(35 days)
The Bard CruraSoft Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of chest wall defects and hernias, including diaphragmatic/hiatal hernias.
The proposed device is heart shaped and has a porous polytetrafluoroethylene (PTFE) side and an expanded polytetrafluoroethylene (ePTFE) side that are connected to each other on the edge with an interlocking monofilament PTFE stitch. There is also a row of stitching that is in a "V" shape which allows the device to be tailored. The prosthesis may be trimmed to the outside of the "V" stitching. The "V" stitching will continue to keep the two layers of the device together if it is tailored. An ePTFE flap is sewn to the superior edge of the patch to minimize the possibility of the device adhering to undesired structures, such as the esophagus. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.
The provided text describes the Bard CruraSoft Patch, a surgical mesh, and its 510(k) summary for regulatory clearance. It focuses on device description, intended use, and similarities/differences with predicate devices. The "Performance Data" section briefly mentions bench testing but does not provide detailed acceptance criteria or a study proving that the device meets those criteria.
Therefore, many of the requested details cannot be extracted from this document, as they are not present. This document is a regulatory submission summary, not a detailed scientific study report.
Here is what can be inferred or stated based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Bard CruraSoft Patch will meet the established specifications necessary for consistent performance during their intended use..." |
Missing Information: The document states that performance data from bench testing "supports the safety and effectiveness" and that the device "will meet the established specifications." However, it does not list what those established specifications (acceptance criteria) are, nor does it provide specific quantitative results of the bench testing.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (presumably internal laboratory testing, but no country of origin or retrospective/prospective nature is mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study or human reader assessment is described.
4. Adjudication method for the test set:
- Not applicable as no clinical study or human reader assessment 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:
- No MRMC study was done. This device is a surgical patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm/AI.
7. The type of ground truth used:
- For the bench testing mentioned, the "ground truth" would be established engineering specifications and material science standards for the physical properties and performance of the patch (e.g., tensile strength, biocompatibility, porosity, attachment integrity). The document confirms that "laboratory test results demonstrate that the materials chosen and the design utilized... will meet the established specifications."
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.