The EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes 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.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for a medical device, the Modified EndoSheath® for VSI Flexible Sigmoidoscopes, by Vision Sciences Inc. This document focuses on demonstrating the substantial equivalence of the modified device to previously cleared predicate devices through functional and microbial barrier testing.

However, the provided text does not contain the level of detail required to fulfill all the requested information categories, particularly regarding the specifics of clinical studies, expert involvement, and ground truth establishment typically found in comprehensive device performance reports for AI/diagnostic tools. The device described is a physical sheath, and the testing focuses on its physical properties and barrier function, not diagnostic accuracy in the way an AI algorithm would be evaluated.

Therefore, for several categories, the response will state that the information is "Not applicable" or "Not provided in the text."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Air/Water Tubing Tensile/Elongation Test	Sufficient strength and elasticity for intended use with sigmoidoscopes. (Implicit, based on functional test)	Performed (Specific results not detailed, but implied to be acceptable for 510(k) clearance)
Distal Head Image Quality Evaluation	Non-impairment of the image quality of the sigmoidoscope's distal head. (Implicit, based on functional test)	Performed (Specific results not detailed, but implied to be acceptable for 510(k) clearance)
Microbial Barrier Testing (using Phi X 174 bacteriophage)	Effective barrier against microbial penetration for sterile protection.	Presented in support of proposed label claims. (Specific quantitative results not detailed, but implied to be acceptable for 510(k) clearance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text. The tests mentioned are in vitro functional tests and microbial barrier testing, not tests on a clinical patient sample or data set.
Data Provenance: Not applicable, as these were in vitro laboratory tests, not human data.

3. 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. The ground truth for these in vitro physical and microbial barrier tests would be established by laboratory testing protocols and established scientific methods, not by expert human interpretation of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based studies where human interpretation is involved. This document describes in vitro functional and barrier tests.

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

No. An MRMC comparative effectiveness study was not done. This device is a physical sterile sheath, not an AI or diagnostic tool designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed (tensile/elongation, image quality, microbial barrier) would be established by physical standards and microbiological testing protocols. For example, the ground truth for microbial barrier testing would be the absence of bacteriophage penetration under specified conditions. This is not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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K964100 8172

DEC I 6 1996

Vision Sciences Inc. 510(k) Premarket Notification Modified EndoSheath® for VSI Flexible Sigmoidoscopes October 10, 1996

510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." VSI chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name:	EndoSheath® for use with the Vision-Sciences Model S-F100 and S-V100 Sigmoidoscopes
Owner/Operator:	Vision-Sciences, Inc.6 Strathmore Rd.Natick, MA 01760
Manufacturing Site:	Vision-Sciences, Inc.6 Strathmore Rd.Natick, MA 01760Reg. # 1223490
Device Generic Name:	Sigmoidoscope and accessories
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II,Performance Standards (CFR 874.4760).
Predicate Devices:	SS-V32 EndoSheath for use with the VSI S-V100 Sigmoidoscope (K932843)SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690)EndoSheath for use with the VSI C-F100 Colonoscope (K943895)EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591)EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809)

Manufactured and Distributed by:

Vision-Sciences, Inc.

6 Strathmore Rd.

Natick, MA 01760#### Product Description:

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K964100

p2072

Vision Sciences Inc. 510(k) Premarket Notification Modified EndoSheath® for VSI Flexible Sigmoidoscopes October 10, 1996

Indications for Use:

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

Safety and Performance:

The following in vitro functional tests were performed on the proposed EndoSheath:

1. Air/Water Tubing Tensile/Elongation Test
1. Distal Head Image Quality Evaluation

Microbial barrier testing using the Phi X 174 bacteriophage was also presented in support of the proposed label claims.

Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the EndoSheath for use with the VSI Model S-F100 and S-V100 Sigmoidoscopes has been shown to be safe and effective for its intended use.

Regulation Number and Section

§ 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.