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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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