(22 days)
The Smith & Nephew 660HD Image Management System is intended to capture intraoperative still and motion images.
The Smith & Nephew 660HD Image Management System is a computer based system which interacts with medical camera systems and non-medical devices such as A/V equipment, audio equipment, printers and monitors. The 660HD System provides a convenient means to capture video data from the medical camera system and archive it to removable storage media. In addition the 660HD System provides a mechanism to transfer data to a network location and to import/export procedure information from certain repository systems that are already part of the Hospital Information System.
The provided text does NOT describe specific acceptance criteria for device performance or a study that proves the device meets such criteria. It states that "All verification and validation data demonstrates that the device is safe and effective and performs as intended." but does not provide any specifics about this data or how it was collected or analyzed.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, or ground truth establishment based on the provided input.
However, I can extract information regarding standards conformance:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as performance criteria for image capture) | Reported Device Performance |
|---|---|
| Conformance to voluntary safety and electromagnetic compatibility standards | Device conforms to: |
- IEC 60601-1 (1998) + Amd 1 (1991) + Amd 2 (1995) (UL 2601-1)
- IEC 60601-1-1 (1992) + Amd 1 (1995), (2000)
- IEC 60601-1-2 (2001-09)
- UL 60601-1 (2003)
- CAN/CSA 22.2 No. 601.1 (1990) + Supp. No. 1-94 (1994) |
| Safety and effectiveness as intended | "All verification and validation data demonstrates that the device is safe and effective and performs as intended." |
No information is available for the following points within the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
- 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 mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned; this device is an image management system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned; this is an image management system, not an algorithm being evaluated for standalone performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 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.