EndoWrist Stapler 45 System and Stapler 45 Reloads
K171388 · Intuitive Surgical, Inc. · NAY · May 31, 2017 · Gastroenterology, Urology
Device Facts
Record ID
K171388
Device Name
EndoWrist Stapler 45 System and Stapler 45 Reloads
Applicant
Intuitive Surgical, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
May 31, 2017
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
To resect, transect and/or create anastomoses in surgery.
Device Story
Reusable surgical stapler system for use with da Vinci Si Surgical System (Model IS3000). Device places multiple staggered rows of implantable staples in target tissue followed by mechanical transection. Used in hospital settings by surgeons. System includes stapler instrument, motor pack, and single-use staple cartridges (3.5mm or 4.3mm). Modifications include stainless steel cam with corrosion-resistant properties and carbon coating, and removal of carbon coating from anvil surfaces. Device facilitates tissue approximation and hemostasis during robotic-assisted procedures.
Clinical Evidence
Bench testing and animal model validation. Bench testing included load testing (3X max load), cleaning/sterilization cycles, and reliability/life testing. Animal model testing evaluated tissue approximation, hemostasis, and staple formation. Results confirmed performance meets design requirements and raises no new safety or effectiveness concerns.
Technological Characteristics
Reusable robotic surgical stapler. Materials: Stainless steel (cam with corrosion-resistant properties and carbon coating), anvil (uncoated). Energy: Powered by da Vinci Si Surgical System motor pack. Sterilization: Steam (instrument), EO (reloads). Connectivity: Interfaces with da Vinci Si system via cannula/obturator/seal accessories.
Indications for Use
Indicated for use with the da Vinci Si Surgical System (Model IS3000) for resection, transection, and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. Compatible with staple line or tissue buttressing material (natural or synthetic).
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 31, 2017
Intuitive Surgical, Inc. Ms. Doreen Nakamura Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K171388
Trade/Device Name: EndoWrist Stapler 45 System and Stapler 45 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY. GDW Dated: May 10, 2017 Received: May 11, 2017
Dear Ms. Nakamura:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/1/Picture/8 description: The image shows the signature of Jennifer R. Stevenson. The signature is written in a clear, legible font. The word "Sincerely" is written above the signature. The signature appears to be from a formal document.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K171388
Device Name
EndoWrist Stapler 45 System and Stapler 45 Reloads
Indications for Use (Describe)
The Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line and tissue buttressing material (natural or synthetic).
Type of Use (Select one or both, as applicable)
| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------|
| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## K171388
#### 510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Doreen Nakamura, R.A.C.<br>Sr. Regulatory Affairs Specialist<br>Phone Number: 408-523-0595<br>Fax Number: 408-523-8907<br>Email: Doreen.Nakamura@intusurg.com |
| Date Summary Prepared: | May 16, 2017 |
| Trade Names: | EndoWrist® Stapler 45 System and Stapler 45 Reloads |
| Common Name: | Endoscopic instruments and accessories |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories<br>21 CRF 878.4750, Implantable Staple |
| Product Codes: | NAY (Endoscope and accessories)<br>GDW (Implantable Staple) |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Predicate Devices: | K113706– EndoWrist Stapler 45 System and Stapler 45<br>Reloads |
#### Device Description
The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and Accessories is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS3000). It is intended for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery by placing multiple rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
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The implantable staples, trade name Stapler 45 Reloads, are provided in a separate single use cartridge and are available in the following two configurations to accommodate tissues of various thickness:
- . 3.5 mm staple size single use reload (Blue Reload)
- . 4.3 mm staple size single use reload (Green Reload)
Accessories, including cannula, obturator, cannula reducer, and a cannula seal, are provided to support the interface of the EndoWrist® Stapler 45 with the da Vinci Surgical System (Model IS3000).
## Intended Use:
To resect, transect and/or create anastomoses in surgery.
#### Indications for Use:
The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
## Technological Characteristics:
The modification to the design of the predicate Stapler 45 Instrument is a change in materials to the distal end of the device. This change does not impact the intended use and the fundamental scientific technology of the device. The modified device (subject) and the current device (predicate) share similar technological characteristics.
## Performance Data:
In accordance with the Design Control process, risk analysis was conducted to evaluate the impact of design modifications on the predicate device. Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use.
Image /page/4/Picture/15 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a lighter gray color with a registered trademark symbol to the right of it. There is a small yellow dot above the "I" in "INTUITIVE".
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# Comparison:
The predicate device used for the determination of substantial equivalence is the previously cleared EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706). See comparison in Table 1.
| Item | Subject Device<br>EndoWrist Stapler 45 System and<br>Stapler 45 Reloads | Predicate Device<br>EndoWrist Stapler<br>45 System and<br>Stapler 45<br>Reloads<br>(K113706) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Devices, Trade Name | EndoWrist® Stapler 45 System and<br>Stapler 45 Reloads | IDENTICAL |
| Product Code | NAY | IDENTICAL |
| Regulation Number<br>and Name | 21 CFR 876.1500, Endoscope and<br>Accessories | IDENTICAL |
| Classification Advisory<br>Committee | General and Plastic Surgery | IDENTICAL |
| Classification | II | IDENTICAL |
| Intended Use | To resect, transect and/or create<br>anastomoses in surgery. | IDENTICAL |
| Indications for Use | The EndoWrist Stapler 45 System and<br>EndoWrist Stapler 45 Reloads are<br>intended to be used with the da Vinci Si<br>Surgical System (Model IS3000) for<br>resection, transection and/or creation of<br>anastomoses in General, Gynecologic<br>and Urologic surgery. The device can<br>be used with staple line or tissue<br>buttressing material (natural or<br>synthetic). | IDENTICAL |
| Prescription Use | Physician use only | IDENTICAL |
| Where used (hospital,<br>home ambulance, etc.) | Hospital | IDENTICAL |
| Mechanism of action | The stapler instrument achieves its<br>intended function by placing multiple<br>staggered rows of implantable staples<br>in the target tissue followed by cutting<br>of the target tissue along the middle of<br>the staple line. | IDENTICAL |
| | | Table 1: Device Comparison |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Item | Subject Device<br>EndoWrist Stapler 45 System and<br>Stapler 45 Reloads | Predicate Device<br>EndoWrist Stapler<br>45 System and<br>Stapler 45<br>Reloads |
| Stapler Motor Pack and<br>cable | Stapler Motor Pack 372300<br>Cable 372032 | (K113706)<br>IDENTICAL |
| Stapler Reloads<br>Sterilization Method | Blue 41645B<br>Green 41445G<br>EO | IDENTICAL<br>IDENTICAL |
| Manual Unclamp Tool<br>(EndoWrist Stapler<br>Release Kit) | EndoWrist Stapler Release Kit 381181 | IDENTICAL |
| Stapler Cannula Kit | EndoWrist Stapler Cannula Kit 420378 | IDENTICAL |
| Stapler Sheath | Stapler Sheath 410370 | IDENTICAL |
| Stapler 45 Instrument<br>Type of Use<br>Sterilization Method | Stapler 45 Instrument 410298<br>Reusable<br>●<br>Steam<br>● | IDENTICAL |
| Stapler 45 Instrument<br>Labeling Change | Labeling divided into two documents<br>and added Wall Chart<br>Stapler Instrument and<br>●<br>Accessories Manual<br>Reprocessing Instructions<br>●<br>Wall Chart (derivative of<br>●<br>Reprocessing Instructions) | Stapler<br>Instrument and<br>Accessories<br>Manual<br>containing<br>Reprocessing<br>Instructions.<br>Section 4 |
| Stapler 45 Instrument<br>Cam Change | Stainless steel with better corrosion<br>resistant properties and carbon coating<br>on all surfaces | Stainless steel, no<br>coating |
| Stapler 45 Instrument<br>Anvil Change | Carbon coating removed from anvil<br>surfaces interfacing with cam | Carbon coating<br>present on all<br>surfaces, except<br>for cosmetic top<br>surface |
| Stapler 45 Instrument<br>Marking Change | "Autoclave" added to instrument<br>housing | Not present |
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# EndoWrist Stapler 45 System and Stapler 45 Reloads
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EndoWrist Stapler 45 System and Stapler 45 Reloads
#### Design Verification
Table 2 lists design verification testing performed on both subject and predicate devices and sub- assemblies.
| Testing | Summary |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design<br>Verification | Appropriate verification testing was performed on the subject<br>device to evaluate design specifications such as physical,<br>mechanical, and any requirements that may be affected by the<br>design change.<br><br>Distal subject device subassemblies built with the new cam material<br>were subjected to a 3X the maximum calculated load.<br><br>Subject devices were cleaned and sterilized and then tested for<br>clamp, fire, electrical connectivity of reload and Stapler Motor<br>Pack.<br><br>Subject device and subject device sub-assemblies met design<br>verification specifications. |
| Design<br>Verification<br>Sub-Assembly | Appropriate verification testing was performed on the subject<br>device sub-assembly to evaluate design specifications such as<br>environmental assisted cracking susceptibility and requirements<br>that have been affected by the design change.<br><br>Subject device sub-assemblies met design verification<br>specifications. |
| Reliability/Life<br>Testing | Verification testing was performed to evaluate requirements that<br>may be affected by the design change. Subject devices were fired,<br>clamped and reprocessed for the estimated life of the product.<br><br>Subject device met reliability/life specifications. |
| | | Table 2: Design Verification Performed | |
|--|--|----------------------------------------|--|
|--|--|----------------------------------------|--|
## Design Validation:
Design Validation testing was performed on subject and predicate devices to confirm the subject device meets the user needs and intended use in a clinical setting. The testing summarized in this submission validates general, functional, and interaction (compatibility) requirements for the subject device. Tests with an animal model evaluated performance based on comparative tissue approximation, hemostasis, and staple formation in accordance with its intended use. Design Validation results confirm the design modifications to the Stapler 45 Instrument do not raise any new questions of safety and effectiveness.
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# Summary:
The subject EndoWrist Stapler 45 System and Stapler 45 Reloads and the predicate EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706) have the same intended use, indications for use, technological characteristics, performance data, and utilize the same disposable accessories and instrument accessories. The results of the design verification and validation tests do not raise new issues of safety and effectiveness.
In conclusion, the EndoWrist Stapler 45 System and Stapler 45 Reloads described in this submission is substantially equivalent to the predicate device.
Image /page/8/Picture/5 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in light gray, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".
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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.
