(85 days)
The Olympus SEPS System is designed for subcutaneous endoscopy -- more specifically, for endoscopically gaining access to vessels (arteries veins, ducts, nerves) in subcutaneous and subfascial surgical planes in the lower extremities for endoscopic observation, diagnosis, and treatment.
Not Found
The provided text describes a 510(k) submission for the Olympus SEPS System but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary, specifically the FDA's clearance letter and the manufacturer's statement of intended use. It focuses on the regulatory classification and the determination of substantial equivalence to predicate devices, rather than performance or efficacy studies.
Therefore, I cannot provide the requested information based on the given text.
If this were a typical device submission with performance data, the following would be the expected information:
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Table of Acceptance Criteria and Reported Device Performance: This would typically be a table comparing pre-defined thresholds for performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device; or specific functional requirements for a surgical device) against the results achieved in a study.
- Example for an imaging device:
Metric Acceptance Criteria Reported Performance Sensitivity > 90% 92.5% Specificity > 80% 85.1% Accuracy > 85% 88.0%
- Example for an imaging device:
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Sample size used for the test set and the data provenance: This would state how many cases were used to evaluate the device's performance and where that data came from (e.g., 200 patient cases from a multi-center retrospective study in the USA and Europe).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail the number of clinicians who provided the reference standard for the test data and their relevant experience (e.g., 3 board-certified radiologists, each with 10+ years of experience in thoracic imaging).
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Adjudication method for the test set: How disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if the first two disagree; 3+1 means three experts agree, or a fourth adjudicates).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Yes/No, and if yes, the effect size for human readers with/without AI assistance.
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If a standalone (algorithm only without human-in-the-loop performance) was done: Yes/No, and the results if applicable.
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The type of ground truth used: What the reference standard was based on (e.g., histopathology, clinical follow-up, consensus of multiple experts, outcome data).
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The sample size for the training set: How many cases/data points were used to train the algorithm (for AI/ML devices).
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How the ground truth for the training set was established: Similar to point 7, but specifically for the data used to teach the algorithm.
§ 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.