Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.
Device Story
The Æqualis® Shoulder Prosthesis is a modular shoulder joint replacement system consisting of a humeral stem, humeral head, and optional glenoid component. The humeral stem is implanted into the humerus (press-fit or cemented), while the glenoid component is implanted into the scapula (cemented only). The device replaces the articular surfaces of the shoulder joint to restore function and reduce pain. It is intended for use by qualified orthopedic surgeons in a clinical/hospital setting. The surgeon selects appropriate component sizes based on pre-operative assessment and patient anatomy. The device provides a mechanical bearing surface to facilitate joint movement. Benefits include pain relief and improved joint mobility for patients with degenerative or traumatic joint conditions. The system requires specialized surgical instrumentation for implantation.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Materials: Titanium alloy (ISO 5832-3), Cobalt-chromium alloy (ISO 5832-4), UHMWPE (ISO 5834-2). Fixation: Uncemented (humeral) or cemented (humeral/glenoid). Sterilization: Gamma radiation. Components: Intramedullary humeral stem, humeral head, glenoid resurfacing component. Connectivity: None (mechanical implant).
Indications for Use
Indicated for patients with primary, secondary, or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain, or defective joint shape/function requiring shoulder arthroplasty or revision. Contraindicated in patients with acute/chronic infection, insufficient bone support, neuromuscular/psychiatric disorders affecting fixation, bone immaturity, known material allergies, obesity, or pregnancy.
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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# AUG 23 1999
K980244
immary of Safety and
ctiveness Information remarket Notification, Section 510(k)
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
#### Device Name: 1.
| Trade Name: | Æqualis® Shoulder Prosthesis |
|-------------------------|--------------------------------------------------------------------------|
| Common Name(s): | Press fit hemi-shoulder, when used without glenoid |
| | Press fit total shoulder, when used with glenoid |
| Classification Name(s): | Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis. |
| | And |
| | Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
#### Establishment Name & Registration Number: 2.
| Name: | Tornier S.A |
|---------|-------------|
| Number: | 8020756 |
#### Classification: 3.
\$ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the humerus and to be fixed without bone cement (888.3027). This device is not intended for biological fixation. (b) Classification. Class II.
And, when used as a total shoulder implant using a glenoid component,
888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) 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 ultrahigh molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See 8888.3.
| Device Class: | Class II & Class III, as above |
|-----------------------|--------------------------------|
| Classification Panel: | Orthopaedic |
| Product Code: | 87HSD & 87KWS respectively |
{1}------------------------------------------------
4
#### Company Contact: 4.
ﺗﻮ
Ms. Patricia Abraham, Marketing Manager Tornier, S.A. B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier France 011.334.7652.8000 011.334.7652.0673 - fax
### 5. Special Controls:
Special Controls do not apply to this device.
## 6. Substantially Equivalent Device(s):
Aqualis® Shoulder System (cemented), Tornier, S.A., K952928 Biomet Biomodular®, Biomet, Inc., K872454 Neer II®, Zimmer, Inc., K790987
## 7. Indications for use:
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.
### 8. Labeling
Federal (United States) Law restricts this device to sale by or on the order of a physician.
Known contra-Indications to dale. Acute or chronic infectious diseases of any etiology and localization, unsuitable or insufficient bone support preventing proper anchoring of the prosthesis, neuromuscular or psychiatric disorders which might jeopardize fixation and postoperative care, bone immaturity, known allerqy to one of the materials, obesity, pregnant women.
Dislocation, infection, early or late loosening, Side-effects and possible complications. neuropathies, cardiovascular disorders, tissue reaction, complications associated with wear of the prosthetic components, changes in dimensions of the operated limb, breakage of the component as a result r of changes or abnormal activity, and a reduction in the range of motion. Sonic complications may be accelerated by excessive weight gain on the part of the patient. Sonic side-effects may require a revision of the involved prosthesis. Some complications and side-effects may stem from a lack of awareness of the precautions for use mentioned below.
Warnings and cautions. Never re-use an implant, even if it appears in perfect condition.
Pre-operatively. The surgeon must be fully conversant with all the aspects of the surgical technique and know the indications and contra-indications of this type of implant. The surgeon must have acquainted himself before the operation with the specific operative technique of the product which is available from the manufacturer. As part of the pre-operative examination, the surgeon must check that no biological, biomechanical or other factors are present that will affect the correct conduct of the operation and the postoperative period. An appropriate range of sizes must be available at the time of the operation. Check that the implant has not suffered any deterioration.
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Per-operatively. The correct selection of the type and size of the implant appropriate to the patient and the positioning of the implant are extremely important. The functional surfaces of the implants must not suffer any damage, shock, abrasion or other deterioration.
Post-operatively. Patients must be informed by the surgeon of the precautions they must take in everyday life to quarantee the maximum implant service life. It is recommended that a regular postoperative follow-up is undertaken to detect early signs of wear loosening of the Prosthesis, etc., and to consider the action to be taken, Normal wear of the implant in respect of the state of knowledge at the time of its design cannot in any way be considered to constitute a dysfunction or a deterioration in the characteristic of the implant. A suitable rehabilitation program must be designed and implemented. See Appendix I for samples of labeling and instructions for use.
## 8. Description of the Device:
Materials. The specific material used in the Equalis® Shoulder Prosthesis is marked on the packaging. The press fit Æqualis® Shoulder Prosthesis is made from titanium alloy (TA6V4, titanium alloy in accordance with standard ISO 5832-3) and is used with humeral heads made of cobalt chromium alloy steel. This provides material compatibility with the existing line of Equalis® Shoulder implant humeral heads.
The use of the Æqualis® Shoulder Prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus of the shoulder and may be performed only by a gualified surgeon. The surgeon must operate in accordance with current information on the state of scientific progress and the art of surgery.
Storage and handling. The prosthetic components must be handled and stored with care in accordance with the provisions of standard ISO 8828. The implants must be stored in their sealed packaging of origin.
Packaging and sterilization. The implants are supplied sterilized (gamma radiation). The expiration date for sterilization must be checked. Only those products implanted before the end of the valid shelf-life may be considered sterile. The packaging and labeling must be checked for integrity. Reject any implant if the packaging shows any damage or has been previously opened. The opening instructions are written on the packaging. Every precaution must be taken to ensure sterility when opening the packaging of the implant and when inserting it.
Instrumentation. Specialized instruments are required to properly implant the Algualis® Shoulder Prosthesis system.
#### 9. Cleaning/Sterilization/Re-sterilization:
The implantable product is supplied sterile from the manufacturer. The device may not be secondarily cleaned or resterilized. Once the product packaging is opened or damaged, the product is no longer considered sterile. All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging renders the product unsafe and it should not be used. Shipping damaged product should be returned promptly. Subsequently damaged product packaging requires product replacement. Product used in the operating room must be opened and placed into use using accepted operating room sterile technique.
The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cycle is saturated steam at 270° F for 30 minutes.
{3}------------------------------------------------
# 10. Equivalence:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Based on the materials, intended uses, design and clinical performance and surgical technique, the Æqualis® Shoulder Prosthesis is substantially equivalent to the above referenced legally marketed devices.
# 11. Feature Comparison Table:
| FEATURE | Æqualis Press Fit | Æqualis Cement | Biomodular | Neer II | SE? |
|-----------------------------------------------------------------------|----------------------------------------|----------------------------------------|---------------------------------------|------------------------------------|-----|
| Indications for Use(s): | Hemi and total<br>shoulder replacment | Same | Same | Same | Yes |
| Materials:<br>Stem<br>Humeral Heads<br>Glenoid | Ti6Al4V<br>CoCr<br>UHMWPE | Same | Ti, 6AI,4V, Ti, CrCo | CrCo | Yes |
| Sizes:<br>Stem<br>Humeral Head<br>Glenoid | 7-15mm<br>12 sizes<br>3 sizes | Same | 6-13mm diameter<br>in 1mm increments | 6.3-12.7mm in<br>2mm<br>increments | Yes |
| Standards<br>Specifications:<br>Titanium<br>Cobalt-chromium<br>UHMWPE | ISO 5832-3<br>ISO 5832-4<br>ISO 5834-2 | ISO 5832-3<br>ISO 5832-4<br>ISO 5834-2 | ASTM F136<br>ASTM F90-87<br>ASTM F648 | | Yes |
| Method of Fixation: | Uncemented or<br>Cemented | Cemented | Uncemented or<br>Cemented | Uncemented or<br>Cemented | Yes |
| Manufacturer: | Tornier, S.A. | Tornier, S.A. | BioMet | Zimmer, 3M | Yes |
| K - Number | K980244 | 952928 | K872454 | K790987 | Yes |
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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
ﮩﺮ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 23 1999
Mr. David W. Schlerf Representing Tornier S.A. Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, California 94520
Re : K980244 Aequalis Press Fit Shoulder Prosthesis Regulatory Class: III Product Codes: KWS and HSD Dated: April 5, 1997 Received: April 13, 1997
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on the glenoid component of this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- The glenoid component of this device may not be labeled 1. or promoted for non-cemented use.
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the glenoid component is intended for cemented use only.
- Any non-cemented fixation of the glenoid component is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
{5}------------------------------------------------
Page 2 - Mr. David W. Schlerf
ﯩ
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
{6}------------------------------------------------
Page 3 - Mr. David W. Schlerf
obtained from the Division of Small Manufacturers Assistance
Carol Caronal (1984) can 2011 or (301) 443-6597 or 2 obtained from the Division of Small Manuracyard (201) 443-65597 or at
at its toll-free number (800) 638-2041 cc (400) " at its toll-tree number (800) 638-2041 of (302) 183-2007 100 (100 mm)
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Æqualis® Shoulder Prosthesis January 15, 1998
Page 1 ________of ____________________________________________________________________________________________________________________________________________________________ 1
Equalis® Shoulder Prosthesis Device Name:
Indications For Use:
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and other disorders in which arthrodesis is not an acceptable option.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980244 |
|---------------|---------|
|---------------|---------|
| Prescription Use | <div style="text-align: center;">+</div> | OR | Over-The-Counter Use | |
|----------------------|------------------------------------------|----|--------------------------|--|
| (Per 21 CFR 801.109) | | | (Optional format 1-2-96) | |
Press Fit.doc
.. '
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.
