Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
Applicant
Covidien, LLC
Product Code
GAG · General Hospital
Decision Date
Jul 1, 2026
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4740
Device Class
Class 2
Attributes
Therapeutic, PCCP
Indications for Use
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
Device Story
Tri-Staple™ 2.0 black circular reloads are single-use surgical stapling components; used with Signia™ battery-powered, microprocessor-controlled stapler and circular adapters. Device places circular triple-staggered rows of titanium staples (4.0mm, 4.5mm, 5.0mm heights); integral knife blade resects excess tissue to create anastomosis. Operated by qualified medical professionals in sterile operating room environments. Provides push-button powered firing. Benefits include consistent staple formation and tissue resection for alimentary tract procedures. Subject devices introduce 21mm and 25mm lumen sizes.
Clinical Evidence
No clinical testing was required. Evidence consists of bench-top, in-vivo, and ex-vivo animal testing, chronic animal testing, sterilization validation (ISO 11135), biocompatibility (ISO 10993-1), electrical safety (ANSI/AAMI ES 60601-1/IEC 60601-1), EMC (IEC 60601-1-2), and usability evaluation (IEC 62366-1).
Technological Characteristics
Titanium staples; triple staggered row configuration; 4.0mm, 4.5mm, 5.0mm staple heights; 21mm and 25mm lumen sizes. Battery-powered, microprocessor-controlled actuation via Signia™ stapler. Sterile, single-use. Complies with ISO 11135 (sterilization), ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).
Indications for Use
Indicated for patients requiring alimentary tract anastomoses (end-to-end, end-to-side, side-to-side) in open or laparoscopic surgery.
Regulatory Classification
Identification
Surgical stapler for external use: A specialized prescription device used to deliver compatible staples to skin during surgery. Surgical stapler for internal use: A specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
*1* ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
*2* ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
*3* ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
*4* ) Avoidance of use of the stapler on the aorta;(
*5* ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
*6* ) Ensuring stapler compatibility with staples; and(
*7* ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
Predicate Devices
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629)
EEA Circular Stapler with Tri-Staple Technology (K202507)
EEA Circular Stapler with Tri-Staple Technology (K221771)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 01, 2026
Covidien, LLC
Frank Maistrovich
Principal Regulatory Affairs Specialist
60 Middletown Ave.
North Haven, Connecticut 06473
Re: K253527
Trade/Device Name: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
Regulation Number: 21 CFR 878.4740
Regulation Name: Surgical Stapler
Regulatory Class: Class II
Product Code: GAG, GDW
Dated: June 1, 2026
Received: June 1, 2026
Dear Frank Maistrovich:
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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K253527 - Frank Maistrovich
Page 2
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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
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K253527 - Frank Maistrovich
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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-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,
TEK N. LAMICHHANE -S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253527 | ? |
| Please provide the device trade name(s). | | ? |
| Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | | |
| Please provide your Indications for Use below. | | ? |
| The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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K253527 Page 1 of 3
# 510(k) Summary
510(k): K253527
Date Prepared: 01-Jul-2026
Contact Details
| Applicant Name | COVIDIEN LLC |
| --- | --- |
| Applicant Address | 60 Middletown Ave. North Haven CT 06473 United States |
| Applicant Contact Telephone | 952.738.2339 |
| Applicant Contact | Mr. Frank Maistrovich |
| Applicant Contact Email | Frank.D.Maistrovich@medtronic.com |
Device Name
| Device Trade Name | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) |
| --- | --- |
| Common Name | Surgical stapler |
| Classification Name | Stapler, Surgical |
| Regulation Number | 878.4740 |
| Product Code(s) | GAG, GDW |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K221629 | Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) | GAG |
| K202507 | EEA Circular Stapler with Tri-Staple Technology | GDW |
| K221771 | EEA Circular Stapler with Tri-Staple Technology | GDW |
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K253527 Page 2 of 3
## Device Description Summary
Tri-Staple™ 2.0 black circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as end-to-end, end-to-side, or side-to-side anastomosis as the user sees fit. The black circular reloads deploy three height progressive rows of 4.0mm, 4.5mm, and 5.0mm staples. The subject Tri-Staple™ 2.0 black circular reload introduces new lumen sizes of 21 and 25mm.
The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use.
The Tri-Staple™ 2.0 black circular reloads and the Signia™ circular adapters are for use with the Signia™ stapler. The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling applications.
## Intended Use / Indications for Use
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
## Indications for Use Comparison
The subject device indications for use are identical the predicate indications for use.
## Technological Comparison
The Tri-Staple™ 2.0 black circular reloads are offered in new lumen sizes 21mm and 25mm have the same intended use, material, design (except size), and operational principles as the predicate Tri-Staple™ 2.0 black circular reloads. The subject devices also have the same intended use and lumen size range as the secondary predicates, manual EEA™ Circular Stapler with Tri-Staple™ Technology (K202507 / K221771).
## Non-Clinical and/or Clinical Tests Summary & Conclusions
### Performance / Non-Clinical Testing
The following non-clinical testing was performed:
- Sterilization per ISO 11135;
- Stability/Shelf Life;
- Biocompatibility per ISO 10993-1;
- Electrical safety per ANSI/AAMI ES 60601-1 & IEC 60601-1 and electromagnetic compatibility (EMC) per IEC 60601-1-2;
- Performance testing including bench top, in-vivo and ex-vivo animal testing;
- Chronic animal testing;
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K253527 Page 3 of 3
• Usability evaluation per IEC 62366-1.
Other testing areas/categories are unaffected, and the predicate testing continues to be valid.
### Clinical Testing
No clinical testing was required.
### Predetermined Change Control Plan (PCCP)
*Planned Modification*
The predetermined change control plan (PCCP) for the device specifies an anticipated modification to the TILT-TOP anvil used with TRI-STAPLE 2.0 circular reload family of devices. PVC tubing will be attached to the anvil to create a transoral, “ORVIL” anvil.
*Test Method and Validation Activities*
The PCCP also specifies the methods to implement the ORVIL modification so that the device remains as safe and as effective as the predicate device. The testing will be completed in accordance with the authorized PCCP and will include the following:
- Sterilization per ISO 11135;
- Stability/Shelf Life;
- Performance testing including bench top.
*Communication to Users, as needed*
In order to communicate implementation of the modification to users, TRI-STAPLE 2.0 circular reloads including ORVIL will be sold under / labeled with new, unique device numbers. TRI-STAPLE 2.0 circular reloads including ORVIL will also be packaged with an Instructions for Use document specific for devices including ORVIL.
### Conclusion
Based upon the supporting data summarized above, the Tri-Staple™ 2.0 black circular reloads 21mm and 25mm, when used with the existing Signia™ stapler, demonstrates substantial equivalence to the legally marketed 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.
