(299 days)
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The EndoWrist One Vessel Sealer is an electrosurgical sealing and cutting instrument to be used in conjunction with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. The outside diameter (O.D.) of the instrument shaft is 8.5 mm and the working length is 38 cm. The instrument is provided sterile and is a single-use, disposable device. The distal end has jaws with bipolar electrodes for sealing vessels and contains a cutting blade that extends through the jaws to transect sealed vessels and other tissues. The sealing and cutting functions are operated by the da Vinci Si Surgical System foot pedals.
The ERBE VIO 300 D generator provides the high frequency (radio frequency) electrical current for tissue sealing.
The provided text is a 510(k) summary for the Intuitive Surgical EndoWrist One Vessel Sealer, which describes the device and its intended use, and states that performance tests (bench and animal lab tests) were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any comparative effectiveness study results. Therefore, I cannot complete most of the requested table and answer many of the subsequent questions based solely on the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT PROVIDED | NOT PROVIDED |
Explanation: The document states "Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or effectiveness as compared to the predicate devices." However, it does not specify what those "design input requirements" or "acceptance criteria" were, nor does it provide quantitative performance data (e.g., vessel sealing strength, time to seal, burst pressure, etc.).
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 provided. The document mentions "bench and animal lab tests" but does not specify the number of samples, animals, or tests conducted.
- Data Provenance: Not provided.
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)
- Not applicable/Not provided. The tests mentioned are "bench and animal lab tests," which typically involve direct measurement of physical or physiological parameters, rather than expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As mentioned above, the tests are primarily objective measurements.
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
- No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (vessel sealer), not an AI-driven diagnostic or interpretative tool that would involve human readers. The study performed was to demonstrate substantial equivalence of a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense, a standalone performance assessment was done for the device itself. The "bench and animal lab tests" evaluate the intrinsic performance of the vessel sealer in sealing and transecting vessels, independent of human variability in technique, though human operators would be performing the procedures. This isn't an "algorithm only" test as it's a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "bench tests," the ground truth would typically be established by validated measurement techniques and scientific standards (e.g., burst pressure measurements, tensile strength, seal integrity).
- For "animal lab tests," the ground truth would likely involve direct observation, physiological measurements (e.g., blood pressure, hemorrhage), and potentially histological examination of sealed vessels. The document doesn't specify which particular metrics were used.
8. The sample size for the training set
- Not applicable. This device is a mechanical/electrosurgical instrument, not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device does not use a "training set."
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through "bench and animal lab tests" for a medical device. It does not provide the detailed scientific study design, specific performance metrics, or information relevant to AI-based diagnostic tools.
§ 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.