(486 days)
The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.
Not Found
This 510(k) summary for the Olympus SH-1 Surgical Holder for Telescope does not contain the detailed information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of AI/software device evaluation.
The provided document is for a mechanical surgical instrument (a telescope holder), not a software or AI-driven device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to diagnostic performance (e.g., sensitivity, specificity, AUC) are not relevant here.
Here's why the questions cannot be fully answered with the given input:
- Acceptance Criteria & Reported Performance (Table 1): Mechanical devices are typically evaluated based on engineering specifications, material properties, safety tests (e.g., biocompatibility, sterilization validation, strength, durability, ease of use), and performance claims like "securely holds telescope." These are not reported in the provided summary. The summary only states its intended use and comparison to predicates.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set Size, and Ground Truth for Training (Questions 2-9): These are all specific to the evaluation of diagnostic or prognostic software/AI algorithms. They relate to the quantitative assessment of an algorithm's ability to interpret data (like images or patient records) against a known truth. A mechanical telescope holder does not perform such interpretations. Its "performance" is based on its physical properties and functionality during surgery, which would be assessed through different types of testing (e.g., bench testing, cadaver studies, animal studies, human factors testing if applicable).
In summary, the provided document is a 510(k) summary for a traditional medical device, not a software device or AI-enabled device. Therefore, the questions posed, which are designed for the evaluation of AI/software performance, are not applicable to this device type and cannot be answered from the given information.
§ 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.