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The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.

The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract. There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.

This document is a 510(k) summary for a medical device (Single-Use Flexible Rhinolaryngoscope) and primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. It explicitly states that no re-review of the 510(k) submission was done for the administrative correction. Therefore, the provided text does NOT contain information regarding acceptance criteria or a study proving that the device meets acceptance criteria related to AI or algorithm performance.

The document details the device's technical specifications and compares them to a predicate device, along with non-clinical tests (biocompatibility, electrical safety, EMC, and general performance testing) that are standard for medical devices of this type to ensure safety and effectiveness. It does not describe any studies involving algorithms, AI, or human reader performance.

Therefore, I cannot provide the requested information based on the provided text, as it does not address AI/algorithm performance. The information requested (multi-reader multi-case studies, standalone algorithm performance, ground truth establishment, sample sizes for training/test sets in the context of AI) is not present in this regulatory submission document about a rhinolaryngoscope.

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The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.

The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope.

The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device.

The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use 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 Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ 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.

The Veran SPiN Vision™ 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
• Working channel
• Sterilized by Ethylene Oxide
• For single use

The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow:

• Working channel diameters
• Insertion tube outer diameter

The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics:

• Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation
• Can connect to an external monitor
• Reusable device

This document is a 510(k) Summary for the Veran SPiN Vision™ Bronchoscope System, which makes a claim of substantial equivalence to a predicate device. It does not contain the detailed acceptance criteria, device performance reports, or study methodologies typically associated with proving a device meets acceptance criteria through a standalone study or multi-reader multi-case comparative effectiveness study.

Therefore, many of the requested details cannot be extracted from this document, particularly those related to a standalone algorithm performance, MRMC studies, or robust data provenance for AI/algorithm-based performance claims.

Here's what can be extracted based on the provided text:

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

The document lists performance tests conducted, but does not provide specific acceptance criteria or quantitative performance results for comparison. It only states, "All tests passed."

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

This information is not provided in the document. The performance data mentioned are for non-clinical bench testing, not clinical test sets or patient 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)

This information is not applicable as the document describes non-clinical bench testing, not a clinical study involving experts establishing ground truth from patient data.

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

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring adjudication of findings.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device is a bronchoscope system, not an AI or imaging diagnostic algorithm designed to assist human readers in interpretation.

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

A standalone performance study of an algorithm was not done or described. This submission is for a medical device (bronchoscope system) and its accessories, not a standalone algorithm.

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

The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, and internal specifications) against which the device's physical and electrical performance was measured. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.

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

This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.

Summary of available information:

The provided document is a 510(k) summary for the Veran SPiN Vision™ Bronchoscope System, focusing on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not include details on clinical studies, AI algorithm performance, or human reader studies, which are typically where detailed acceptance criteria and performance metrics for AI-based medical devices are presented. The performance data provided relates to the physical, electrical, and sterile properties of the bronchoscope system itself.

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