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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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The VS3 is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

The VS3 consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") system 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 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

The provided text describes a 510(k) submission for the Visionsense VS3 Stereoscopic Vision System, a Class II medical device. However, it does not contain the detailed information required to fill out the table regarding acceptance criteria, study details, and performance metrics as it is primarily focused on establishing substantial equivalence to a predicate device.

Specifically, the document states:

• "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes."
• "However, the VS3 system and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. In addition, cleaning validation, sterilization, and software validation were performed for the subject device. The completed testing listed above demonstrates that the subject device is as safe and effective as the predicate device."

This indicates that the "study" proving the device meets acceptance criteria is primarily a series of verification and validation tests against recognized consensus standards and internal quality controls, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or other performance metrics typically associated with AI/software devices. Therefore, many of the requested fields cannot be answered from the provided text.

However, based on the information provided, here's what can be extracted and what cannot be:

1. Table of acceptance criteria and the reported device performance:

Note: The text explicitly states "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes." This implies there are no specific quantitative or clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) provided in this document as would be expected for a diagnostic AI device. The "performance" described focuses on meeting safety, electromagnetic, and material standards, and demonstrating functional equivalence to the predicate device with the added feature of HD.

Additional Information (where available or noted as unavailable):

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

• Not provided. The document describes engineering and quality assurance validation (e.g., electrical safety, sterilization validation) against consensus standards but does not detail sample sizes or data provenance for a "test set" in the context of clinical performance data or AI model evaluation.

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

• Not applicable/Not provided. This information is relevant for studies validating interpretations or diagnostic outputs, typically in AI/software clinical performance studies. The provided text does not describe such a study.

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

• Not applicable/Not provided. As above, this pertains to expert-led ground truth establishment for performance studies.

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, an MRMC comparative effectiveness study was not done (or at least not described in this submission summary). The device is a stereoscopic vision system (hardware-based 3D visualization), not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not provided. The device is an endoscopic system providing visualization, not a standalone algorithm.

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

• Not applicable/Not provided. The device's validation focuses on engineering and safety standards, and functional equivalence to a predicate, rather than validating against a clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device in the context of this submission. "Training set" would not apply in the conventional sense.

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

• Not applicable/Not provided. As above, this is not an AI/machine learning device.

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The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as 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.

Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.

The provided text is a 510(k) summary for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.

The section titled "Performance" states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for arthroscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."

This indicates that the submission primarily relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided document.

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

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

• Acceptance Criteria: Not explicitly stated in the document for product performance. The document mentions compliance with "international standards for electrical safety, electromagnetic compatibility, and biocompatibility," which serve as regulatory acceptance criteria for device components, but not performance criteria related to its imaging capabilities or clinical effectiveness.
• Reported Device Performance: Not detailed in terms of a clinical or technical performance study with specific metrics. The document focuses on the system's ability to provide "stereo vision" by capturing images from slightly different angles and processing them for display.

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/Not provided. The document does not describe a clinical or technical performance study with a test set.

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/Not provided.

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

• Not applicable/Not provided.

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/Not provided. This device is a vision system, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This device is a vision system for human use, not an automated algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. The document does not describe a machine learning model requiring a training set.

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

• Not applicable/Not provided.

Summary of available information related to performance/equivalence:

• Device: Visionsense Stereoscopic Vision System (VSn)
• Intended Use: Viewing internal surgical sites during anterior and posterior spinal procedures (nucleotomy, discectomy, foraminotomy), general surgical procedures, and visualization of ventricles and structures within the brain during neurological surgical procedures.
• Technological Characteristics: Proprietary CCD camera with a Lenticular Array to capture images from slightly different angles, mimicking natural human stereo vision. Images are processed and presented on a stereoscopic display panel.
• Basis for Clearance: Substantial Equivalence to predicate devices (K081102, K073279, K990635, K051827) and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. The current submission expands the indications for use based on similarity to previously cleared versions and other endoscopes.
• Performance Standards: No specific performance standards or special controls under Section 514 for arthroscopes.

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The VSn is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, as well as 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.

Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses --- the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.

The provided text is a 510(k) Summary and FDA clearance letter for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, detailed study designs, or performance metrics to demonstrate that the device meets specific acceptance criteria.

The document states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for nasopharyngoscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility." This indicates that the regulatory pathway for this device at the time did not require specific performance criteria or a study with quantified acceptance criteria in the way described in your request.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not 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 MRMC study is mentioned. The device is a direct visualization system, not an AI-assisted diagnostic tool in the sense of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a visualization system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and expanding an existing indication for use, rather than presenting a performance study with specific acceptance criteria as you've requested.

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The VSn system is 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.

Visionsense Stereoscopic Vision System (VSu) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses - the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human 'Stereo vision' obtained when the cycs simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the VISIONSENSE Stereoscopic Vision System (VSII), primarily focusing on demonstrating substantial equivalence to a predicate device for an expanded indication (neurosurgical procedures).

The key information available covers:

• Device Information: Trade name, common name, classification, review panel, product code, device class.
• Predicate Devices: K073279 (VSII General Surgery) and K964281 (Aesculap Angled Neuroendoscopes).
• Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and visualization of ventricles and structures within the brain during neurological surgical procedures.
• Technological Characteristics/Principles of Operation: Proprietary CCD camera, Lenticular Array for stereoscopic vision, PC workstation processing, stereoscopic display.
• Substantial Equivalence: Claimed based on technological similarity to the previously cleared general surgery VSII and to other neurosurgical endoscopic devices (Aesculap).

The document explicitly states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for endoscopes. However, the VSII system and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."

This indicates that specific performance acceptance criteria for the expanded neurosurgical indication were not established or assessed in the traditional sense of a clinical performance study with predefined metrics. The submission relies on substantial equivalence to existing devices and compliance with general safety and electromagnetic standards rather than a study demonstrating meeting specific clinical performance acceptance criteria.

Therefore, I cannot populate the table or provide information for points 2 through 9 as requested, as these details are not present in the provided text.

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The VSII system is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

Not Found

The provided text is a 510(k) summary for the Visionsense Ltd.'s VSII System, a stereoscopic vision system for general endoscopic and laparoscopic surgical procedures. It primarily focuses on demonstrating substantial equivalence to a predicate device (ELRAN 01 Stereoscopic Laparoscope) rather than detailing performance studies and acceptance criteria for entirely new device claims.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided document. The 510(k) process for substantial equivalence often relies on demonstrating that the new device performs "as safe and effective" as the predicate, rather than establishing entirely new performance benchmarks through extensive studies typically associated with novel or high-risk devices.

Here's what can be extracted and what is missing:

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

Missing: Specific quantitative acceptance criteria (e.g., minimum resolution, field of view, illumination levels, specific accuracy metrics for stereoscopy) and the quantitative results of the VSII System against these criteria. The document states "Performance data demonstrates," but does not provide the specifics of this data or the defined acceptance thresholds.

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

Missing: The document does not mention any specific "test set" in the context of device performance evaluation, nor does it provide details on sample size or data provenance (country of origin, retrospective/prospective). The assessment appears to be based on a comparison to the predicate device's established performance rather than a new standalone clinical study.

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

Missing: This information is not provided because there is no mention of a "test set" and corresponding ground truth establishment by experts for the VSII system in this summary.

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

Missing: Not applicable, as no test set or expert 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

Missing: This is not applicable to the VSII System, which is a stereoscopic vision system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

The document does not describe a "standalone" algorithmic performance study in the context of AI. The VSII system is a viewing system, not an algorithm. The "performance data" mentioned is likely related to engineering tests and optical characteristics to ensure similar performance to the predicate device.

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

Missing: No "ground truth" in the clinical AI sense is mentioned, as there are no diagnostic claims or classifications being made by the device itself that would require clinical ground truth.

8. The sample size for the training set

Missing: Not applicable, as this is a hardware vision system, not an AI model that undergoes "training."

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

Missing: Not applicable for the same reason as above.

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