Search Results

The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi-filament wire. One end of this wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.

The provided document is a 510(k) summary for a medical device (Model 6494 Unipolar Temporary Myocardial Pacing Wire) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study in the context of AI/machine learning device performance, as implied by the detailed questions.

Instead, the document details physical and functional testing to ensure the modified device meets specified requirements and is equivalent to an existing device.

Here's an analysis based on the provided text, addressing the questions as much as possible, acknowledging where the requested information is not applicable or unavailable:

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

The document states that Medtronic, Inc. performed "system compatibility testing to support that the Model 6494 Unipolar Temporary Myocardial Pacing Wire is equivalent to the predicate device." It then lists the types of tests done and a general conclusion. Specific acceptance criteria and quantitative performance metrics are not provided.

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 document refers to "system compatibility testing" and "device testing" but doesn't specify sample sizes for these tests. There's no mention of a "test set" in the context of data for an AI/ML device.

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 is not applicable to this type of device submission. The device is a physical medical instrument (pacing wire), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from data.

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

This is not applicable to this type of device submission. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations, neither of which is described here.

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 is not applicable. The device is a temporary myocardial pacing wire, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

This is not applicable. The "ground truth" for this device's performance would be against established engineering specifications and international standards for electrical, mechanical, and material properties of such medical devices, rather than clinical outcomes or expert consensus on data interpretation. The document broadly states "meets the specified requirements."

8. The sample size for the training set

This is not applicable. The device is a physical instrument, not an AI/ML model that requires a training set.

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

This is not applicable. As there is no AI/ML training set, there's no ground truth to establish for it in this context.

Ask a specific question about this device