The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System. The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-K ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided or with the KMTI Lumbar Anchor System. Tesera-K SA ALIF assemblies (cage, lumbar anchors, screws and coverplate) featuring one or more lumbar anchors are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The coverplate assembly is required to be used if any anchors are implanted. Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The Kyocera Medical Technologies, Inc. (KMTI) Tesera-K XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-K XL System implants are to be used with autogenous or allogenic bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The KMTI Tesera-K XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.
Device Story
Lumbar Anchor System integrates with Tesera-K ALIF and Tesera-K XL systems to support foraminal height and decompression during spinal fusion; implants provide supplemental fixation. Used in surgical settings by orthopedic surgeons via direct anterior approach. Anchors are either machined or additively manufactured Ti-6Al-4V; non-sterile, steam-sterilized by user. System assemblies may be standalone or require additional supplemental fixation depending on cage lordotic angle and screw configuration. Output is mechanical stabilization of vertebral bodies; aids fusion process; benefits patients by addressing discogenic pain and spinal instability.
Clinical Evidence
Bench testing only. Performed dynamic cantilever bending (ASTM F2193), dynamic axial compression (ASTM F2077), and dynamic compression shear (ASTM F2077) to verify mechanical strength and equivalence.
Technological Characteristics
Materials: Ti-6Al-4V (ASTM F136 for machined, ASTM F3001 for additive). Principle: Mechanical interbody fusion and fixation. Form factor: Lumbar anchors in three sizes. Sterilization: Steam (autoclave). Connectivity: None.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1). DDD defined as discogenic back pain with radiographic degeneration. May include Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months (ALIF) or 6 weeks (XL) non-operative treatment.
Regulatory Classification
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
July 15, 2026
Kyocera Medical Technologies, Inc.
% Hannah Taggart
Engineer & Regulatory Specialist
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs, Colorado 80918
Re: K261353
Trade/Device Name: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: OVD, MAX
Dated: May 7, 2026
Received: May 7, 2026
Dear Hannah Taggart:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261353 - Hannah Taggart
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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,
# BRENT SHOWALTER -S
Brent Showalter, Ph.D.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K261353
Device Name
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
Tesera-K XL System
Lumbar Anchor System
Indications for Use (Describe)
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System.
The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-K ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment.
Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided or with the KMTI Lumbar Anchor System. Tesera-K SA ALIF assemblies (cage, lumbar anchors, screws and coverplate) featuring one or more lumbar anchors are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The coverplate assembly is required to be used if any anchors are implanted.
Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.
The Kyocera Medical Technologies, Inc. (KMTI) Tesera-K XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-K XL System implants are to be used with autogenous or allogenic bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The KMTI Tesera-K XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
☑
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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# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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EF
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# K261353 510(K) SUMMARY
| Submitter's Name: | Kyocera Medical Technologies, Inc. |
| --- | --- |
| Submitter's Address: | 1289 Bryn Mawr Ave., Ste. A Redlands, CA 92374 |
| Submitter's Telephone: | 909-557-2360 |
| Contact Person: | Hannah Taggart, MS, RAC ATS Colorado Springs 719- 457-1152 htaggart@atslab.com |
| Date Summary was Prepared: | July 10, 2026 |
| Trade or Proprietary Name: | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System Tesera-K XL System Lumbar Anchor System |
| Device Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Classification & Regulation #: | Class II per 21 CFR §888.3080 |
| Product Code: | OVD, MAX |
| Classification Panel: | Orthopedic |
## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System consists of implants designed to integrate with the KMTI Tesera-K SA Anterior Lumbar Interbody Fusion (ALIF) System and the Tesera-K XL System to support foraminal height and decompression between lumbar or lumbosacral vertebral bodies during spinal correction and fusion as well as reusable instruments to assist in anchor implantation.
The Lumbar Anchor implants are offered in both traditionally machined Ti-6Al-4V per ASTM F136 and additively manufactured from Ti-6Al-4V per ASTM F3001. The Lumbar Anchor implants are non-sterile packaged and intended to be steam sterilized by the end user. The Lumbar Anchors implants are offered in three sizes to meet patient anatomical needs.
## INDICATIONS FOR USE
The Kyocera Medical Technologies, Inc. (KMTI) Lumbar Anchor System is indicated for use with the KMTI Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System and Tesera-K XL System.
The KMTI Tesera-K ALIF System is indicated for interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-K ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment.
Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided or with the KMTI Lumbar Anchor System. Tesera-K SA ALIF assemblies (cage, lumbar anchors, screws and coverplate) featuring one or more lumbar anchors are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine. The coverplate assembly is required to be used if any anchors are implanted.
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Tesera-K SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-K SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-K SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.
The Kyocera Medical Technologies, Inc. (KMTI) Tesera-K XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-K XL System implants are to be used with autogenous or allogenic bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. The KMTI Tesera-K XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.
## TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same between the subject and predicates:
- Indications for Use
- Structure and Function
- Materials of manufacture
- Sterility
- Sizes
- Manufacturing and Biocompatibility
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
| --- | --- | --- | --- | --- |
| K212980 | Tesera-k ALIF System | KMTI | OVD, MAX | Primary |
| K222554 | EL Captain ALIF | Astura Medical | OVD | Additional |
| K242771 | Tesera-k XL System | KMTI | MAX, OVD | Additional |
The subject device is different from the predicate devices in the following ways:
- There subject anchors are provided in traditionally manufactured and additively manufactured options. The predicate system does not offer an additively manufactured anchor. This difference was addressed through dynamic cantilever bend testing side-by-side with a cleared predicate anchor to show substantial equivalence.
There are no differences between the subject and predicate devices which raise questions for the safety and efficacy of the subject devices.
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# PERFORMANCE DATA
The Tesera-K SA ALIF System with Lumbar Anchor System has been tested in the following test modes:
- Dynamic Cantilever Bending per ASTM F2193
- Dynamic Axial Compression per ASTM F2077
- Dynamic Compression Shear per ASTM F2077
The results of this non-clinical testing show that the strength of the Tesera-K SA ALIF System with Lumbar Anchor System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
# CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Tesera-K SA ALIF System and Tesera-K XL System with Lumbar Anchor System is substantially equivalent to the predicate device.
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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.
