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The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.

AI/ML Overview

The provided document is a 510(k) summary for the KSEA Fiberscope, a medical device for visualization during endoscopic heart surgery. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in this type of regulatory submission.

Here's an analysis based on the available information, noting what cannot be extracted from this document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or quantitative performance metrics in the way a study for an AI/ML device would. For 510(k) submissions, the acceptance criteria are generally met by demonstrating that the new device has "substantially equivalent" features, design, body contact material, and general intended uses to legally marketed predicate devices, and that it does not raise new safety or effectiveness issues.

Acceptance Criteria Category	Reported Device Performance (as per document)
Basic Features	Substantially equivalent to predicate devices
Design	Substantially equivalent to predicate devices
Body Contact Material	Substantially equivalent to predicate devices
General Intended Uses	Substantially equivalent to predicate devices
Safety Concerns	Does not incorporate any significant change that could affect safety or effectiveness; minor differences raise no new issues of safety and effectiveness; design differences have no affect on performance, function, or intended use.

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

Not applicable. This is a 510(k) summary demonstrating substantial equivalence, not a study evaluating performance on a specific test set of data. It describes the device itself and its equivalence to others.

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

Not applicable. No "ground truth" establishment in the context of a data-driven test set is described here. The evaluation is based on comparing device specifications and intended use against predicate devices.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

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 document is for a fiberscope, a manually operated surgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The ground truth for this type of submission is the regulatory knowledge and performance history of the predicate devices. The device's "truth" is its ability to visualize as intended, which is assumed to be similar to its predicates.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed with a training set.

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

Not applicable. This device is not an AI/ML product requiring a training set with established ground truth.

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