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ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.

The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.

The provided text describes the ULTRAPRO Plug, a surgical mesh device for hernia repair. While it outlines the device's description, intended use, and comparison to predicate devices, it does not contain information related to acceptance criteria, specific performance metrics, or a study design involving a test set, expert adjudication, or AI assistance. The document focuses on establishing substantial equivalence to previously approved devices based on material composition and general performance, rather than providing detailed performance data from a clinical or standalone study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance. The "acceptance criteria" here refer to meeting regulatory requirements for substantial equivalence.
• Reported Device Performance:
  • Biological Reactivity: "acceptable for its intended use."
  • Functional Performance: "meets or exceeds all functional requirements."
  • Basis of Claim: Substantial equivalence to predicate devices (ULTRAPRO Mesh and BARD Mesh PerFix Plug) based on similar technological characteristics and materials.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided. The document refers to "bench and animal testing" but does not specify sample sizes or data provenance for these tests, nor does it detail a "test set" in the context of device performance evaluation against specific criteria.

3. 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)

• This information is not provided. The document relies on existing regulatory approvals of predicate devices and general biocompatibility/functional testing. There is no mention of a "ground truth" derived from expert consensus for a test set.

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

• This information is not provided. No adjudication method is mentioned as there is no described test set requiring one.

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

• This information is not provided. The device is a physical surgical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

• This information is not provided. As mentioned above, this is a physical implant, not an algorithm.

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

• The "ground truth" implicitly used for the device's safety and effectiveness relies on comparison to legally marketed predicate devices and their established safety and efficacy profiles. For the specific performance data mentioned:
  • Biological reactivity: Likely based on standardized in vitro and in vivo toxicology tests (ISO 10993-1).
  • Functional performance: Likely based on bench tests and animal studies designed to assess mechanical properties and tissue integration, with "ground truth" being predefined engineering specifications or biological responses.

8. The sample size for the training set

• This information is not applicable/provided. There is no "training set" in the context of this traditional medical device approval process. This concept is typically relevant for machine learning or AI models.

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

• This information is not applicable/provided.

In summary, the provided document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence, not a performance study report for an AI/ML diagnostic or assistive tool. Thus, many of the requested details regarding acceptance criteria for an algorithm and study design involving a test set, experts, and AI are not present.

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