(16 days)
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.