(97 days)
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.
Subject Devices:
Model A2765 Working element, for probes
Model A0561 Guiding tube, for probes, with retractor
Model A0562 Guiding tube, for probes
Model A2891 Injection cannula, 1,2 mm x 420 mm
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Olympus Working Element for Probes.
Crucially, the provided document is a 510(k) summary for a medical device submitted to the FDA. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than presenting detailed, independent clinical studies with specific acceptance criteria and performance metrics like those for a novel AI device.
Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI-specific metrics is not available in this type of regulatory document. This summary primarily outlines the device's intended use and lists predicate devices.
Let's break down what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are stated, nor is there a report of device performance against such criteria.
This document is a 510(k) premarket notification, which establishes substantial equivalence through comparison to legally marketed predicate devices, not through a formal clinical trial with quantitative performance outcomes and pre-defined acceptance criteria. The "performance" demonstrated is implicitly that the device is as safe and effective as the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a "test set" in the context of an AI or diagnostic performance study. The 510(k) process relies on equivalence to predicate devices, material safety, and functionality, not a clinical study on a specific test set.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
Not applicable. There is no mention of a study involving experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is more common for evaluating diagnostic devices, especially those incorporating AI, to compare human performance with and without AI assistance. This document is for a medical instrument, not a diagnostic AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical working element for endoscopic procedures, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. As a mechanical device, the "ground truth" concept in the statistical sense for diagnostic or AI performance does not apply. Safety and efficacy are typically established through engineering tests, biocompatibility, sterilization validation, and comparison to predicate devices, not "ground truth" derived from patient data.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is irrelevant.
In summary: The provided 510(k) document is a regulatory submission for a medical instrument. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment, which are typical for diagnostic or AI-powered 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.