The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.

Device Description

The VSI EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope 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

This looks like a 510(k) summary for a medical device, specifically an EndoSheath for a nasopharyngoscope. This type of document generally focuses on demonstrating substantial equivalence to a predicate device through performance testing and does not typically involve the kinds of studies (e.g., studies with human readers, ground truth consensus panels) that are common for AI/ML-based diagnostic devices.

Therefore, many of the requested fields cannot be directly answered from the provided text as they are not applicable to this type of device and submission.

Here's an analysis based on the provided text, addressing what can be extracted and noting what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Functional and Burst Test", "Scope Angulation", etc., as tests performed, implying these are the areas where the device needs to perform adequately. However, specific quantitative acceptance criteria (e.g., "burst pressure must be > X psi") and the corresponding quantitative performance results were not provided in the summary. The summary only states that these tests were performed and implies satisfactory results based on the "Conclusion" statement.

Test Performed	Acceptance Criteria (Not Explicitly Stated Quantitatively in Summary)	Reported Device Performance (No Quantitative Data Provided)
Functional and Burst Test	Implied to meet functional/burst requirements	Implied acceptable
Scope Angulation (With and Without Sheath)	Implied that sheath does not unduly impede angulation	Implied acceptable
Scope OD (With and Without Sheath)	Implied that sheath does not unduly increase OD	Implied acceptable
Sheath Longitudinal and Radial Strain when Loaded on Scope	Implied that sheath withstands strain without failure	Implied acceptable
Light Transmittance	Implied adequate light transmission for visualization	Implied acceptable
Field of View	Implied that sheath does not unduly obstruct field of view	Implied acceptable
Scope Resolution (With and Without Sheath)	Implied that sheath does not unduly degrade resolution	Implied acceptable
Biocompatibility Tests:
Irritation	Implied to be non-irritating	Implied acceptable
Sensitization	Implied to be non-sensitizing	Implied acceptable
Cytotoxicity	Implied to be non-cytotoxic	Implied acceptable
Acute Systemic Toxicity	Implied to be non-toxic systemically	Implied acceptable
Hemolysis	Implied to cause no undue hemolysis	Implied acceptable
Implantation	Implied to be suitable for contact without adverse effects	Implied acceptable
Microbial Barrier Testing:
Live Polio Virus	Implied to be an effective barrier against virus	Implied acceptable
Phi X 174 Bacteriophage	Implied to be an effective barrier against bacteriophage	Implied acceptable

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

Sample Size for Test Set: Not specified. The document only lists the types of tests performed ("in vitro functional tests," "biocompatibility data," "microbial barrier testing"). It does not mention the number of units or samples tested for each.
Data Provenance: Not applicable. These are in-vitro, engineering, and laboratory tests on physical components, not clinical data from patients.

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

Not Applicable. This device is a physical sterile sheath. Ground truth establishment by clinical experts (like radiologists for imaging devices) is not relevant for its safety and performance claims outlined here. The tests are direct measurements of physical and biological properties.

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

Not Applicable. As there are no human-read interpretations or clinical assessments, an adjudication method for a test set is not relevant.

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 is not an AI/ML diagnostic device. It's a sterile, disposable protective sheath for an endoscope. No MRMC study involving human readers or AI assistance was performed or would be relevant.

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

Not Applicable. This is not an algorithm or AI device.

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

Not Applicable. Ground truth in the context of diagnostic performance (e.g., for AI) is not relevant here. The "ground truth" for the tests performed are the physical and chemical standards and methods used in laboratories (e.g., a burst test's "ground truth" is whether it burst at a certain pressure or not; a biocompatibility test's "ground truth" is whether a cytotoxic effect was observed).

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a "training set."

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

Not Applicable. No training set exists for this device.

Summary

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Vision Sciences, Inc. 510(k) Premarket Notification

April 22, 1996 EndoSheath® for E-F100 Nasopharyngoscope

K961591

Summary of Safety and Effectiveness

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-SciencesModel E-F100 Nasopharyngoscope
Owner/Operator:	Vision-Sciences, Inc.6 Strathmore Rd.Natick, MA 01760
Manufacturing Site:	Endosheath:Vision-Sciences, Inc.6 Strathmore Rd.Natick, MA 01760Reg. # 1223490
Device Generic Name:	Nasopharyngoscope 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:

EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247)

Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760

Product Description:

Indications for Use:

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.

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Safety and Performance:

The following in vitro functional tests were performed on the proposed Endosheath for use with the VSI Model E-F100 Nasopharyngoscope:

1. Functional and Burst Test
Scope Angulation (With and Without Sheath) 2.
Scope OD (With and Without Sheath) 3.
Sheath Longitudinal and Radial Strain when Loaded on Scope 4.
న. Light Transmittance
Field of View 6.
Scope Resolution (With and Without Sheath) 7.

The following biocompatibility data was presented in support of this Premarket Notification:

1. Irritation
1. Sensitization
1. Cytotoxicity
1. Acute Systemic Toxicity
ડ. Hemolysis
ર્. Implantation

Microbial barrier testing using live polio virus as well as 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 E-F100 Nasopharyngoscope has been shown to be safe and effective for its intended use.

0.226

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.