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The indications for use of 3D Anatomical™ Mesh are:

• l) inguinal hernia repair
• 2. ventral abdominal wall hernia repair

3D Anatomical™ Mesh is manufactured in a class 10,000 clean room environment in accordance with ISO 9001 and EN 46001 regulations. Full traceability will be maintained on all production lots.

The provided document, K990730: 3D Anatomical™ Mesh, describes in-vitro testing and clinical experience for a surgical mesh, but it does not contain information about acceptance criteria related to device performance in a study setting, nor does it detail a study proving the device meets such criteria.

The document does list some in-vitro test results that can be interpreted as de-facto acceptance criteria for manufacturing and material properties, but these are not presented as "acceptance criteria" for a clinical or performance study proving efficacy or safety in a patient population.

Here's an analysis based on the information available in the provided text, while highlighting the absence of information for most of your requested points:

Acceptance Criteria and Device Performance

The document presents in-vitro test results for the 3D Anatomical™ Mesh. These can be considered the required performance specifications that the manufactured mesh must meet.

Missing Information for Device Acceptance Criteria and Performance Studies:

The following points cannot be addressed from the provided text as the document focuses on pre-market notification for a 510(k) submission, which typically relies on substantial equivalence and in-vitro data rather than extensive clinical efficacy studies with predefined acceptance criteria.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   • No information about a "test set" for performance evaluation in humans. The in-vitro tests were conducted by Institut Textile de France and Laboratoire de Rheologie des Matieres Plastiques (both in France).
2. 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 as no clinical performance "test set" with ground truth is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not applicable.
4. 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 a medical device (surgical mesh), not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • Not applicable for a clinical performance study. For the in-vitro tests, the ground truth is established by standardized laboratory testing methods and comparison to reference materials.
7. The sample size for the training set
   • Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set."
8. How the ground truth for the training set was established
   • Not applicable.

Clinical Experience Mentioned:

While not a formal "study" proving acceptance criteria, the document states:

• "Clinical experience of 3D Anatomical™ Mesh began internationally in 1994 and now includes thousands of mesh implants."

This indicates post-market surveillance data or anecdotal reports (prior to the 1999 filing) rather than a controlled study specifically designed to meet pre-defined acceptance criteria for efficacy or safety. The 510(k) approval process often relies on existing clinical use and substantial equivalence to a predicate device rather than new, large-scale clinical trials for every device.

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