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Mono-Dox, Monofilament Synthetic Absorbable Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

Mono-Dox suture is not indicated for use in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

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The provided document is a 510(k) summary for a medical device (Mono-Dox™ Suture). It focuses on establishing substantial equivalence to a predicate device based on material, performance, and intended use, rather than presenting a study with acceptance criteria for device performance as would typically be seen for a new diagnostic or AI-powered device. Therefore, a direct answer to the request about acceptance criteria and a study to prove it, in the context of an AI/diagnostic device, cannot be fully provided from this document.

However, I can extract the relevant information regarding the basis of acceptance for this specific medical device, which is substantial equivalence to an existing predicate device.

Here's how to interpret the document in the context of your request:

Acceptance Criteria and Reported Device Performance (as defined by this document)

The "acceptance criteria" for the Mono-Dox™ suture are implicitly defined by its ability to meet or exceed the performance requirements of the predicate device (Ethicon PDS II) and the United States Pharmacopeia (USP) 24 standards for absorbable sutures.

Note: The document explicitly states that Mono-Dox and PDS II sutures "both meet or exceed the performance requirements (except for diameter) set forth by USP 24." This indicates that the USP 24 standards are the primary objective criteria for performance acceptance, and the predicate device serves as a benchmark for equivalence in other characteristics.

Study Information (as requested, but not fully applicable to this document's context)

Since this document is a 510(k) summary demonstrating substantial equivalence for a suture (a traditional medical device, not an AI/diagnostic tool), many of the specific questions about studies in your prompt are not directly addressed or are not relevant to this type of submission. I will answer them based on what can be inferred or stated as not applicable from the given text.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" study. The comparison is made against the properties of the predicate device and USP 24 standards. The data provenance would be laboratory testing to confirm material properties and mechanical strength.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture properties (tensile strength, absorption rate) is established through standardized laboratory tests and USP monographs, not expert consensus.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and submission.
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 not an AI/diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for performance characteristics (strength, absorption, material composition) is based on standardized laboratory testing methods against established specifications (USP 24) and comparison to a legally marketed predicate device (Ethicon PDS II).
7. The sample size for the training set: Not applicable. This is not an AI/diagnostic device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/diagnostic device.

In summary: The acceptance criteria for the Mono-Dox™ suture are primarily defined by its ability to meet or exceed USP 24 standards and demonstrate substantial equivalence in materials, performance, and intended use to the predicate device, Ethicon PDS II. The "study" proving this is implicitly a series of laboratory tests demonstrating compliance with these standards and characteristics. The specific AI/diagnostic device-related questions are not addressed by this document.

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