(2 days)
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.
Proxis™ Ureteral Access Sheath is a two component ureteral dilation system which contains 1) a sheath with a lumen for passage of endoscopes and related instruments and 2) a dilator with a lumen for passage over a guidewire and injection of fluids.
Proxis™ Ureteral Access Sheath is a hydrophilic-coated sheath tube comprised of a coil reinforced polymer with a PTFE liner and marker band near the distal end. On the proximal end of the sheath is a plastic hub which provides identification for the device and acts as an interface for introducing endoscopes and related instruments through the sheath. The dilator is comprised of a hydrophiliccoated polymer tube with a tapered distal end and a female luer connector with a lock mechanism on the proximal end to attach and lock to the hub on the sheath. The device will be offered in multiple sizes to accommodate different patient anatomies. The product is ethylene oxide sterilized (per ISO 11135:2014, Sterilization of health care products – ethylene oxide – Requirements for development, validation and routine control of a sterilized process for medical device is for single use.
The provided text describes a 510(k) premarket notification for a medical device called the Proxis™ Ureteral Access Sheath. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and a study proving those criteria are met in the way a clinical performance study for an AI/ML device would.
Therefore, many of the requested categories are not applicable to this document. The document details non-clinical performance testing and biocompatibility testing to show the device is safe and effective in comparison to a predicate device.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
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Table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in a quantitative manner for a clinical study comparing the device's diagnostic or predictive performance against a ground truth. Instead, it refers to compliance with established international and national standards for medical devices and comparison to a predicate device.
Acceptance Criteria Reported Device Performance Compliance with BS EN 1616:1997 + A1:1999 (Sterile urethral catheters for single use) Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements") Compliance with ISO 594-2:1998 (Conical fittings with a 6% (Luer) taper) Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements") Compliance with JIS T 3260:2012 (Dilators) Achieved (implied by "Nonclinical performance testing (bench) of the proposed device was conducted per the applicable requirements") Biocompatibility in accordance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 Achieved (implied by "Nonclinical biocompatibility testing was conducted...") Similar performance characteristics to predicate device (Boston Scientific Navigator™ HD Ureteral Access Sheath Set) Demonstrated by "Additional testing was completed to compare additional performance characteristics of the subject and predicate devices." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing and biocompatibility testing for the physical device, not a test set of data for an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI/ML device performance (e.g., expert consensus on image interpretation) is not relevant to this type of device and study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" in the context of diagnostic performance data requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (ureteral access sheath), not an AI/ML diagnostic or assistive device.
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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 (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced standards (e.g., BS EN 1616, ISO 594-2, JIS T 3260, ISO 10993-1). For the comparative performance, the "ground truth" would be the established performance characteristics of the predicate device.
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The sample size for the training set
Not applicable. This is a physical medical device; there is no "training set" of data.
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How the ground truth for the training set was established
Not applicable.
§ 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.