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The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures

The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.

The provided document appears to be an FDA 510(k) clearance letter and summary for a medical device called the "Vista Stereoscope System". This document establishes substantial equivalence to a predicate device, which is a regulatory pathway to market a new device by demonstrating it is as safe and effective as an already legally marketed device.

However, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way robust medical device studies (like those for AI/ML devices) typically do. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on intended use, operating principle, basic design, and shelf life.

Here's why the requested information cannot be fully provided from this document:

• No specific acceptance criteria: The document does not define quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other benchmark thresholds) that the device must meet.
• No detailed study results: It states that "Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness," but it does not provide details of such testing, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
• Not an AI/ML device: The "Vista Stereoscope System" appears to be a hardware device (camera head, endoscope, 3D camera control unit) for visualization, not an AI/ML software device that would typically undergo studies to compare its diagnostic performance against a ground truth.

Therefore, many of the requested fields are not applicable or cannot be answered from the provided text.

Here is an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method

• Adjudication method: Not specified.

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

• MRMC study done? No, this is not an AI-assisted device. The document is for a stereoscope system, which is a visualization tool, not an AI diagnostic/assistance tool.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable, as this is not an algorithm/AI device.

7. The type of ground truth used

• Type of ground truth: Not specified. Given it's a visualization device, "ground truth" in the diagnostic sense is less relevant than verification of image quality, functionality, and safety compared to the predicate device.

8. The sample size for the training set

• Sample size: Not applicable, as this is not a machine learning/AI device requiring a training set.

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

• Ground truth establishment: Not applicable, as this is not a machine learning/AI device requiring a training set with established ground truth.

Summary Explanation:

The provided document is an FDA 510(k) clearance for a stereoscope system, which is an endoscopic visualization device. The regulatory pathway used here is "substantial equivalence" to a predicate device (Vista Stereoscope System K990635). This means the manufacturer demonstrated that their device is as safe and effective as the already-marketed predicate, primarily through comparability in intended use, operating principles, basic design, and a general statement about testing demonstrating no adverse effect on safety and effectiveness due to modifications.

This type of submission typically does not involve the detailed clinical performance studies, ground truth establishment, or expert reviews that are common for AI/ML-driven diagnostic devices. Therefore, the specific details requested regarding acceptance criteria, sample sizes, expert qualifications, and adjudication methods for performance studies are not present in this document.

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The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system will be supplied as a Vista StereoScope Camera Head, Vista Stereo Endoscope and a 3D Camera Control Unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.

This 510(k) summary for the Vista StereoScope System focuses on its substantial equivalence to predicate devices based on intended use, method of operation, material, and design. It details the device's description and intended use and lists the safety standards it was designed to comply with. However, it does not contain a standalone study with acceptance criteria and reported device performance in the way a clinical performance study would.

Therefore, for the specific request, much of the information regarding a performance study, acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not present in the provided document.

Here's a breakdown of what can and cannot be extracted:

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

• Not provided. The document states "The Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards," and then lists several IEC, UL, and ISO standards. This indicates safety and general performance compliance but does not provide specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics from a study comparing it to a ground truth or a clinical outcome.

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

• Not provided. No performance study or test set is described.

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):

• Not provided. No performance study and thus no ground truth establishment process is described.

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

• Not provided. No performance study and thus no adjudication method 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 provided. This device is a video endoscope system, not an AI-assisted diagnostic tool.

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

• Not provided. This is a hardware device; a standalone algorithm performance study is not applicable.

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

• Not provided. No performance study implies no ground truth establishment for a clinical or diagnostic outcome.

8. The sample size for the training set:

• Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.

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

• Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.

Summary of what the document does state regarding performance/testing:

The document indicates that the Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards:

• IEC 601-1: General Safety Requirements for Medical Electronic Equipment
• IEC 601-1-2: Electromagnetic Compatibility Requirements and Tests
• IEC 601-2-18: Safety of Endoscopic Equipment
• UL 2601-1: Standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety
• ISO 10993: Biological Evaluation of Medical Devices

This means the device's acceptance is primarily based on meeting these fundamental safety and electrical standards, rather than a clinical performance study with specific quantitative metrics. The 510(k) process for this device relies on substantial equivalence to predicate devices, implying that if the predicates were deemed safe and effective, and the new device poses no new safety or effectiveness concerns, it also can be marketed.

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