Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Humeral head fracture - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable. Revision surgery when other treatments or devices have failed. The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.
Device Story
Aequalis Shoulder System is a modular total shoulder or hemi-arthroplasty prosthesis. System comprises humeral stem, humeral head, and glenoid components. Modification adds new Tornier Glenoid range (keeled or pegged anchorage) to existing system. Device used in orthopedic surgery to restore joint function and reduce pain. Surgeon implants components; glenoid component requires cement fixation. Modular design allows conversion from primary hemi-arthroplasty to total shoulder replacement. Benefits include pain relief and restoration of shoulder joint function for patients with severe degenerative or traumatic conditions.
Clinical Evidence
Bench testing only. Evaluations included range of motion, peripheral and central peg design influence on cement compaction and layer thickness, pull-out and shear testing, and subluxation/loosening tests on glenoid components. No clinical data presented.
Technological Characteristics
Shoulder joint metal/polymer semi-constrained cemented prosthesis. Materials: UHMWPE (ISO 5834-2) and CoCr alloy (ISO 5832-7). Fixation: Cemented. Anchorage: Keel or 4-peg design. Sizes: 4 (S, M, L, XL). Sterilization: Gamma radiation.
Indications for Use
Indicated for patients requiring total shoulder or hemi-arthroplasty to relieve severe pain or disability due to degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), primary/secondary humeral head necrosis, displaced 4-part upper humeral fractures, or humeral head fractures. Also indicated for revision surgery or cases where arthrodesis/resectional arthroplasty are unacceptable.
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.”
Affiniti Total and Hemi-Shoulder System (K060988, K103007)
Submission Summary (Full Text)
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## 11 902 Implants Chirr
#### Summary of Safety and Effectiveness information Special 510(k) Premarket Notification -- Aequalis Shoulder System
Date prepared: October 14th, 2011
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
#### 1) Device name
| Trade name: | Aequalis Shoulder System |
|----------------------|-----------------------------------------------------------------|
| Common name: | Total shoulder prosthesis |
| Classification name: | 888.3660 Shoulder joint metal/polymer semi-constrained cemented |
| | prosthesis |
#### 2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
#### 3) Applicant
Tornier, Inc. 7701 France avenue South Edina MN 55345 - USA
#### 4) Company contact
Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail: severine bonneton@tornier.fr
#### 5) Classification
| Device class: | Class II |
|-----------------------|------------|
| Classification panel: | Orthopedic |
| Product code: | KWS |
#### 6) Equivalent / Predicate device
Aequalis Shoulder System, Tornier, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007
Image /page/0/Picture/17 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and has a unique design, with the top part of the "T" appearing to be a separate piece. The hexagon provides a border around the "T", making it stand out. The logo is simple and monochromatic.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Tel. : 33 (0)4 76 61 35 00
Section 5 - Page 1/ page 4
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#### 7) Device description
The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists in a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Acqualis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder.
The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present device modification submission consists in the addition of a new glenoid system, named Tornier Glenoid, to the current cleared model. The Tornier Glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and Cortil oct 14 peg available in a variety of sizes.
The Tornier Glenoid has been designed to be compatible with the Aequalis, Affiniti and Ascend humeral head systems in certain combinations.
The new Tomier Glenoid completes the Tornier range of glenoid implants.
Tornier Glenoid component is intended for cemented use only.
#### 8) Materials
The glenoid implant is manufactured of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2 and from chromium cobalt alloy (radio wire) according to ISO 5832-7.
#### 9) Indications for use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic .
- arthrosis. Primary or secondary necrosis of the humeral head
- -Displaced 4-part upper humeral fracture
- Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable. Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.
Image /page/1/Picture/19 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of thick, geometric lines, giving it a modern and somewhat industrial appearance. The logo is black and white, with the "T" appearing to be slightly raised or embossed within the hexagon.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00
Section 5 - Page 2/ page 4
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# ાા વેળટ
#### 10) Summary of technological characteristics
| Main features or<br>system characteristics | Tornier<br>Glenoid<br>System | Aequalis<br>Shoulder<br>System | AffinitiTM<br>Shoulder<br>System |
|--------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------|
| Materials | UHMWPE<br>+<br>CoCr | UHMWPE<br>+<br>CoCr | UHMWPE |
| Shape | Pear shape | Pear shape | Pear shape |
| Method of fixation | cemented | cemented | cemented |
| Sizes | 4 sizes (S, M, L<br>and XL) for the<br>pegged and<br>keeled glenoid | Function of the<br>range: 3 to 6 sizes<br>for the pegged<br>and keeled<br>glenoid | 5 sizes<br>(40, 44, 48, 52<br>and 56) |
| Anchorage | 4 pegs or keel | 4 pegs or keel | 4 pegs or keel |
| Polyethylene thickness | 4mm | 2 to 4mm | 4mm |
| Indications for use | Total Shoulder<br>replacement | Total Shoulder<br>replacement | Total Shoulder<br>replacement |
| Terminal sterilization | Gamma | Gamma | Gamma |
| Manufacturer | Tornier | Tornier | Tornier Inc. |
| K-number | pending | K952928<br>K994392<br>K060209<br>K063081 | K060988<br>K103007 |
The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of the new Tornier Glenoid are similar or identical to the predicate devices.
#### 11) Non-clinical testing
Non-clinical testing was not necessary to determinate substantial equivalence between the new Tornier Glenoid and the cited predicate devices regarding:
- The indications for use of the new Tornier Glenoid are identical to the indications for use of the predicate Aequalis System (K952928, K994392, K060209 and K063081) and are very similar with the other predicate the Affiniti™ Shoulder System (K060988, K103007).
- ・ The intended use of the new Tornier Glenoid are identical to the intended use of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the Affiniti™ Shoulder System (K060988, K103007).
- The raw materials of the new components of the Tornier Glenoid are identical to the raw materials of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the Affiniti™ Shoulder System (K060988, K103007).
Image /page/2/Picture/9 description: The image shows a logo with two letters, 'T' and 'P', arranged in a stylized manner. The 'T' is positioned above the 'P', and both letters are designed with thick, bold lines. The logo is enclosed within a hexagon shape, which provides a border around the letters. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution image.
Tél. : 33 (0)4 76 61 35 00 TORNIEK S.A.S. 161. rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Section 5 - Page 3/ page 4
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Image /page/3/Picture/0 description: The image shows the word "TORNIER" in large, bold letters. Below that, the words "Implants Chirurgicaux" are printed in a smaller font. Above the word "TORNIER", there is a handwritten number, "K111902". The image appears to be a logo or label for a medical device company specializing in surgical implants.
- The fixation method of the new Tornier Glenoid is identical to the fixation method of the . predicate components of the Aequalis Shoulder System (K952928, K994392, K060209 and K063081 ) and the Affiniti Shoulder System (K060988, K103007).
The modifications made to the proposed Aequalis Shoulder System, addition of a new Tomier Glenoid range, were verified and validated by performing non-clinical testing:
- Bench test:
- · Range of motion
- Preliminary testings peripheral and central pegs design influence of cement o compaction & cement layer thickness
- 0 Pull out & shear testings on Tornier Glenoids
- Subluxation and loosening tests on glenoid components 0
The results of those evaluations allow us to conclude that the proposed new Tornier Glenoid described in this submission does not induce any new or higher risk compared to the predicate devices and therefore both devices (proposed and predicate) are substantially equivalent.
#### 12) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new Tornier Glenoid to the already cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- The Tornier Glenoid are compared to the predicate devices.
- The Tomier Glenoid have the same intended use as the Aequalis shoulder System and the . Affiniti™ Shoulder System are very similar indications for use.
- -Major technological characteristics are equivalent between the Tornier Glenoid and the predicate devices:
- Equivalence of general features •
- Equivalent polyethylene thickness -
- . Equivalent materials
- Equivalent means of fixation -
- Equivalent prosthetic dimensions .
Therefore, in light of the above information, the company believes that the Tornier Glenoid may be cleared via the 510(k) notification process for use as total shoulder prosthesis.
Image /page/3/Picture/20 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with the top bar extending beyond the vertical stem. The logo is black and white, with the 'T' being the most prominent feature.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 4/ page 4
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tornier, Inc. % Ms. Severine Bonneton Regulatory Affairs Specialist 161 Rue Lavoisier Montobonnot, Saint-Ismier France 38334
NOV - 3 2011
Re: K111902
- Trade/Device Name: Aequalis Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
- Regulatory Class: Class II Product Code: KWS Dated: October 14, 2011 Received: October 17, 2011
Dear Ms. Bonneton:
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
{5}------------------------------------------------
#### Page 2 - Mrs. Severine Bonneton
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Erin P. Keith
So Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
### Indications for Use
#### KI 1902 510(k) Number (if known):
Device Name: Aequalis Shoulder System
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
- -Displaced 4-part upper humeral fracture
- Humeral head fracture -
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chas to AXM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Tornier 510(k) Number _ Page 1 of 1
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.
