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The Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.

Harmac Temporary Pacing Catheter with Stylet

This document is a 510(k) clearance letter from the FDA for a medical device, the Harmac Temporary Pacing Catheter with Stylet. It is not a study report or a technical performance document for an AI/ML powered device. As such, it does not contain the requested information regarding acceptance criteria or a study proving device performance against such criteria.

The letter primarily states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and outlines the regulatory framework for its marketing.

Specifically, the requested information cannot be found in this document:

1. A table of acceptance criteria and the reported device performance: Not present. This document only includes the Indications for Use.
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 is a traditional medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a traditional medical device, not an AI/ML device.
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.

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