(204 days)
The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
The OES ELITE Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The OES ELITE Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The OES ELITE Telescopes will be marketed as individual telescopes. The OES ELITE Telescopes are available in 4 mm diameters with four different directions of view (0°, 12°, 30°, 70°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k). The OES ELITE Telescopes will be delivered with a protective tube WA2P400A which is subject to this 510(k) submission.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Olympus OES ELITE Telescopes and Protective Tube. This document describes the device, its intended use, and its comparison to a predicate device, along with performance data.
However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance Table: The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007" and "Performance tests were carried out to ensure that the system functions as intended and meets design specifications." It then lists various types of tests conducted (biocompatibility, electrical safety, thermal safety, optical/mechanical performance, shipping, service life, illumination system, design validation/usability). However, it does not provide a specific table of acceptance criteria metrics (e.g., minimum resolution, defined field of view, specific sterility assurance level) or the quantitative results from these tests against those criteria. It only broadly states that the tests were conducted and the device "comply[s] with the intended use."
- Sample size and data provenance for test set: The document mentions "Performance tests" and "design validation/usability tests" were conducted, but it does not specify the sample sizes used for these tests, nor does it detail the provenance of any data (e.g., country of origin, retrospective/prospective). Given the nature of an endoscope, the testing would likely involve bench testing and possibly some limited in-vivo or ex-vivo testing, but the details are absent.
- Number of experts and qualifications for ground truth: There is no mention of experts being used to establish a ground truth for a test set. The device is an endoscope for visualization, meaning its "performance" is more related to its physical build, optical quality, and safety/sterility, rather than an AI's diagnostic accuracy against a ground truth from experts.
- Adjudication method: Not applicable as there is no mention of expert review or a test set requiring adjudication in the context of diagnostic accuracy.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is typically for AI-assisted diagnostic tools comparing human performance with and without AI. The OES ELITE Telescope is an imaging device, not an AI diagnostic tool.
- Standalone (algorithm only) performance: Not applicable. This device is a manual endoscope, not an algorithm.
- Type of ground truth used: Not explicitly stated as "ground truth" in the diagnostic sense is not relevant for this device's type of performance testing (which focuses on physical and optical specifications, safety, and reusability). The "ground truth" would implicitly be the established engineering specifications and standards against which the device passed its tests.
- Sample size for training set: Not applicable. This is a physical medical device, not a machine learning algorithm.
- How ground truth for training set was established: Not applicable. This is a physical medical device, not a machine learning algorithm.
In summary, the provided text is a regulatory submission for a physical medical device (an endoscope) and not for an AI/ML-based diagnostic system. Therefore, the types of acceptance criteria, study designs, and data provenance details you are looking for, which are common for AI/ML devices, are not present.
The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety and performance standards (like ISO 14971, ISO 10993, IEC 60601, and ISO 8600 series for endoscopes), which are crucial for physical medical devices.
§ 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.