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

The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista camera control unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vista Mini Camera System:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating compliance with established safety and electromagnetic compatibility (EMC) standards. It does not provide specific performance metrics (e.g., resolution, field of view, illumination intensity) that are typically associated with "acceptance criteria" for image quality or clinical efficacy in the way modern AI/ML devices do.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of this device and study. The document describes compliance with standards (safety, EMC, biocompatibility) through design and testing. It doesn't involve a "test set" of medical images or patient data to evaluate algorithmic performance.
• Data Provenance: Not applicable. The testing relates to engineering and material properties, not medical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The ground truth for compliance with safety and EMC standards is established by the specifications within those standards, and testing is performed by engineers/technicians according to defined protocols, often by accredited testing labs. There's no "ground truth" derived from expert medical review for performance claims in this document.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" of medical cases requiring adjudication. Compliance with standards is typically confirmed through objective measurements and verification against specified criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) summary.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not performed. This device is a camera system, not an AI or algorithmic diagnostic tool.

7. Type of Ground Truth Used:

• The "ground truth" for the device's acceptable performance is defined by the requirements and specifications within the cited industry and safety standards (IEC 601-1, IEC 601-1-2, IEC 601-2-18, ISO 10993, UL544). These standards specify acceptable levels for electrical current leakage, electromagnetic emissions/immunity, biocompatibility, and mechanical safety, among others.

8. Sample Size for the Training Set:

• Not applicable. This device is a hardware camera system, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for this type of device.

Summary of the Study and Device Purpose:

This 1997 510(k) submission for the Vista Mini Camera System focuses entirely on demonstrating the device's safety and effectiveness by showing compliance with well-established international and national standards for medical electrical equipment, endoscopic equipment, and biocompatibility. The "study" described is a series of engineering tests and evaluations against these technical standards. It is crucial to understand that this submission predates the widespread use of AI/ML in medical devices, and therefore, the document does not contain the types of performance metrics or study designs (e.g., MRMC, standalone algorithm performance, clinical ground truth from experts) that would be expected for a modern AI-powered diagnostic or assistive tool. The acceptance criteria are primarily related to the physical and electrical integrity and safety of the device for its intended use.

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