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Permanent pacing lead, Model Petite™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

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This document is a 510(k) premarket notification for a medical device submitted to the FDA and primarily assesses substantial equivalence to a predicate device, rather than providing a detailed study on specific acceptance criteria and performance metrics of the new device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC study effect sizes is not explicitly present within the provided text.

The document focuses on:

• Safety and effectiveness problems associated with permanent pacing leads in general (not specific to the Model Petite™ lead). This section defines potential complications and issues that could lead to device malfunction or patient harm.
• FDA's determination of substantial equivalence of the Model Petite™ lead to a legally marketed predicate device.
• Indications for Use for the Model Petite™ lead.

Without a detailed performance study report, which is typically a much more extensive document than what is provided here, it's impossible to fill in the requested table and answer the study-specific questions.

However, based on the provided text, we can infer the general categories of concerns that would likely be addressed in such a study, even if the specific metrics are absent.

Here's a breakdown of why this information is missing and what would typically be expected:

1. A table of acceptance criteria and the reported device performance: This would be found in a performance study report, which is not included here. The Summary and Certification section only lists general problems associated with pacing leads, not specific acceptance criteria for the Model Petite™.

2. Sample size used for the test set and the data provenance: Not present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.

4. Adjudication method for the test set: Not present.

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: Not present. This device is a pacing lead, not an AI-assisted diagnostic tool, so an MRMC study related to human readers and AI would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Again, this is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.

8. The sample size for the training set: Not present.

9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory approval letter for a medical device (a pacing lead) based on substantial equivalence. It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical for diagnostic devices or AI-driven systems.

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