(23 days)
The Intuitive Surgical Endo Wrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci® Surgical System (Model 1S4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The da Vinci Xi 12 - 8 mm Reducer is a sterile, single use hollow cylinder with an integrated seal that is inserted into the da Vinci Xi 12 mm & Stapler Cannula/Cannula Seal assembly to support the use of da Vinci Xi 8 mm instruments and endoscopes.
The Reducer consists of three components - a tube, handle, and an integrated seal to allow a da Vinci Xi 8 mm instrument or endoscope to be used with a 12 mm & Stapler Cannula while maintaining pneumoperitoneum. The latch on the Reducer snaps onto the da Vinci Xi Stapler Cannula Seal by a molded-in latch flexure on the device.
The provided document describes the da Vinci Xi 12 - 8 mm Reducer and its substantial equivalence to a predicate device. It does not contain information about the performance of a software-driven or AI-based medical device. Therefore, many of the requested fields related to AI performance, ground truth, expert consensus, and reader studies are not applicable or cannot be extracted from this document.
However, I can extract information related to the device's functional performance and the testing conducted to ensure its safety and effectiveness.
Here's the closest possible answer based on the provided text, recognizing that it's for a mechanical medical device, not an AI system:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Reported Performance / Outcome (Pass/Fail) |
|---|---|---|
| Mechanical | Insertion force | Tested & Verified |
| Retraction force | Tested & Verified | |
| Insertion friction | Tested & Verified | |
| Latch disengagement force | Tested & Verified | |
| Insertion axis range of motion | Tested & Verified | |
| Functional | Internal seal leak rate | Tested & Verified |
| Maintains pneumoperitoneum | Confirmed (with compatible components) | |
| Compatibility | Compatibility with cannulas | Confirmed |
| Compatibility with cannula seals | Confirmed | |
| Compatibility with size-compatible endoscopes | Confirmed | |
| Compatibility with size-compatible instruments | Confirmed | |
| Dimensional | Dimensional requirements | Tested & Verified |
| Labeling | Adequacy of labeling for compatibility | Tested & Verified |
| Overall | Intended Use Functionality | Confirmed in animal model |
| Met Design Input Requirements | Confirmed | |
| Safe and Effective for Intended Use | Confirmed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test. The document mentions "tests with an animal model" but does not give a specific number of animals or trials. For bench tests, it's implied that sufficient samples were tested to verify the requirements, but no numbers are provided.
- Data Provenance: Not specified, but tests were conducted by Intuitive Surgical, Inc. (Sunnyvale, CA, USA).
- Retrospective or Prospective: Testing appears to be prospective as it's part of design verification and validation for a new/modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided as this is a mechanical device, not an AI system that requires expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are typically relevant for subjective assessments, particularly in clinical studies or AI performance evaluation. The tests described are objective engineering and functional verifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable and not provided. This is for a mechanical reducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. This pertains to an algorithm's performance, not a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional and mechanical tests, the "ground truth" (or reference standard) was established by engineering specifications and design input requirements. For the animal model, the ground truth was the intended functional outcome (e.g., maintaining insufflation, proper instrument use) as observed and measured against predefined criteria.
8. The sample size for the training set
- This information is not applicable and not provided. This refers to AI/machine learning models, which are not described here.
9. How the ground truth for the training set was established
- This information is not applicable and not provided. This refers to AI/machine learning models, which are not described here.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.