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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 Vista Head Mounted Display System is designed to display video images while mounted on the users head.

The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment.

The HMD consists of an image generating array, evepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes.

The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.

The provided text describes a medical device, the "Head Mounted Display (HMD)", and its intended use, but it does not include information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot populate the table or answer most of the questions you've posed. The 510(k) summary focuses on device description, intended use, and comparison to predicate devices for regulatory clearance, not on performance studies with defined acceptance criteria.

Here's what I can extract based on the provided text, and what remains unanswered:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not provided. The document does not mention any test set, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. The document does not mention any expert review or ground truth establishment for a test set.

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

• Not applicable/Not provided. No test set or adjudication method is mentioned.

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:

• No. The Head Mounted Display is a hardware component for visualization. It is not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• No. This is a hardware device, not a standalone algorithm.

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

• Not provided. No performance studies or ground truth establishment are described.

8. The sample size for the training set:

• Not applicable/Not provided. The device is hardware; there is no mention of a training set for an algorithm.

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

• Not applicable/Not provided. There is no mention of a training set or its ground truth.

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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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