The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.

Device Description

The VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath consists of a reusable bronchoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the suction/biopsy channel. The sheath is removed and disposed of following each procedure.

AI/ML Overview

The provided text describes Vision Sciences Inc.'s 510(k) Premarket Notification for their Flexible Fiberoptic Bronchoscope with Disposable EndoSheath. However, it does not include detailed acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically required for a comprehensive AI/ML device submission as outlined in your request.

The submission is for a physical medical device (a bronchoscope and sheath) and focuses on functional, biocompatibility, and microbial barrier testing, rather than an AI/ML algorithm's performance. Therefore, I cannot extract the specific information you've requested about AI/ML device performance, such as sensitivity, specificity, MRMC studies, effect sizes of AI assistance, or details about training/test set ground truth establishment for an AI algorithm.

Based on the provided text, here is what can be inferred relating to acceptance criteria and performance, but it focuses on the device's physical and functional aspects, not AI/ML performance:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (as described in the document)
Functional Tests	- System Functional Testing: Performed. (Implicitly, the device passed these tests, leading to the conclusion of safety and effectiveness.)
	- System Cycle Testing: Performed. (Implicitly, the device passed these tests, indicating durability and reliability over multiple uses/cycles.)
	- Sheath Burst Testing: Performed. (Implicitly, the sheath demonstrated sufficient strength and integrity under pressure, preventing rupture during use.)
Biocompatibility	- Irritation: Data presented. (Implicitly, the device materials are non-irritating.)
	- Sensitization: Data presented. (Implicitly, the device materials do not cause allergic reactions.)
	- Cytotoxicity: Data presented. (Implicitly, the device materials are not toxic to cells.)
	- Acute Systemic Toxicity: Data presented. (Implicitly, the device materials do not cause acute systemic toxic effects.)
Microbial Barrier	- Microbial barrier testing: Included. (Implicitly, the disposable sheath effectively prevents microbial ingress, ensuring patient safety.)
Overall Conclusion	- "Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath has been shown to be safe and effective for its intended use."

The following points cannot be answered based on the provided text, as they pertain to AI/ML device evaluation, which is not described in this 510(k) summary for a physical bronchoscope:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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L963795

DEC 2 3 1996

Vician Sciences In 510(k) Premarket Notification Flexible Fiberoptic Bronchoscope with D

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:
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VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath

Owner/Operator:

Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760

Manufacturing Site:

EndoSheath: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 Reg. # 1223490

Endoscope:

Vision-Sciences, Inc. 40 Ramland Rd. South Orangeburg, NY 10962 Reg. #2242464

Device Generic Name: Bronchoscope and accessories

Classification:

According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 874.4680).

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ision Sciences Inc 510(k) Premarket Notification Flexible Fiberoptic Bronchoscope with Disposable EndoSheath® September 20, 1996

Predicate Devices:

Model BF-3C20 Bronchoscope

Manufactured and Distributed by: Olympus Corp. 4 Nevada Dr. Lake Success, NY 11042

1. Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope
  Manufactured and Distributed by: Pentax Precision Instrument Corp. 30 Ramland Road. Orangeburg, NY 10962
Model SF-100 Flexible Fiberoptic Sigmoidoscope and Disposable 3. EndoSheath (K921690)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
Model SV-100 Flexible Video Sigmoidoscope and Disposable 4. EndoSheath (K932843)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760

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ર. Protective Sheath for use with the VSI Model E-F100 ENT endoscope (K961591)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
Protective Sheath for use with the Machida Models ENT-3L and ENT-4L, 6. Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K950809)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760

Product Description:

Vision Sciences Inc.

510(k) Premarket Notification

Indications for Use:

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Vision Sciences Inc. 510(k) Premarket Notification

Safety and Performance:

The following in vitro functional tests were performed on the proposed VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath:

1. System Functional Testing
1. System Cycle Testing
1. Sheath Burst Testing

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

1. Irritation
1. Sensitization
1. Cytotoxicity
1. Acute Systemic Toxicity

Microbial barrier testing was also included.

Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath has been shown to be safe and effective for its intended use.

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Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.