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The Vista Visualization System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures

The Vista Visualization System is 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 bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.

I am sorry. The provided text describes a 510(k) summary for a medical device called the Vista Visualization System. This document focuses on the device's intended use, description, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures

The Vista StereoScope 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. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.

The provided document appears to be an FDA 510(k) clearance letter and summary for a medical device called the "Vista Stereoscope System". This document establishes substantial equivalence to a predicate device, which is a regulatory pathway to market a new device by demonstrating it is as safe and effective as an already legally marketed device.

However, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way robust medical device studies (like those for AI/ML devices) typically do. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on intended use, operating principle, basic design, and shelf life.

Here's why the requested information cannot be fully provided from this document:

• No specific acceptance criteria: The document does not define quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other benchmark thresholds) that the device must meet.
• No detailed study results: It states that "Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness," but it does not provide details of such testing, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
• Not an AI/ML device: The "Vista Stereoscope System" appears to be a hardware device (camera head, endoscope, 3D camera control unit) for visualization, not an AI/ML software device that would typically undergo studies to compare its diagnostic performance against a ground truth.

Therefore, many of the requested fields are not applicable or cannot be answered from the provided text.

Here is an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method

• Adjudication method: Not specified.

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

• MRMC study done? No, this is not an AI-assisted device. The document is for a stereoscope system, which is a visualization tool, not an AI diagnostic/assistance tool.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable, as this is not an algorithm/AI device.

7. The type of ground truth used

• Type of ground truth: Not specified. Given it's a visualization device, "ground truth" in the diagnostic sense is less relevant than verification of image quality, functionality, and safety compared to the predicate device.

8. The sample size for the training set

• Sample size: Not applicable, as this is not a machine learning/AI device requiring a training set.

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

• Ground truth establishment: Not applicable, as this is not a machine learning/AI device requiring a training set with established ground truth.

Summary Explanation:

The provided document is an FDA 510(k) clearance for a stereoscope system, which is an endoscopic visualization device. The regulatory pathway used here is "substantial equivalence" to a predicate device (Vista Stereoscope System K990635). This means the manufacturer demonstrated that their device is as safe and effective as the already-marketed predicate, primarily through comparability in intended use, operating principles, basic design, and a general statement about testing demonstrating no adverse effect on safety and effectiveness due to modifications.

This type of submission typically does not involve the detailed clinical performance studies, ground truth establishment, or expert reviews that are common for AI/ML-driven diagnostic devices. Therefore, the specific details requested regarding acceptance criteria, sample sizes, expert qualifications, and adjudication methods for performance studies are not present in this document.

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The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.

The Vista ORPC System with IntraOp software now features the capability to control the image display with auxiliary input devices such as a touchscreen, mouse/touchpad, and a remote keypad, as well as with voice control. Color, hue, contrast and brightness for the video sources are now adjusted via the auxilliary input devices. Another new feature of the device is the capability to capture intra-operative static images of what is being displayed on the HMD. The last captured image can be displayed to the HMD as a picture-in-picture for review. The captured images can also be exported to a CD data storage disk via a CD-RW device. The capture and display last capture functions can be operated via voice control or the auxilliary input devices. The export feature is controlled via mouse, or the touchscreen. The system also allows the VGA monitor to display what is being seen in the HMD or the user interface controls on the desktop.

This document describes the 510(k) notification for the Vista ORPC with Infomatix™ IntraOp Software. However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to its image display or software functionalities.

The performance data section (Page 2 of 2) explicitly states: "The Vista Head Mounted Display System was designed and will be tested in compliance with the requirements of the following standards." This indicates that compliance testing to safety and electromagnetic compatibility (EMC) standards was planned, but no results or specific acceptance criteria for these tests or for the device's functional performance are provided.

Therefore, I cannot populate the table or answer the specific questions below from the provided text.

Here's a breakdown of why the requested information cannot be extracted:

• No performance metrics or clinical study results: The document focuses on regulatory submission details, device description, and intended use, but lacks any performance data, such as accuracy, sensitivity, specificity, image quality metrics, or any clinical outcomes.
• Emphasis on safety and EMC standards: The performance data section only lists international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL2601-1) that the device will be tested against. This does not constitute specific acceptance criteria for image display or software functionality, nor does it present the results of such tests.

Based on the provided text, the following information cannot be extracted:

1. Table of acceptance criteria and reported device performance: This information is not present in the document. The document lists safety and EMC standards the device will be tested against, but provides no specific acceptance criteria for functionality or performance.
2. Sample size used for the test set and the data provenance: No test sets or study data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test sets or adjudication methods are mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone performance study for an algorithm is mentioned as the device is a display system, not an AI algorithm for diagnosis.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training sets are mentioned.
9. How the ground truth for the training set was established: No training sets or ground truth establishment are described.

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The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.

The Vista StereoScope 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. The system will be supplied as a Vista StereoScope Camera Head, Vista Stereo Endoscope and a 3D Camera Control Unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.

This 510(k) summary for the Vista StereoScope System focuses on its substantial equivalence to predicate devices based on intended use, method of operation, material, and design. It details the device's description and intended use and lists the safety standards it was designed to comply with. However, it does not contain a standalone study with acceptance criteria and reported device performance in the way a clinical performance study would.

Therefore, for the specific request, much of the information regarding a performance study, acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not present in the provided document.

Here's a breakdown of what can and cannot be extracted:

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

• Not provided. The document states "The Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards," and then lists several IEC, UL, and ISO standards. This indicates safety and general performance compliance but does not provide specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics from a study comparing it to a ground truth or a clinical outcome.

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

• Not provided. No performance study or test set is described.

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 provided. No performance study and thus no ground truth establishment process is described.

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

• Not provided. No performance study and thus no adjudication method is described.

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 provided. This device is a video endoscope system, not an AI-assisted diagnostic tool.

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

• Not provided. This is a hardware device; a standalone algorithm performance study is not applicable.

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

• Not provided. No performance study implies no ground truth establishment for a clinical or diagnostic outcome.

8. The sample size for the training set:

• Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.

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

• Not applicable / Not provided. A training set is relevant for machine learning algorithms, which this device is not.

Summary of what the document does state regarding performance/testing:

The document indicates that the Vista StereoScope System was designed and will be tested in compliance with the requirements of the following standards:

• IEC 601-1: General Safety Requirements for Medical Electronic Equipment
• IEC 601-1-2: Electromagnetic Compatibility Requirements and Tests
• IEC 601-2-18: Safety of Endoscopic Equipment
• UL 2601-1: Standard for Safety, Medical Electrical Equipment, Part 1: General Requirements for Safety
• ISO 10993: Biological Evaluation of Medical Devices

This means the device's acceptance is primarily based on meeting these fundamental safety and electrical standards, rather than a clinical performance study with specific quantitative metrics. The 510(k) process for this device relies on substantial equivalence to predicate devices, implying that if the predicates were deemed safe and effective, and the new device poses no new safety or effectiveness concerns, it also can be marketed.

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

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Vista Head Mounted Display System". This type of document indicates regulatory clearance for a device based on substantial equivalence to a predicate device already on the market.

Crucially, this document does not contain the kind of detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, or ground truth methodologies that your request asks for.

The 510(k) clearance process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparative performance against the predicate, but the detailed study methodology and results (especially for AI-based performance metrics) are not usually included in the public-facing clearance letter.

Therefore, I cannot provide the requested information from the provided text. The document is too high-level and does not delve into the specifics of a performance study proving acceptance criteria for an AI device.

To answer your questions, I would need a different type of document, such as a detailed study report, a clinical trial summary, or a more comprehensive technical submission.

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The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.

The Vista Single Chip Video Camera 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. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.

The provided text describes a 510(k) submission for the Vista Single Chip Video Camera System. It outlines the device's intended use, predicate devices, and compliance with safety standards. However, it does not contain the detailed performance data, acceptance criteria, or study descriptions needed to fully answer your request regarding acceptance criteria and a study proving device conformance.

The "PERFORMANCE DATA" section only lists the standards the device was designed to comply with (IEC 601-1, IEC 601-1-2, UL544) and mentions "Optical Test Data" without providing any details about the tests, their results, or acceptance criteria.

Therefore, for most of your questions, the answer will be that the information is not provided in the given text.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided.

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

• Number of Experts: Not applicable/not provided. This type of device (a video camera) typically relies on objective performance measurements rather than expert consensus on medical image interpretation for its primary safety and effectiveness evaluation for 510(k) purposes.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC study was not described or implied. This type of study is more relevant for diagnostic AI algorithms rather than a medical imaging device itself.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Performance Study: Not described in the text. The "Optical Test Data" mentioned could refer to some form of standalone performance, but no details are given. The device is a video camera, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. For a video camera, "ground truth" would likely relate to objective optical and electrical performance characteristics measured against engineering specifications, rather than medical interpretations.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is a hardware video camera, not an AI algorithm that undergoes "training."

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

• Ground Truth for Training Set: Not applicable. The concept of a "training set" and "ground truth" for training does not apply to this type of device.

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The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps age. "It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.

The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc.

The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life.

The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet.

Since the provided text describes a 510(k) notification for an illumination system, the "acceptance criteria" and "device performance" are typically related to meeting established electrical safety and electromagnetic compatibility standards, rather than clinical performance metrics found in AI/ML device studies. The document does not provide details of a clinical study as would be expected for AI/ML devices. Therefore, many of the requested fields cannot be filled.

Here's an interpretation based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable. This is not a clinical study involving a test set of data. The performance relates to compliance with electrical and safety standards for the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a clinical study involving ground truth established by experts. Compliance with standards is typically assessed through engineering tests and adherence to specified design and manufacturing protocols.

4. Adjudication method for the test set
Not applicable.

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 device is not an AI/ML device and human reader performance is not relevant to its safety and effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
Not applicable. The "ground truth" for this device's performance is adherence to established electrical safety and electromagnetic compatibility standards, demonstrated through testing against those standards.

8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document indicates that the Vista Illumination System meets its acceptance criteria by complying with several international and national standards for medical electrical equipment. These standards cover general safety requirements (IEC 601-1), electromagnetic compatibility (IEC 601-1-2), and safety specifically for medical and dental equipment (UL 544).

The "study" in this context refers to the engineering and testing processes that demonstrate the device's adherence to these published standards. These typically involve:

• Design and manufacturing controls: Ensuring the device is designed and built according to the specifications outlined in the standards.
• Bench testing: Performing specific electrical, mechanical, and environmental tests as mandated by each standard. This would include tests for electrical current leakage, insulation, temperature rise, mechanical stability, electromagnetic emissions, and immunity to electromagnetic interference.
• Documentation: Providing evidence (test reports, certifications) that the device has undergone and passed the required tests.

The 510(k) submission process relies on demonstrating substantial equivalence to a predicate device (Cogent Light Illuminator 10010 Xenon Light Source and Fiberoptic Cable, K933405) and showing that the new device meets recognized safety and performance standards. The listed standards are the key "acceptance criteria" and compliance with them is the "proof" the device meets these criteria for regulatory clearance.

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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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