(235 days)
The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.
ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.
ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.
The provided text is a 510(k) summary for the ACMI Circon Semi-Rigid Ureteroscopes. This document is a premarket notification to the FDA for a medical device and does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.
Instead, the submission focuses on substantial equivalence to a predicate device. This means the manufacturer is asserting their new device is as safe and effective as a device already legally marketed. Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this type of document because it is not a performance study report for an AI/ML device.
Here's an assessment based on the available information:
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Table of acceptance criteria and reported device performance:
- Not applicable / Not provided. For a 510(k) based on substantial equivalence for a physical medical device like a ureteroscope, "acceptance criteria" are generally related to demonstrating similar technological characteristics, materials, and intended use as the predicate device, rather than performance metrics from a study against specific clinical endpoints. The document explicitly states the device "raise no new issues of safety or effectiveness," which serves as the primary "acceptance criterion" for this type of submission.
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Sample size used for the test set and data provenance:
- Not applicable / Not provided. No test set or data provenance is mentioned as this is not a study reporting on a specific performance measurement.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable / Not provided. No ground truth establishment for a test set is discussed. The device's safety and effectiveness are established by comparison to a predicate device, which itself would have been approved based on similar principles or pre-amendment status.
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Adjudication method for the test set:
- Not applicable / Not provided. No test set or adjudication method is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (a ureteroscope), not an AI/ML device. Therefore, no MRMC study or AI-related effectiveness is relevant or discussed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- Not applicable / Not provided. Ground truth, in the context of AI/ML device performance, is not relevant here. The "ground truth" for this submission is the legally marketed status and established safety/effectiveness of the predicate device (an ACMI Circon preamendment ureteroscope from circa 1971).
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The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device developed using training data.
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How the ground truth for the training set was established:
- Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.
Summary of Device and Approval:
- Device Name: ACMI Circon Semi-Rigid Ureteroscopes
- Intended Use: For use by qualified physicians to provide access to the urinary tract for diagnostic and therapeutic procedures.
- Predicate Device: ACMI Circon preamendment ureteroscope (circa 1971).
- Basis for Approval: Substantial equivalence to the predicate device. The submission asserts that the new ureteroscopes have similar technological characteristics (fiber optical lenses, working channels, semi-rigid shaft, connection to external light source) and intended use, and "raise no new issues of safety or effectiveness" compared to the predicate.
- Regulatory Status: Cleared by the FDA on April 9, 2002 via a 510(k) premarket notification as a Class II device (Endoscope and accessories, 21 CFR §876.1500).
§ 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.