K993503 · International Advanced Medical Enterprises, Inc. · MNH · Apr 14, 2000 · Orthopedic
Device Facts
Record ID
K993503
Device Name
HAIDER-UCR SPINAL SYSTEM
Applicant
International Advanced Medical Enterprises, Inc.
Product Code
MNH · Orthopedic
Decision Date
Apr 14, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are: The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. 2. Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are: The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion pseudarthrosis).
Device Story
The HAIDER-UCR Spinal System is a posterior pedicle screw-based spinal fixation system. It consists of titanium alloy pedicle screws, rods, housings, caps, washers, and crosslinks. The device is used by orthopedic surgeons in a clinical/surgical setting to provide immobilization and stabilization of spinal segments as an adjunct to fusion. The surgeon implants the system into the thoracic, lumbar, and sacral spine to treat various instabilities or deformities. By providing rigid fixation, the system maintains spinal alignment and stability, facilitating the fusion process. The implants are intended for removal after solid fusion is achieved. The system is supplied non-sterile and requires steam sterilization by the end-user prior to surgery.
Clinical Evidence
Bench testing only. Static and fatigue testing were performed according to ASTM F-1717-96, including compression bending, tension bending, and torsion tests. Cyclic fatigue testing established an S/N curve, with at least two run-out points exceeding 5,000,000 load cycles.
Technological Characteristics
Constructed from 6Al-4V titanium alloy. System components include pedicle screws (7.0mm diameter), rods (5.5mm diameter), crosslinks, and associated hardware. Operates as a mechanical fixation system. Supplied non-sterile; requires steam sterilization (gravity cycle, 270°F/125°C for 15 minutes).
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for severe spondylolisthesis (Grades 3-4, L5-S1), degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or failed previous fusion (pseudarthrosis) in the thoracic, lumbar, and sacral spine.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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# APR 1 4 2000
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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
#### 1. Device Name:
HAIDER-UCR Spinal System
Common Name(s): Pedicle screw spine system
Classification Name(s): Pedicle Screw Spinal System
#### 2. Establishment Information:
| Name: | INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC |
|----------|-------------------------------------------------|
| Number: | 9033791 |
| Address: | 5360 Preserve Parkway, S |
| | 909.682.9616 - 909.682.9620 - fax |
| | Greenwood Village, CO 80121 |
#### 3. Classification:
& 888.3070 - Spondylolisthesis Spinal Fixation Device System & 888.3070 - Pedicle Screw Spinal System (Class II Uses)
Device Class: Class II for the requested indications Classification Panel: Orthopaedic and Rehabilitation Devices Panel Product Codels): MNH. MNI respectively
#### Equivalent Predicate Device: 4.
Synergy™ Spinal System: K974749, Cross Medical Products, Inc. (now Interpore Cross International).
#### 5. Device Description:
Indications for Use: when used as a Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar. and sacral spine:
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- degenerative spondylolisthesis with objective evidence of neurological impairment, .
- . fracture,
- dislocation, ●
- . scoliosis,
- kyphosis, ●
- spinal tumor, and .
- failed previous fusion pseudarthrosis). .
### The system components include:
| Component | Catalog Number | Level of Use |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------|
| Titanium Pedicle screw<br>7.0mm dia., Assembled<br>7.0mm X 35mm<br>7.0mm X 40mm<br>7.0mm X 45 mm | 40-35<br>40-40<br>40-45 | T-10 to Sacrum<br>T-10 to Sacrum<br>T-10 to Sacrum |
| Pedicle Screw Components<br>Set Screw<br>Washer<br>Cap<br>Housing | 60-10<br>60-15<br>60-20<br>60-25 | T-10 to Sacrum<br>T-10 to Sacrum<br>T-10 to Sacrum<br>T-10 to Sacrum |
| Screw Sub-Assembly<br>7.0mm X 35mm<br>7.0mm X 40mm<br>7.0mm X 45 mm | 60-35<br>60-40<br>60-45 | T-10 to Sacrum<br>T-10 to Sacrum<br>T-10 to Sacrum |
| Crosslink<br>Cross Link Nut<br>Cross Link Hook<br>Cross-link Bar-60mm<br>Cross-link Bar-70mm<br>Cross-link Bar-80mm | 50<br>55<br>70-60<br>70-70<br>70-80 | L-1 to L-5<br>L-1 to L-5<br>L-1 to L-5<br>L-1 to L-5<br>L-1 to L-5 |
| 5.5 mm Titanium Rods<br>5.5mm X 305mm | 95 | T-10 to Sacrum |
| Accessories<br>Hex 3mm Screw Driver<br>Hex 4mm Screw Driver | 300<br>400 | |
Materials: The system is made from a well known metallic alloy commonly known as titanium alloy or 6Al, 4V, Ti titanium alloy. This material meets or exceeds the quality and composition standards listed in the table below:
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Testing Summary: Static and fatigue testing were conducted. Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system quideline. Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5.000.000 load cycles.
#### 7. Company Contact:
Todd L. Ackarman Requiatory Affairs IAME, INC.
#### 8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
#### 9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM. Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
IAME, INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
#### 10. Special Controls:
Special controls were published in the Federal Register, Vol. 63, No. 143, July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:
- (i) Compliance with material standards,
- (ii) Compliance with mechanical testing standard,
- (iii) Compliance with biocompatability standard, and
- (iv) Compliance with specified labeling requirements.
### 11. Storage, Packaging & Sterilization Information:
The HAIDER-UCR Spinal System is supplied "NON-STERILE" and must be sterilized prior to use.
The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°
## The validated cycle is:
Method: Steam Cycle: Gravity Temperature: 270°F (125°C) Exposure Time: 15 minutes
23
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All packages containing implants or instruments should be intact upon receipt. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.
| FEATURE | HAIDER-UCR Spinal System | Synergy™ Spinal System | SE? |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----|
| Indications for<br>Use: | degenerative spondylolisthesis with objective evidence of<br>neurological impairment,<br>fracture,<br>dislocation,<br>scoliosis,<br>kyphosis,<br>spinal tumor, and<br>failed previous fusion pseudarthrosis). | SAME | YES |
| Materials: | Titanium alloy | SAME | YES |
| Design: | Rod, sacral screw, pedicle screw & cross link system | SAME | YES |
| Sterile: | Supplied Non-sterile<br>Autoclave processed by end user | SAME | YES |
| Sizes: | Rods: 5.5mm dia. X 40-305mm length<br>Pedicular screws 7.0mm 35mm, 40mm, 45mm | EQUIVALENT | YES |
| Manufacturer: | IAME, Inc. | Interpore/Cross | YES |
| Product Code: | MNH, MNI | SAME | YES |
| K - Number: | Pending | K974749 | YES |
### 12. Summary Comparison Table:
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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# APR 1 4 2000
Mr. David W. Schlerf Buckman Company, Inc. c/o IAME, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K993503 Trade Name: HAIDER-UCR Spinal System Regulatory Class: II Product Code: MNH and MNI Dated: January 10, 2000 Received: February 24, 2000
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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. David W. Schlerf
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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Danne R. Vochner.
1 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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Page 1 of 1
X 493503 510(k) Number :_______________________________________________________________________________________________________________________________________________________________
Device Name(s): HAIDER-UCR Spinal System
## Intended Use Statement(s):
- 1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
- The HAIDER-UCR Spinal System is a pedicle screw system indicated for the . treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
- 2. Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
- . The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- degenerative with objective evidence of neurological ● spondylolisthesis impairment,
- . fracture,
- dislocation, ●
- scoliosis, .
- kyphosis.
- spinal tumor, and ●
- failed previous fusion pseudarthrosis). .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmns D. Lochner.
(Division Sig -Off) Division of Ceneral Restorative Devices 510(k) Number_K99350 Z
X Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
UCR.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.
