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The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.

The 3D Video Endoscope 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, including general thoracic and as an aid in visualization of the evacuated cardiac chamber. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific imaging metrics) related to the "3D Video Endoscope". Instead, the "Performance Data" section lists compliance with a set of international and U.S. safety and compatibility standards.

Therefore, the table below reflects the stated performance criteria (standards compliance) and the implicit claim of meeting these standards for the device.

Study Information

Based on the provided K970214 510(k) Notification, the nature of the "study" conducted for this device is primarily focused on bench testing and compliance with recognized standards, rather than clinical performance (e.g., diagnostic accuracy, reader studies).

Here's a breakdown of the requested information, where available:

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

   • Sample Size: Not applicable in the context of a clinical test set. The testing involved compliance with various standards, which would typically involve testing of device units/components, not patient data sets.
   • Data Provenance: Not applicable. The "data" refers to engineering test results and compliance documentation, not patient data.

2. 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 applicable. Ground truth, in the sense of expert consensus on medical findings, is not mentioned as part of this submission. Compliance with standards is typically verified by engineers and quality assurance personnel against defined test protocols.

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

   • Not applicable. Adjudication methods are relevant for interpretation of clinical results, which are not described here.

4. 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:

   • No. The document presents a 510(k) for a 3D Video Endoscope. This device predates the widespread use of AI in medical imaging interpretation and does not involve AI assistance for human readers. No MRMC study is mentioned.

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

   • No. This device is a video endoscope, not an algorithm. Its function is to provide images for human interpretation and surgical guidance.

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

   • Not applicable in the clinical sense. The "ground truth" for the performance studies listed is adherence to the specifications within the cited safety, EMC, biocompatibility, and optical standards. For example, for an electrical safety test, the "ground truth" is that the device passes specific voltage, current, or insulation resistance thresholds as defined by IEC 601-1.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable. No training set is involved.

Summary of Device Evaluation Approach:

The 510(k) submission for the Vista Medical Technologies 3D Video Endoscope primarily demonstrates substantial equivalence to predicate devices and adherence to established electrical, safety, biocompatibility, and optical performance standards. The "study" data mentioned are technical compliance documents and test reports, not clinical trials or reader studies in the modern sense of demonstrating diagnostic accuracy or efficacy.

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