(73 days)
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals.
S - 35 9 Video Imaging
The provided text is a 510(k) summary for the SOPRO S-357 Video Imaging System. This document asserts substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.
Therefore, the document does not contain information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, or adjudication methods.
Here's an explanation of why the requested information cannot be extracted from the given text:
- Substantial Equivalence (510(k)) vs. Performance Studies: The 510(k) pathway for medical device approval in the US focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance claims to the predicate. It does not generally require de novo clinical trials or rigorous performance studies with predefined acceptance criteria in the same way a PMA (Pre-Market Approval) or some other regulatory pathways might.
- Content of the 510(k) Summary: The summary states: "SOPRO feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already In commercial distribution are : Circon/ACMI, Storz, Stryker, Smith & Nephew and Olympus, just to name a few. The design of the S-357 is virtually identical to the comparative devices... Since the design is comparable, tcchnology virtually identical, the specifications very similar, and the intended use the sames. SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device." This clearly indicates a comparative approach based on similarity, not an independent performance study with measurable outcomes.
Thus, I cannot fill in the requested table or answer the questions related to performance studies, ground truth, or expert involvement because the provided text does not contain that information.
The document does provide:
- Device Name: S - 359 Video Imaging (though the summary refers to S-357, and the FDA letter refers to "Video Endoscopic Camera" and uses K972540, implying the S-357/S-359 are closely related or the same product with a minor naming discrepancy in the document).
- Intended Use/Indications For Use: "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals."
§ 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.