The Aequalis Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. The BLUEPRINT 3D planning software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.
Device Story
System comprises patient-specific titanium drill guides and 3D planning software. Software imports patient CT-scan data (DICOM) to allow surgeons to visualize, measure, reconstruct, and annotate anatomy; plan glenoid implant positioning; and design patient-specific guides. Software generates surgery report and 3D file for guide fabrication. Guides assist surgeons in intraoperative positioning of glenoid components during total anatomic shoulder arthroplasty. Used in clinical settings by orthopedic surgeons. Benefits include improved surgical planning and precise intraoperative component placement based on patient-specific anatomy.
Clinical Evidence
Bench testing only. Validation performed using cadaver specimens to assess accuracy of preoperative planning and patient-specific guide fit. Dimensional testing confirmed titanium guides meet specifications. Guiding wire tests verified version angle, inclination angle, and entry point errors were within acceptable limits.
Technological Characteristics
Hardware: Ti6Al4V (ISO 5832-3) patient-specific drill guides manufactured via 3D printing. Software: 3D planning application for Windows/Mac OS; supports DICOM CT-scan import. Connectivity: Connected to Online Management System (OMS). Single-use, non-sterile.
Indications for Use
Indicated for adult patients undergoing total anatomic shoulder arthroplasty. Used by surgeons to assist in intraoperative positioning of glenoid components and pre-surgical planning based on patient-specific CT scans. Contraindicated if necessary anatomic reference points are absent on CT scan.
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.”
Predicate Devices
BLUEPRINT Patient Specific Instrumentation (K143374)
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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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Tornier S.A.S. Aymen Azaiez Regulatory Affairs Specialist 161, Rue Lavoisier 38330 Montbonnot Saint Martin FRANCE
Re: K160555
Trade/Device Name: BLUEPRINT Patient Specific Instrumentation Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS Dated: February 22, 2016 Received: February 29, 2016
Dear Aymen Azaiez:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 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" (21 CFR 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,
# Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
#### 510(k) Number (if known) K160555
#### Device Name
BLUEPRINT Patient Specific Instrumentation
#### Indications for Use (Describe)
The hardware
The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide.
BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| 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)
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# Summary of Safety and Effectiveness information Special 510(k) Premarket – BLUEPRINT™ Patient Specific Instrumentation
| 1) Device name | |
|----------------------|-------------------------------------------------------------------------------|
| Trade name: | BLUEPRINT™ Patient Specific Instrumentation |
| 510(k) Number: | K160555 |
| Common name: | Patient specific instrumentation + 3D planning software |
| Classification name: | Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented<br>(§888.3660) |
2) Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
## 3) Company contact :
Tornier SAS Mr Aymen AZAIEZ Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : aymen.azaiez@tornier.com
## 4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
# 5) Equivalent / Predicate device :
BLUEPRINTTM Patient Specific Instrumentation, Tornier SAS (K143374) Delta TT Acetabular System, Limacorporate S.p.A. (K112898)
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# 6) Device description :
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software).
BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.
## The hardware
The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use.
The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
## The software
BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement).
It is intended to help to plan an operation by allowing surgeons to:
- position and select the glenoid implant,
- design a patient specific pin guide. ●
## This submission seeks clearance for:
- Hardware: a guide made of Titanium with an orientation hole which allows । for controlling rotation of the commercially available implant, AequalisTM PerFORM
- । Software modified to:
- · Integrate a guide made of titanium,
- o Add a glenoid sphere radius measurement.
These modifications do not affect the intended use or the indications for use of the device or alter the fundamental scientific technology of the device.
## Intended Use
## The hardware
The Aequalis Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder GFM-00000123 REV B - Tornier Appendix IV
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Image /page/5/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, bold, blue font.
arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
## The software
The BLUEPRINT 3D planning software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.
## 7) Materials :
The commercially available Aequalis Glenoid Guides are manufactured from medical grade polyamide 2200. This 510k seeks clearance for guides made of medical grade titanium (Ti6Al4V).
## 8) Indications :
## The hardware
The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
# The software
The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems.
The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT 3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patientspecific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
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## 9) Summary of technological characteristics
| Table 1 Main features comparison | | | |
|-----------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|
| Main features or<br>system<br>characteristics | BLUEPRINTTM Patient Specific<br>Instrumentation<br>SUBJECT DEVICE SYSTEM | BLUEPRINTTM<br>Patient Specific<br>Instrumentation<br>(K143374)<br>PRIMARY | Delta TT Acetabular<br>System (K112898)<br>REFERENCE |
| Material | Ti6AI4V | Polyamide 2200 | Ti6AI4V |
| Standard | ISO 5832-3 | USP Class VI<br>compatible | ISO 5832-3<br>ASTM F 1472 |
| Manufacturing | 3D printing | 3D printing | 3D printing |
| Product Code | KWS | KWS | LPH, MBL |
| Surgical procedure | Total anatomic shoulder<br>arthroplasty | Total anatomic<br>shoulder arthroplasty | Hip replacement |
| Single-use | Yes | Yes | Yes |
| Sterile | No | No | Yes |
| Manufacturer | Tornier SAS | Tornier SAS | Limacorporate S.p.A. |
| Software | Assist surgeon in pre-operative<br>surgical planning | Assist surgeon in pre-<br>operative surgical<br>planning | NA |
# ты
Implants Chirur
Device comparison showed that the proposed device is substantially equivalent:
- in intended use and performance characteristics to the predicate device ।
- in material to the reference device ।
## 10) Non-clinical testing
BLUEPRINT™ Patient Specific Instrumentation was validated through studies using cadaver specimens. Non clinical testing was performed on BLUEPRINT™ Patient Specific Instrumentation to assess that no new safety or effectiveness questions were raised with this device.
| Validation and / or<br>Verification Method | Acceptance Criteria description | Verification<br>and<br>Validation<br>Results |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Patient Specific<br>Guiding Wire test | Version angle error, inclination angle error, main<br>(central) entry point error and rotation entry point<br>error must be compliant with device specifications | Acceptable |
| Dimensional test of The<br>titanium guide | The titanium guide meets dimensional<br>specifications | Acceptable |
## Table 2: Non-clinical testing
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This testing aimed to validate that the software measures in preoperative planning (implant positioning with a human cadaver) with the modified Blueprint Software generated a patient specific glenoid guide matching the patient anatomy.
Implants Chirurgica
## 11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of BLUEPRINT™ Patient Specific Instrumentation to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision making Process:
- -BLUEPRINT™ Patient Specific Instrumentation (pending device) is compared to the predicate device and the reference device.
- -BLUEPRINT™ Patient Specific Instrumentation (pending device) has the same intended use as the predicate device: BLUEPRINT™ Patient Specific Instrumentation (k143374).
- BLUEPRINT 3D planning software (pending device) is equivalent to the BLUEPRINT -3D planning software (k143374).
- -BLUEPRINT 3D planning software (pending device) user manual is similar in indications precautions, warnings, and instructions as the predicate device: (k143374).
- -Major technological characteristics are equivalent between BLUEPRINT™ Patient Specific Instrumentation (pending device) and the predicate device:
- Equivalence of general features -
- -Equivalent surgical procedures
- Equivalent intended use, indications for use
- BLUEPRINT™ Patient Specific Instrumentation (pending device) is considered equivalent to the reference device Delta TT Acetabular System (K112898) in material.
- -BLUEPRINT™ Patient Specific Instrumentation (pending device) differs from the predicate device BLUEPRINT™ Patient Specific Instrumentation (K143374) regarding two features: the orientation hole intended to help the surgeon to control the rotation of the commercially available implant, Aequalis™ PerFORM, and glenoid sphere radius measurement to facilitate choosing the implant Aequalis™ PerFORM. These differences do not, however, change the fundamental technology, principle of operation for the drill guide/software or intended use.
## Therefore, in the light of the above information, the BLUEPRINT™ Patient Specific Instrumentation is considered equivalent to the predicate devices
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.
