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The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing.

The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.

This document is a 510(k) summary for a medical device lead, which assesses its substantial equivalence to a predicate device. It doesn't contain information about machine learning algorithms, AI performance, or studies with acceptance criteria comparing device performance against specific metrics using expert-derived ground truth.

Therefore, most of the requested information cannot be extracted from the provided text. The document focuses on regulatory approval based on similarity to an existing device, rather than a performance study involving AI or complex statistical analysis against defined acceptance criteria.

Here's a breakdown of what can be inferred or stated as unavailable based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing the modified device's characteristics are substantially equivalent to a previously cleared predicate device, rather than setting and meeting specific performance criteria.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no described test set of data (in the context of AI/ML) is mentioned. The "Summary of Studies" refers to bench tests and material characterization, not performance on a data set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set requiring expert-established ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no mention of a test set.
• 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 applicable. This document pertains to a physical medical device (a lead), not an AI-assisted diagnostic or interpretative system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The document describes bench testing and material characterization for a physical device, not an AI/ML algorithm requiring ground truth annotation.
• 8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for a training set is mentioned.

What the document does describe in terms of "studies" and "equivalence":

• Summary of Studies: "Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M."
  • This indicates that bench testing and material characterization were performed. However, specific acceptance criteria or performance numbers from these tests are not provided in this summary. The "qualification by similarity" implies that the new material performed equivalently to a previously validated material, but the details of that equivalence are not here.
• Predicate Device: The predicate device is "the currently market released Model 4951M Lead." This means the current submission is for a modified version of an already approved device.
• Technological Characteristics: "The technology used with the Model 4951M Lead has is the same technological characteristics as the predicate device."
• Conclusion: "Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device."

In essence, this is a regulatory document focused on demonstrating that minor modifications to an existing device do not change its fundamental nature or intended use, thereby justifying approval via the Special 510(k) pathway. It does not provide the kind of performance data with acceptance criteria that would be found in a study for an AI/ML device.

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