USTAR II Knee System 1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed. 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed. 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis. 4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis. 5. Joint instability resulting from excessive bone resection. For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only. For Distal Femoral Component. RHS/ Proximal Tibial Component. RHS/ Tibial stem/ Segment Part. RHS, Bridge: These devices are single use implant and intended for cementless use only. USTAR II Knee System, Stem 1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed. 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed. 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis. 4. Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement. 5. Joint instability resulting from excessive bone resection. Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only. USTAR II Hip System 1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed. 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed. 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis. 4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis. 5. Joint instability resulting from excessive bone resection. This device is a single use implant and intended for cementless use only.
Device Story
Modular orthopedic salvage system for knee and hip reconstruction; addresses large bone loss, deformity, or failed arthroplasty. Knee system includes femoral components, tibial baseplates, inserts, augments, and stems; hip system includes proximal femoral components, trochanteric claws, and straight/curved stems. Implants are single-use; specific components designated for cemented or cementless fixation. Used by orthopedic surgeons in clinical settings to restore joint function and stability following massive resection or revision surgery. Benefits include structural support and joint restoration for complex orthopedic cases.
Clinical Evidence
No clinical data provided. Safety and effectiveness established via bench testing, including hyperextension fatigue, rotation, wear/corrosion, stem/neck fatigue, range of motion, disassembly force, and surface treatment evaluation. Bacterial endotoxin testing met USP <161> limits.
Technological Characteristics
Modular knee and hip prosthesis system. Materials include metal and polymer. Fixation via cemented or cementless (press-fit) methods. Features include femoral/tibial components, augments, and stems. Sterilization method not specified. No software or electronic components.
Indications for Use
Indicated for patients requiring massive resection and transplantation due to metastatic tumors (osteosarcoma, chondrosarcoma, giant cell tumor, osteoma) or severe trauma; non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis, traumatic arthritis); revision of failed arthroplasty, osteotomy, or arthrodesis; and joint instability from excessive bone resection.
Regulatory Classification
Identification
A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 23, 2019
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 TAIWAN
Re: K190100
Trade/Device Name: USTAR II System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, LPH, LWJ, KWL Dated: August 14, 2019 Received: August 22, 2019
Dear Lois Ho:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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) K190100
Device Name USTAR II System
Indications for Use (Describe)
USTAR II Knee System
1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
- 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
- 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
- 4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. Joint instability resulting from excessive bone resection.
For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.
For Distal Femoral Component. RHS/ Proximal Tibial Component. RHS/ Tibial stem/ Segment Part. RHS, Bridge: These devices are single use implant and intended for cementless use only.
#### USTAR II Knee System, Stem
1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.
- 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
- 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
- 5. Joint instability resulting from excessive bone resection.
Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.
#### USTAR II Hip System
1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
- 2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
- 3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
- 4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
- 5. Joint instability resulting from excessive bone resection.
This device is a single use implant and intended for cementless use only.
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)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image contains the logo for United Orthopedic Corporation. The logo features a green circular icon with a white circle inside, resembling the letter 'U'. To the right of the icon, the word "United" is written in a bold, dark gray font. Below "United", the words "Orthopedic Corporation" are written in a smaller, lighter gray font.
# 510(k) Summary of K190100
| Submitter Information | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | United Orthopedic Corporation |
| Address | No.57, Park Ave. 2, Science Park, Hsinchu City 30075, |
| | Taiwan. |
| Phone Number | +886-3-5773351 ext. 2220 |
| Fax Number | +886-3-577156 |
| Name of Contact Person | Lois Ho, Regulatory Affairs Manager |
| Date prepared | January 08, 2019 |
| Device Information | |
| Trade Name | USTAR II System |
| Common Name | Total Knee Prosthesis / Total Hip Prosthesis |
| Classification Panel | Orthopedics |
| Regulation Name and<br>Number | Knee joint femorotibial metal/polymer constrained<br>cemented prosthesis (21CFR 888.3510);<br>Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis (21 CFR 888.3358) |
| Regulatory Class | Class II |
| Product Code(s) | KRO, LPH, LWJ, KWL |
| Predicate Device(s) | 1. “United” U2 Total Knee System – PSA Type (K082424,<br>K100981, K122183) |
| | 2. “Zimmer” NexGen® Complete Knee Solution Rotating<br>Hinge Knee (K013385) |
| | 3. “Zimmer” Zimmer® Segmental System (K070978,<br>K110940) |
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Image /page/5/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circular symbol with a white dot in the center, followed by the word "United" in a bold, gray font. Below the word "United" is the phrase "Orthopedic Corporation" in a smaller, lighter gray font.
Orthopaedic Salvage System (K002757, 4. "Biomet" K052685) 5. "Zimmer" Arcos Modular Femoral Revision System (K130063) 1. "United" UTF Stem, reduced, Ti plasma spray (K123550) "United" UCP Stem (K152530) 2. 3. "United" U2 Hip stem, cemented (K111546) "Stryker" Global Modular Replacement 4. System (K023087)
- 5. "Zimmer" Vanguard™ DCM tibial insert (K100048)
# Reference Device(s)
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Image /page/6/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green stylized "U" shape with a white circle inside, followed by the word "United" in a bold, dark gray font. Below "United" is the text "Orthopedic Corporation" in a smaller, lighter gray font.
#### Device Description:
"United" USTAR II System is used for patients who need a special prosthesis for their particular indication, which may present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, one tumors resection, or trauma and may require a further operation or reconstruction.
USTAR II System includes two sub-systems, which is "USTAR II Knee System" and "USTAR II Hip System". USTAR II Knee System is designed as modular combinations. It offers a variety of component options for treatment of patients that require femoral component, tibial baseplate and tibial insert. The tibial augment, segment part and stem are provided for patient with more bone resection. USTAR II Hip System is designed as a modular system which is composed Proximal femoral component, Trochanteric claw, and Press-fit, RHS straight/curved stem.
#### Indications for Use:
## USTAR II Knee System
Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
Joint instability resulting from excessive bone resection.
For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These
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Image /page/7/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo consists of a green circle with a white dot inside, followed by the word "United" in gray, and the words "Orthopedic Corporation" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.
devices are single use implant and intended for cemented use only.
For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.
## USTAR II Knee System, Stem
Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) resulting from trauma where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Correction for revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement.
Joint instability resulting from excessive bone resection.
Cemented Tibial Stem is a single use implant and intended for cemented use only. Tibial Stem is a single use implant and intended for cementless use only.
## USTAR II Hip System
Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
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Image /page/8/Picture/1 description: The image shows the logo for United Orthopedic Corporation. The logo features a green stylized "U" with a white circle inside, followed by the word "United" in a bold, dark gray font. Below "United" is the text "Orthopedic Corporation" in a smaller, lighter gray font.
Joint instability resulting from excessive bone resection.
This device is a single use implant and intended for uncemented use only.
#### Comparison of Technological Characteristics with the Predicate Device:
The features of the subject device are comparable to the predicates mentioned above in terms of the indication for use, design rationale, materials, coating and sterilization method. The differences have been validated by several testing to demonstrate that the performance of subject device is substantially equivalent to that of the predicate devices.
#### Performance Data:
## ● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subject device:
- a. Hyperextension fatigue test
- b. Internal and external rotation
- c. Wear and corrosion test
- d. Stem fatigue test
- e. Neck fatigue test
- f. Range of Motion
- g. Disassembly Force and Fretting Corrosion
- h. Evaluation of Modified Surface Treatment
- i. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP <161>.
Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
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Image /page/9/Picture/1 description: The image contains the logo for United Orthopedic Corporation. The logo consists of a green circular symbol with a white circle inside, resembling the letter 'U'. To the right of the symbol, the word "United" is written in a bold, dark gray font. Below "United", the words "Orthopedic Corporation" are written in a smaller, lighter gray font.
# ● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
# ● Substantial Equivalence Conclusion:
The subject device has the same intended use, materials, coating, sterilization method, and similar design features to the predicates mentioned above. The performance results demonstrate that the subject device is as safe and effective as the legally marketed predicate devices. Based on the information provided, "United" USTAR II System is considered substantially equivalence to that of 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.
