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The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

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The provided text is an FDA 510(k) clearance letter for the Vathin Video Bronchoscope System. It does not contain any information about acceptance criteria, device performance studies, or details regarding AI algorithms.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this data is not present in the given document.

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The Vathin®H-SteriScopeTM I Single-use flexible Video Bronchoscope have been designed to be used with the Vathin@VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope (eighteen models shown in below) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenter™ I Digital Video Processor (model: DVP-A1) for clinical image processing. The Vathin®H-SteriScope™ I Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCenter™ I Digital Video Processor provides power and processes the images for medical electronic endoscope.

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope is a sterile single used flexible bronchoscope. Vathin®VisionCenter™ I Digital Video Processor is a reusable monitor.

The light emitted by the LED cold light source of the Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Vathin®VisionCenter™ I Digital Video Processor via the encoding circuit. The Vathin®VisionCenter™ I Digital Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

The differences between the Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope models are as follow:

• Presence or absence of working channel
• Working channel inner diameter
• Insertion tube outer diameter
• The length of insertion tube

Vathin®VisionCenter™ I Digital Video Processor has the following physical and performance characteristics:

• Provide image from Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope for observation
• Can connect to an external monitor
• Reusable device

This document describes the regulatory approval for the Vathin® Video Bronchoscope System. However, it does not contain a study that establishes acceptance criteria for direct device performance in a clinical context, nor does it provide details of a study specifically designed to prove the device meets such criteria.
The provided text focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 3 System) through non-clinical performance data and adherence to recognized standards.

Here's an analysis of the requested information based on the provided text:

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

The document presents a comparison table (Page 6-7) of technological characteristics between the subject device (Vathin® Video Bronchoscope System) and the predicate device (Ambu® aScope™ 3 System). While these are not explicitly termed "acceptance criteria" in the context of a clinical performance study, they represent the design and performance specifications against which the device was evaluated for substantial equivalence. The "Remark" column indicates how the subject device's performance compares to the predicate.

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

The document explicitly states: "no clinical studies were needed to support this 510(k) Premarket Notification." This means there was no designated "test set" in the context of a clinical trial or performance study involving human patients. The evaluation was based on non-clinical bench testing and comparison to the predicate device's specifications. Thus, there is no sample size for a test set, nor a data provenance in terms of country or retrospective/prospective nature.

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)

Since no clinical studies were performed, there was no "ground truth" established by experts in a clinical setting for the purpose of validating the device's diagnostic or procedural effectiveness on human patients. The assessment relied on engineering and performance criteria established through bench testing and comparative analysis against the predicate device and relevant standards.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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 device is a bronchoscope system, not an AI-powered diagnostic tool, and no MRMC studies were conducted.

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

Not applicable. This is a medical instrument, not a standalone algorithm.

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

For the non-clinical bench testing, the "ground truth" was established by engineering specifications, recognized international standards (e.g., ISO 8600, ISO 80369-7, IEC 60601 series, ISO 11135), and the performance characteristics of the legally marketed predicate device. The product's compliance with these standards and equivalence to the predicate serve as the basis for its safety and effectiveness claims.

8. The sample size for the training set

Not applicable. This device does not have an AI component that undergoes a training phase with a dataset.

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

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

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