Search Results

The Proposed Device is indicated for the repair of inguinal hernia defects.

The Proposed Device, the Bard Sperma-Tex Preshaped Mesh, is manufactured from knitted polypropylene monofilament. The mesh is cut in a thumbnail design. A patch of e-PTFE is stitched onto one side of the mesh, at the rounded corner, with polypropylene monofilament.

The provided text is a 510(k) summary for a medical device (Bard® Sperma-Tex Preshaped Mesh), which focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a full-fledged clinical study. Therefore, much of the requested information (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, training set details, and how ground truth was established in a clinical sense) is not present.

However, I can extract the explicit acceptance criteria for the technological characteristics and the laboratory tests conducted to demonstrate similarity to the predicate devices.

Here's the information derived from the provided document:

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

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

• Sample Size: Not specified for any of the laboratory tests. The document broadly refers to "laboratory testing" and "material evaluations."
• Data Provenance: Not explicitly stated, but the tests appear to be conducted by the manufacturer ("Testing was performed to assess the effects of the new characteristics of the Proposed Device" and "laboratory testing"). It is retrospective in the sense that existing biocompatibility data from the Predicate Composix was leveraged. No indication of country of origin for new testing, but the submitting company is in the USA.

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

• Not applicable/Not specified. The "ground truth" here is based on established scientific methods and material property specifications, not expert consensus on diagnostic images or clinical outcomes.

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

• Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation tasks, not material property testing.

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. This device is a surgical mesh, not an AI-powered diagnostic device.

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

• Not applicable. This is not an algorithm, but a physical medical device.

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

• For biocompatibility: Ground truth was established by prior biocompatibility testing of the predicate device materials (polypropylene and e-PTFE) according to FDA General Memorandum #G95-1, indicating acceptability for tissue contact.
• For material properties (pore size, surface roughness, mesh integrity): Ground truth was based on established scientific benchmarks and references (e.g., "References indicate that a surface pore size of less than 1 micron on average minimized cellular penetration and tissue attachment." and "average roughness of less than 10 microns would minimize cellular and tissue attachment."). These benchmarks were used to compare the measured properties of the new device's components.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Ask a specific question about this device