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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

The provided document for K130782, the AccuMesh Positioning System, does not contain information related to acceptance criteria or a study proving device performance. This 510(k) submission is solely for adding an orange ink component to an already cleared device.

Therefore, I cannot extract the requested information using the provided text.

Here's why:

• Nature of the Submission: This is a 510(k) summary for a minor change (component color addition) to an existing, cleared device. Such submissions typically focus on demonstrating that the change does not alter the fundamental safety or effectiveness of the device, rather than presenting new performance studies or acceptance criteria.
• Missing Sections: The document lacks sections typically found in an initial 510(k) submission that would detail performance data, clinical studies, or engineering tests against specific acceptance criteria.
• Focus on Equivalence: The primary goal of this particular 510(k) is to establish substantial equivalence to previously cleared AccuMesh devices, emphasizing that "There are no changes to the technological characteristics as a result of the proposed colorant addition."

If you have a document for an initial clearance of the AccuMesh Positioning System (e.g., K101218, K103269, or K123066), that document might contain the information you're looking for.

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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh Positioning System is laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

The provided text describes a 510(k) submission for the AccuMesh Positioning System. The submission is for a component color change and asserts substantial equivalence to previously cleared devices. Therefore, the study details are minimal and do not contain information typically found in a comparative effectiveness study for a new AI/medical device.

Here's the breakdown of the information requested based only on the provided text:

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. The document states "Performance testing was performed on the colorant and consisted of opening, closing and articulating with visual inspection following aging at all hinge joints". It does not detail how many units were tested.
• Data Provenance: Not specified. The testing was performed on 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. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring expert assessment.

4. Adjudication method for the test set

Not applicable. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring adjudication.

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. This document does notdescribe an MRMC study or any study involving human readers or AI assistance. The submission is for a minor change (component color) to an existing device.

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

No. This document does not describe an algorithm or AI.

7. The type of ground truth used

"Ground truth" in the typical sense of clinical validation is not applicable here. The "ground truth" for this submission's performance testing was the ability of the device components (after a color change) to perform their intended mechanical functions (opening, closing, articulating) without issues, verified by visual inspection after aging.

8. The sample size for the training set

Not applicable. This document does not describe an AI or an algorithm that requires a training set.

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

Not applicable. This document does not describe an AI or an algorithm that requires a training set.

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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh Positioning System is a manual laparoscopic device intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. The AccuMesh Positioning System comprises two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to fur! the mesh tightly and rapidly over the AccuMesh positioning system.

The provided text describes a 510(k) submission for the Covidien AccuMesh Positioning System, specifically regarding the addition of a furling sleeve. It claims substantial equivalence to previously cleared devices (K101218 and K103269). However, the document does not contain the detailed performance data, acceptance criteria, or study specifics required to answer many of your questions.

Here's an analysis of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not detailed in the document. The text only says: "Performance testing was conducted using sterilized samples of the proposed design of the AccuMesh Positioning System with the furling sleeve. The furling sleeve interface and compatibility with laparoscopic ports and components of the AccuMesh Positioning System were evaluated with various commercially available mesh products." This is a high-level statement about the type of testing, not the results or specific metrics.

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

• Sample Size: Not specified. The document only mentions "sterilized samples" without a number.
• Data Provenance: Not specified. It does not mention country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it would typically involve prospective lab/bench testing or potentially animal studies, but the document doesn't specify.

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

• Not Applicable. This device is a manual surgical instrument, not an AI or imaging diagnostic tool that typically relies on expert ground truth for performance evaluation in the way you're asking. Its performance evaluation likely focuses on mechanical and functional aspects, compatibility, and usability by surgeons.

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

• Not Applicable. See point 3.

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 not an AI-assisted diagnostic or imaging device. It's a manual surgical instrument.

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

• Not Applicable. This is a manual surgical instrument, not an algorithm.

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

• Not Applicable/Not Specified. For a manual surgical tool, "ground truth" would relate to its ability to perform its stated function (e.g., correctly deliver and position mesh without failure, demonstrating compatibility). The document does not detail how this "truth" was established beyond the general statement about performance testing.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

Summary of what is missing from the provided text to answer your questions:

The provided text is a 510(k) summary focused on the administrative aspects and the claim of substantial equivalence for a manual surgical instrument. It explicitly states that "Performance testing was conducted using sterilized samples..." but does not provide any specific data, metrics, acceptance criteria, or detailed methodology from those tests. Therefore, most of your questions, which are geared towards performance evaluation of AI/diagnostic tools, cannot be answered from this document.

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