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The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments.

The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with:

• Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long.
• Medtronic cardiovascular stimulating instruments.

The 5492 A-V Patient Cables are reusable patient cables that are designed to connect a temporary pacemaker to atrial and ventricular pacing lead systems.

The provided text describes a 510(k) premarket notification for Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables. These are reusable patient cables intended to connect atrial and ventricular pacing lead systems to a temporary external pacemaker. The submission asserts substantial equivalence to a predicate device, the Medtronic Model 5487/5487L Disposable Patient Cables (K960446).

However, the document does not contain specific acceptance criteria values or detailed performance data from a study that proves the device meets those criteria. It lists the types of tests performed (Sterilization, Biocompatibility, Electrical Safety, and Performance Testing - Bench) and concludes that the device is substantially equivalent, but it does not provide the results of these tests in a way that allows for a table of acceptance criteria vs. reported performance.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

The document does not provide a table of acceptance criteria with specific numerical targets or the reported performance data against those targets. It only states that the following tests were completed:

• Sterilization
• Biocompatibility
• Electrical Safety
• Performance Testing (Bench)

The "Conclusion" section broadly states that "Medtronic has demonstrated that the 5492 A-V Patient Cables described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent from the predicate device." This implies the device met the criteria outlined in these tests, but the specific criteria and results are not detailed.

2. Sample size 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 in the document. The text only mentions "bench tests" were performed.

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 applicable as the document describes a medical device (patient cables) and its physical/electrical performance, not an AI or diagnostic imaging device that requires expert ground truth for interpretation.

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

This information is not applicable for the same reason as point 3.

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 applicable as the document is about patient cables, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a patient cable, not an algorithm.

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

This information is not applicable as the device is a patient cable, not a diagnostic tool requiring ground truth for clinical interpretation. The "ground truth" for performance would be established by engineering and safety standards, but the specifics are not detailed.

8. The sample size for the training set

This information is not applicable as the device is a patient cable, not a machine learning model.

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

This information is not applicable as the device is a patient cable, not a machine learning model.

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