(76 days)
For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.
The provided text is a 510(k) summary for a medical device, the Vision-Sciences Flexible Cystoscope with EndoSheath® System. It describes the device, its indications for use, and a general statement about safety and performance. However, it does not contain the detailed study information needed to fully answer your request.
The 510(k) summary states that "Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing." This indicates that tests were performed, but the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any details about human reader studies are not present in this document.
Therefore, I can only provide a partial answer based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document only lists the types of performance tests conducted, not their specific criteria or results.
2. Sample size used for the test set and the data provenance
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in the provided text.
4. Adjudication method for the test set
Not available in the provided text.
5. 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 device is a flexible cystoscope with a sheath, not an AI-powered diagnostic tool. The concept of "human readers improve with AI" does not apply to this type of medical device based on the provided information.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a flexible cystoscope with a sheath, not an AI algorithm.
7. The type of ground truth used
Not available in the provided text. The performance tests mentioned (burst/leak, tensile/elongation, articulation, image quality, cycle testing) suggest engineering and functional performance parameters, which would likely have internal performance specifications as their "ground truth" rather than clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a flexible cystoscope with a sheath, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what can be inferred from the provided text:
- Acceptance Criteria & Performance: The document states that performance testing was performed for:
- Sheath burst/leak
- Sheath tensile/elongation
- Sheathed scope articulation
- Sheathed scope image quality
- Scope cycle testing
- However, the specific numeric acceptance criteria and the actual reported performance values are not disclosed in this 510(k) summary.
- Study Type: The studies mentioned are engineering and functional performance tests of the device components, not clinical studies involving patient data or expert interpretation in the way AI performance studies are conducted.
- Conclusion from the 510(k) Summary: "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Flexible Fiberoptic Cystoscope with EndoSheath® System has been shown to be safe and effective for its intended use." This indicates that the device did meet whatever acceptance criteria were established for the performance tests conducted, as this is a prerequisite for receiving 510(k) clearance.
§ 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.