br>cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected<br>implants and a functional deltoid muscle is necessary to use the device.<br>The glenoid base plate is intended for cementless application with the addition of screws for<br>fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body<br>component is intended for cementless use. |
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| SUMMARY OF<br>TECHNOLOGICAL<br>CHARACTERISTICS | Feature/ Characteristic | TITAN Reverse Shoulder System<br>(Subject Device) |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant Design | • Modular design comprised of humeral stem, reverse<br>body, polyethylene insert, glenoid base, eccentric and<br>concentric glenosphere, glenoids baseplate and bone<br>screw. |
| | Components - Humeral Stem | |
| | Materials | • Cobalt Chromium alloy - cemented<br>• Titanium alloy - press fit |
| | Sizes | 90mm Length Press Fit Stem<br>• 11 diameters (6-16mm)<br>90mm Length Cemented Stem<br>• 5 diameters (6-14mm)<br>Revision Stems<br>• Two lengths - 125 and 165mm<br>• 4 diameters (8-14mm) |
| | Components - Reverse Body | |
| | Materials | • Titanium alloy with porous coating |
| | Sizes | 142.5° inclination angle available in 3 body heights |
| | Components - Insert | |
| | Materials | • UHMWPE |
| | Sizes | • Standard - 4 sizes<br>• Retentive - 4 sizes |
| | Components - Baseplate and Screws | |
| | Materials | • Titanium alloy with asymmetrical titanium bead<br>sintered coating |
| | Sizes | • Two lengths<br>• Convex back<br>• Titanium central compression screw<br>• Titanium peripheral polyaxial locking and non-locking<br>screws |
| | Components - Glenosphere | |
| | Materials | • Cobalt chromium alloy |
| | Sizes | • Concentric design in 2 sizes, lateralized<br>• Eccentric design in 3 sizes, lateralized |
| | Sterilization | • Provided sterile<br>• Gamma radiation |
| NONCLINICAL<br>TESTING | | The Integra TITAN Reverse Shoulder System has undergone performance testing to confirm the<br>system's ability to perform under expected clinical conditions. |
| | 1. | TP/TR -04-0172 rev A TSS Taper Axial Disassembly Force<br>This test report was previously submitted in K100448. The taper in the TITAN Total<br>Shoulder System is identical to the taper in the Reverse Shoulder system therefore<br>additional testing was not required. The test report concludes that the locking<br>efficiency of the AOI taper is acceptable. |
| | 2. | TP/TR-04-0245 Rev B TITAN Reverse Shoulder Body/Spacer to Liner Axial Disassembly<br>Test<br>The objective of this test was to verify that the force required to disassemble the TITAN<br>Reverse Shoulder System (RSS) humeral liner from the modular body or the humeral<br>spacer exceeds a biomechanically justified worst case load. The Spacer and Liner<br>assemblies of the TITAN Reverse Shoulder System met all acceptance criteria. |
| 3. TP/TR-04-0248 Dynamic Evaluation of Glenoid Baseplate Disassociation | The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) glenoid assembly does not loosen during cyclic loading representing one year of post-arthroplasty daily living. The TITAN Reverse Shoulder System Glenoid construct met all acceptance criteria. | |
| 4. TP/TR-04-0283 rev A RSS Fatigue Evaluation Test | The objective of this test was to verify that the modular TITAN Reverse Shoulder System (RSS) maintains functional integrity after enduring a challenging fatigue regimen representing 10 years of daily worst case post-arthroplasty cyclic loading in a simulated biological corrosive environment. The TITAN Reverse Shoulder System met all acceptance criteria. | |
| 5. TP/TR-04-0254-01 TITAN Reverse Shoulder System Glenosphere-Baseplate Taper Axial Disassembly Force | The purpose of this test was to determine the force required to disassemble the Glenosphere/Baseplate taper junction of the Integra TITAN Reverse Shoulder System. Heuristic models of the Reverse glenosphere male taper and baseplate female taper were tested as per ASTM F2009-00(2011). The taper design for the Glenosphere-Baseplate junction of the TITAN Reverse Shoulder System met all acceptance criteria. | |
| 6. TP/TR-04-0281 Rev A Reverse Shoulder System Liner Rotational Resistance Test Protocol | The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) humeral liner could withstand worst case torques created by rotation about the glenosphere without disassociating from the body implant or spacer implant. The rotational resistance at the interface of the Spacer and Liner of the TITAN Reverse Shoulder System met all acceptance criteria. | |
| 7. TP/TR-09-0082 Reverse Shoulder 4.5mm Screw Properties | The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 4.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 4.5mm screws met all acceptance criteria. | |
| 8. TP/TR-09-0083 Reverse Shoulder 5.5mm Screw Properties | The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 5.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 5.5mm screws met all acceptance criteria. | |
| 9. TR-09-0088 rev C Asymmatrix Coating Characteristics | The Humeral Bodies and Glenoid Baseplates of the Integra TITAN Reverse Shoulder System will be coated with Asymmatrix coating, a sintered asymmetrical titanium bead coating manufactured by Orchid Orthopedic Solutions, Memphis, Tennessee. The purpose of this document is to demonstrate that this coating meets the requirements for its intended use as provided in two FDA guidance documents. The Asymmatrix coating meets the requirements of the appropriate FDA guidance documents for use in the Integra Reverse Shoulder System. | |
| 10. TR-09-0249 rev B RSS Range of Motion | This document verifies the range of motion of the TITAN Reverse Shoulder System in flexion, abduction, internal rotation, external rotation and extension. The range of motion of the TITAN Reverse Shoulder System meets the performance requirements. The testing was conducted on worst case components or constructs according to standard test | |
| | methods, where possible. | |
| CLINICAL<br>PERFORMANCE<br>DATA: | Clinical performance data were not necessary to support substantial equivalence. | |
| BASIS OF<br>SUBSTANTIAL<br>EQUIVALENCE: | The TITAN Reverse Shoulder system is similar to the predicate devices in terms of indications<br>for use, intended use and fundamental scientific technology. Performance data demonstrates<br>that the subject device design is expected to perform as indicated. | |
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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.
