(87 days)
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.
The SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope consists of a sterile, disposable, protective sheath which covers the pation of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
Here's a breakdown of the acceptance criteria and study information for the Modified EndoSheath® for VSI Fiberoptic Sigmoidoscope, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sheath Functional and Performance Test | Performed and deemed safe and effective |
| Sheath Tensile Test | Performed and deemed safe and effective |
| Microbial Barrier Testing (live polio virus) | Performed and deemed safe and effective |
| Microbial Barrier Testing (Phi X 174 bacteriophage) | Performed and deemed safe and effective |
Note: The document states that these tests were performed and, based on them, the device was concluded to be safe and effective. However, it does not provide specific numerical thresholds or detailed results for what constitutes "meeting" these criteria (e.g., a specific tensile strength value, or a quantified reduction in viral load). It simply indicates that the tests were conducted and the device passed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the "Sheath Functional and Performance Test 1," "Sheath Tensile Test," or the microbial barrier testing. It also doesn't explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of these in vitro tests, it's highly likely they were conducted in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For in vitro functional and barrier tests, "experts" in the traditional sense of clinical diagnosticians establishing ground truth might not be directly applicable in the same way it would be for image-based AI studies. Rather, the ground truth would be established by the testing methodology itself (e.g., successful containment of pathogens, ability to withstand a certain force).
4. Adjudication Method (for the test set)
The document does not mention any adjudication method, as it's not relevant to the described in vitro testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, not for an in vitro medical device like the EndoSheath.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, in a sense, a "standalone" evaluation was done. The tests described (Sheath Functional and Performance, Tensile, Microbial Barrier) evaluate the device's performance properties in isolation, without human intervention as a variable in the outcome of the test.
7. The Type of Ground Truth Used
The ground truth for these tests is based on pre-defined physical and biological performance characteristics.
- For the Sheath Functional and Performance Test, the ground truth would be the successful operation of the sheath in its intended function with the sigmoidoscope.
- For the Tensile Test, the ground truth would be the ability to withstand a specified tensile force without failure.
- For Microbial Barrier Testing, the ground truth would be the effective containment/prevention of passage of the specified viruses (polio virus and Phi X 174 bacteriophage).
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI/ML algorithm that requires a "training set." Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained above, this question is not applicable to this product.
§ 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.