The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure.

AI/ML Overview

The provided text describes a 510(k) summary for the Vision-Sciences Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath. However, it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document focuses on device description, indications for use, and a brief mention of two performance tests. It explicitly states that no biocompatibility data was presented. More importantly, it does not provide any specific acceptance criteria (e.g., numerical thresholds for resolution or angulation) nor does it report the actual device performance metrics against such criteria.

Therefore, I can only provide information based on what is available in the text.

Here's the information that can be extracted or inferred, and the parts that cannot be answered from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Required for Approval)	Reported Device Performance (Achieved)
Scope Angulation/Cycle Testing: No specific numerical acceptance criteria are provided in the document.	The document states "Performance testing was presented in support of this submission" for "Scope Angulation/Cycle Testing (with and without EndoSheath)." However, no numerical results or a statement of meeting an unstated criterion are provided. It only implies the test was performed.
Scope Resolution: No specific numerical acceptance criteria are provided in the document.	The document states "Performance testing was presented in support of this submission" for "Scope Resolution (with and without EndoSheath)." However, no numerical results or a statement of meeting an unstated criterion are provided. It only implies the test was performed.
Biocompatibility: No specific acceptance criteria are mentioned, but implicitly, a device intended for internal use would typically require biocompatibility.	The document explicitly states: "No biocompatibility data was presented in support of this Premarket Notification." This indicates that while it might be an implicit criterion for such a device, no data was provided in this submission to address it.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the tests mentioned (Angulation/Cycle Testing, Resolution).
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: The performance tests mentioned (Angulation/Cycle Testing, Resolution) are objective engineering/physical performance tests of the device itself, not diagnostic performance tests involving human interpretation or clinical data. Therefore, "ground truth" in the clinical diagnostic sense with expert consensus is not relevant for these specific tests.

4. Adjudication method for the test set

Not Applicable: As explained above, these were physical device performance tests, not clinical diagnostic studies requiring adjudication of output.

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: The document does not mention any MRMC study. The device is a sigmoidoscope, which is an optical instrument for direct examination, not an AI-powered diagnostic tool.

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

Not Applicable: The device described is a physical instrument (sigmoidoscope), not a standalone algorithm.

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

Not Applicable in the clinical sense: For the Angulation/Cycle and Resolution tests, the "ground truth" would be established by validated engineering standards and measurement equipment. The document does not detail these standards or measurements.

8. The sample size for the training set

Not Applicable: This is a physical device, and the mentioned tests are physical performance validations, not related to machine learning models that require training sets.

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

Not Applicable: As above, this information is irrelevant for the type of device and tests described.

Summary of Limitations from the Provided Text:

The provided 510(k) summary is very high-level regarding performance testing. It indicates that tests were performed ("Scope Angulation/Cycle Testing" and "Scope Resolution"), but it lacks crucial details such as:

Specific numerical acceptance criteria.
The actual quantitative results of these tests.
The methodology of these tests (e.g., how resolution was measured, how many cycles were performed).
Sample sizes for these tests.
Any details about clinical performance, given that it focuses on physical characteristics.

Summary

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510(k) Summary

K964326
Jan 3, 1997

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	VSI Model S-V200 Color Video Sigmoidoscope with Disposable
Owner/Operator:	Vision-Sciences, Inc.6 Strathmore Rd.Natick, MA 01760
Manufacturing Site:	EndoSheath:Vision-Sciences, Inc6 Strathmore Rd.Natick, MA 01760Reg. # 1223490
	Endoscope:Vision-Sciences, Inc.40 Ramland Rd. SouthOrangeburg, NY 10962Reg. #2242464
Device Generic Name:	Sigmoidoscope and accessories
Classification:	According to Section 513 of the Federal Food, Drug, and Cosmetic Act, thedevice classification is Class II. Performance Standards (CFR 876.1500).

Predicate Devices:

Vision-Sciences Model S-V100 Video Sigmoidoscope with SS-V32 EndoSheath System 1. (K932843)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
1. Model VS-200 Video Sigmoidoscope (KU54704)
  Manufactured and Distributed by Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153

00226

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Product Description:

Indications for Use:

Safety and Performance:

The following performance testing was presented in support of this submission:

Scope Angulation/Cycle Testing (with and without EndoSheath) 1.
1. Scope Resolution (with and without EndoSheath)

Performance testing for the I ndoSheath is contained in K % 4 (00)

No biocompatibility data was presented in support of this Premarket Notification.

Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath has been shown to be safe and effective for its intended use

000207

Jul

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.