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The system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and large joint arthroscopic procedures.

The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VS3-ETV device:

The provided text is a 510(k) summary for the VS3-ETV, which is a modified version of the predicate device, the VS3 Stereoscopic High Definition Vision System (K141002). This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for clinical outcomes.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this type of document because the submission strategy is based on comparing technological characteristics and non-clinical performance to a cleared predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially derived from the technological characteristics of the predicate device and the established recognized standards the device conforms to. The "reported device performance" are the stated characteristics of the proposed device, which are shown to be equivalent to the predicate.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission showing substantial equivalence, the "acceptance criteria" are not typically clinical performance metrics with target values (e.g., sensitivity, specificity). Instead, they are the demonstration that the modified device's technological characteristics and non-clinical performance (e.g., safety, sterilization) are either identical or equivalent to the predicate device, or that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "performance testing" mentioned refers to non-clinical tests like reuse validation, cleaning, disinfection, and sterilization. The sample size for these non-clinical tests (e.g., number of instruments tested for sterilization cycles) is not provided.
• Data Provenance: Not applicable as it's not a clinical study on patient data. The non-clinical tests were likely conducted by the manufacturer, Visionsense Ltd., in Israel or a contract testing lab.

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

• Number of Experts/Qualifications: Not applicable. There is no mention of a human-read clinical test set or ground truth established by experts in this 510(k) summary. The performance data presented are physical/technical specifications and results from non-clinical validation tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication 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

• MRMC Study / Effect Size: Not applicable. This device is an endoscope/vision system, not an AI diagnostic algorithm for image interpretation. There is no mention of AI assistance for human readers or an MRMC study.

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

• Standalone Performance: Not applicable. This is a hardware device (endoscope system), not a standalone algorithm.

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

• Ground Truth: Not applicable in the traditional sense of a diagnostic device. For the technical performance characteristics, the "ground truth" would be established by direct measurement with calibrated instruments (e.g., optical resolution charts for horizontal/vertical resolution, rulers for working distance). For the non-clinical tests like sterilization, the ground truth is established by validated laboratory methods (e.g., biological indicators for sterility assurance).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. (See #8)

Summary of Device and Study Focus:

The VS3-ETV is an endoscope system. The 510(k) submission focuses on demonstrating that the modified device (VS3-ETV, with added working channels) is substantially equivalent to a previously cleared predicate device (VS3, K141002). This means the primary "study" involved comparing the technical specifications and conducting non-clinical performance tests (reuse, cleaning, disinfection, sterilization) to show that the addition of working channels does not introduce new safety or effectiveness concerns compared to the predicate. The reference device K983365 (Aesculap Minop System) was used to establish precedence for the irrigation and working channels concept itself. There is no mention of clinical trials or studies involving patient data to establish new clinical performance criteria for this modification.

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The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

• Endoscope
• Light source
• Camera Control Unit (CCU)
• Camera
• Display monitors
• 2D Endoscope coupler

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way a typical performance study for AI/ML devices might. Instead, it focuses on general performance standards, substantial equivalence to predicate devices, and regulatory compliance.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of comparison to predicate devices, particularly regarding technical specifications. The study described is a comparison of the subject device (VS3-OT) with legally marketed predicate devices, focusing on demonstrating substantial equivalence rather than a standalone performance study with a test set, ground truth, and human readers in the traditional sense.

Here's an attempt to structure the information according to your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for Visionsense Ltd VS3 Stereoscopic High Definition Vision System, Model VS3-OT

The provided document describes the regulatory submission for the VS3 Stereoscopic High Definition Vision System, Model VS3-OT, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone performance study with explicit acceptance criteria and corresponding performance metrics for a novel AI/ML algorithm.

The "acceptance criteria" can be inferred from the technical specifications of the predicate devices which the subject device aims to match or exceed to demonstrate substantial equivalence. The "study" refers to the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the VS3-OT (an endoscope), performance standards often relate to optical and physical characteristics. Since this is a substantial equivalence submission, the "acceptance criteria" are the performance characteristics of the predicate devices. The "reported device performance" is the VS3-OT's specifications.

Note: "Meets" indicates that the subject device's reported performance is comparable to or better than the predicate devices' specifications, supporting the claim of substantial equivalence for these technical characteristics.

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

This document does not describe a "test set" in the context of an AI/ML algorithm evaluation with a specific sample size of cases or images. The "study" relies on a direct technical comparison against the published specifications of predicate devices. There is no information about data provenance (e.g., country of origin, retrospective/prospective) for a test set, as such a test set is not explicitly detailed.

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

Not applicable. The document does not describe a test set that requires expert-established ground truth for an AI/ML algorithm. The comparison is based on objective technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert review process described in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not performed or described in this submission. The device is an imaging system (endoscope), not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a surgical vision system; it is not an AI algorithm performing standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the published technical specifications and performance characteristics of the legally marketed predicate devices, which serve as the benchmark for demonstrating substantial equivalence. There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel AI algorithm's performance.

8. The Sample Size for the Training Set

Not applicable. This submission is for a conventional medical device (endoscope), not an AI/ML system developed with a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set for an AI/ML algorithm, the method of establishing its ground truth is not relevant here.

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Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

This submission describes a Substantial Equivalence (SE) determination for a medical device, meaning the device's acceptable performance is demonstrated by its similarity to already legally marketed predicate devices, rather than through independent studies with specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, ground truth, expert involvement, etc.) is not applicable in the context of this 510(k) summary.

Here's a breakdown of what can be extracted and why other parts are not available:

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

• Not Applicable. In a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the new device's technological characteristics, indications for use, and principles of operation are sufficiently similar to those of a legally marketed predicate device such that no new questions of safety or effectiveness are raised. The performance is "reported" by showing these similarities, not by meeting specific quantifiable performance metrics in independent studies for this particular submission.

Instead, the submission presents a comparison table demonstrating the similarities between the subject device (VS3-NE) and its predicate devices (VSII System K081102 and VS3 K123467).

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

• Not Applicable. This 510(k) submission does not include a clinical or performance test set in the conventional sense (i.e., a set of medical images or patient data used to evaluate algorithm performance). The "test" for substantial equivalence is the comparison of the device's specifications and intended use against predicate devices.

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 Applicable. No ground truth establishment by experts is described in this submission, as it focuses on substantial equivalence to existing devices.

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

• Not Applicable. There is no test set or adjudication process described as this is a substantial equivalence submission.

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 a stereoscopic high definition vision system (an endoscopic camera system), not an AI algorithm designed to assist human readers or perform diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

• Not Applicable. This is a hardware vision system, not an algorithm, so standalone algorithm performance is not relevant.

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

• Not Applicable. There is no ground truth, in the sense of medical diagnostic accuracy, required for this substantial equivalence submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no AI component or training set described in this submission.

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

• Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary of the K131434 Submission:

The K131434 submission is for the VS3 Stereoscopic High Definition Vision System, Model VS3-NE, an endoscope. The device's approval is based on its Substantial Equivalence to two predicate devices:

• Visionsense Ltd VS (K081102)
• Visionsense Ltd VS3 (K123467)

The submission argues for substantial equivalence based on the following:

• Same Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and for visualization of ventricles and structures within the brain during neurological surgical procedures.
• Similar Principles of Operation: Proximal HD camera concept with a stereoscopic camera block, capturing right and left images for a 3D video stream.
• Similar Technological Characteristics: The device shares core components and specifications (e.g., rigid stainless steel endoscope, similar diameter, length, field of view, and direction of view) with the predicate devices.

The submission also notes compliance with several recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, ISO 14971, ISO 8600 series). These standards are device-specific performance criteria for safety and manufacturing, not diagnostic acceptance criteria.

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