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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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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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The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures.

The provided text is a 510(k) summary for a medical device (3D SCOPE™) from 1996. It focuses on adding an indication for use ("examination of the evacuated cardiac chambers") to an already cleared device.

Crucially, the document explicitly states that "The device is not modified in any way except for the added indication for use." This implies that the device's performance, as proven by the original clearance (K923160), is considered sufficient for this new indication based on the device's established technological equivalency to its predicate.

Therefore, there is no new study described in this 510(k) summary demonstrating acceptance criteria for the new indication. The acceptance criteria and the study that proved them would have been part of the original 510(k) submission (K923160), which is not provided here.

Given the information provided, I cannot populate the requested table or answer most of the questions because the document does not describe a new study or new acceptance criteria for the device's performance related to its new indication. The clearance is based on the equivalency of the new indication to the previously cleared indications and the existing device's proven performance for those indications.

Here's what can be inferred or stated based on the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable. No new acceptance criteria or new performance data are presented for the added indication. The device's performance for general endoscopic and laparoscopic procedures was accepted in the original 510(k) (K923160).
2. Sample size used for the test set and the data provenance: Not applicable. No new test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set data is presented.
4. Adjudication method for the test set: Not applicable. No new test set data is presented.
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 is a 1996 device; AI assistance for visual medical devices in the context of MRMC studies was not a standard or relevant evaluation method at that time.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device; it's a visualization system for human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this 510(k) submission.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the modern sense.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The 510(k) submission is for an expanded indication for use of an already cleared and unmodified device. Therefore, no new performance studies, acceptance criteria, or ground truth establishment methods are described within this specific document. The justification for clearance relies on the established substantial equivalence and performance of the device under its original clearance (K923160).

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