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The VISTA™ Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

The VISTA Endoscope is a flexible fiberscope that allows for visualization of the thoracic and abdominal cavities. The device is labeled non-sterile and must be sterilized prior to use. The Endoscope may be used with or without the SCOUTTM Blunt-tipped Guide accessory, which aids in Endoscope advancement and steerability. The Guide also has a fluid channel (cannula) that may be used to deliver saline that may be required for irrigation during an endoscopic procedure. The SCOUTTM Guide is a sterile, single-use device, sterilized by electron beam radiation.

The provided document describes a 510(k) premarket notification for the VISTA™ Endoscope and Accessories. It outlines the device's description, indications for use, and a comparison of its technological characteristics with predicate devices. The "Performance Data" section briefly mentions that "Laboratory and performance tests were executed to ensure that the devices functioned as intended and met design specifications" and "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria." However, it does not provide specific details about the acceptance criteria nor the study design, sample sizes, expert qualifications, or ground truth establishment for those performance tests.

Therefore, I can only provide the information that is present in the document.

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

The document states: "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria."

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 states: "Laboratory and performance tests were executed".

• Sample size: Not specified.
• Data provenance: Not specified. It's implied to be laboratory testing, but no details on the origin of the data or whether it was retrospective or prospective are provided.

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 specified. The document refers to "performance tests" and "design specifications" but does not mention the involvement of experts to establish a "ground truth" in the context of clinical or diagnostic performance. This is typically a technical performance study, not a clinical diagnostic study with expert review.

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

Not applicable/Not specified. This type of adjudication method is relevant for studies involving human interpretation of data, which is not described here.

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 describes a medical device (endoscope), not an AI-assisted diagnostic tool.

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

Not applicable. This document describes a medical device (endoscope), not an algorithm.

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

Not explicitly stated using the term "ground truth." For the performance tests, the "ground truth" would be the engineering specifications and standards that the device was designed to meet (e.g., optical properties, flexibility, material biocompatibility, sterility).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a training set.

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

Not applicable. This document describes a medical device, not a machine learning model.

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