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The provided text is a 510(k) Summary for a medical device (Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit) claiming equivalence to a predicate device (Bard Davol Repair Kit). This summary focuses on establishing substantial equivalence based on existing clinical history of similar materials and predicate devices, rather than presenting a performance study with detailed acceptance criteria and results for the new device itself.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and reader studies is not available in this type of document because the regulatory pathway chosen (510(k) for substantial equivalence) doesn't typically require a de novo performance study. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is absent:

Acceptance Criteria and Study for Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit

Given the nature of the provided 510(k) Summary, the "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance targets for the new device in a dedicated de novo study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A) for a de novo test set. This 510(k) relies on the existing "years of clinical history" of similar products and the established safety and effectiveness of the predicate device (Bard Davol Repair Kit). No specific "test set" or its provenance is mentioned for the Rivas™ Kit itself.

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

• N/A. No de novo test set requiring expert ground truth establishment for the Rivas™ Kit is described. The basis is clinical history and predicate device performance.

4. Adjudication method for the test set

• N/A. No de novo test set requiring adjudication for the Rivas™ Kit 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

• N/A. This device is a physical vascular catheter repair kit, not an AI/software device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• N/A. This is a physical medical device, not an algorithm, so standalone performance in that context is not applicable.

7. The type of ground truth used

• Clinical History and Predicate Device Performance: The "ground truth" for the substantial equivalence claim is the established safety and efficacy of:
  • Vascular access products fabricated from silicone elastomer (general category).
  • The predicate Bard Davol Repair Kit.
  • The materials utilized in the Medtronic PS Medical Rivas™ Kit based on their own "clinical in-vivo safety and efficacy."

8. The sample size for the training set

• N/A. This is not an AI/machine learning device, so the concept of a "training set" is not applicable. The basis for safety and efficacy comes from existing clinical history and the predicate device, not from training a model.

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

• N/A. As above, the concept of a "training set" is not applicable here.

Summary of What the Document Provides:

Instead of a detailed performance study for the new device, the 510(k) Summary asserts that the Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit is substantially equivalent to the Bard Davol Repair Kit based on:

• Established clinical history of silicone elastomer vascular access products.
• Proven safety and effectiveness of the predicate Bard Davol Repair Kit.
• Demonstrated in-vivo safety and efficacy of the materials used in the Rivas™ Kit.
• The expectation that complications will be similar to those of existing, similar procedures and devices.

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