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510(k) Data Aggregation
(32 days)
The Topera FIRMap™ Mapping Adapter Connector (MAC) is indicated for use with Topera's FIRMap™ Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.
The FIRMapTM MAC is a re-usable, non-sterile, non-patient contact device that is intended to be used in conjunction with the FIRMapTM catheter. The MAC acts as an interface between the catheter and electrophysiology recording system by connecting the extension cable to the EP system fan out cable.
This document describes the regulatory submission for the FIRMap Mapping Adapter Connector (MAC), a reusable, non-sterile device intended to interface Topera's FIRMap™ Catheters with electrophysiology recording systems.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Continuity and High Potential (Hi Pot) | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Mate/Demate Cycle | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
| Mate/Demate Force | Passed (Implicitly, as it's listed as a test undergone and the conclusion states "safe and effective") |
Note: The document states the MAC underwent these tests and, based on the test data, "it has been demonstrated that the MAC is safe and effective for its intended use." This implies that the device met the acceptance criteria for each of these tests, even though specific pass/fail values or detailed results are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the performance tests (Electromagnetic Compatibility, Continuity and Hi Pot, Mate Demate Cycle, Mate Demate Force).
The data provenance is not specified. It is likely internal testing performed by Topera, Inc. as part of their device development and regulatory submission process. There is no indication of country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The FIRMap MAC is a hardware connector, and its performance tests (EMC, continuity, mechanical durability) are typically evaluated against engineering standards and specifications, not against "ground truth" established by clinical experts in the same way a diagnostic algorithm would be.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the type of engineering performance testing conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating results against human interpretations.
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
No, an MRMC comparative effectiveness study was not done. The device is a hardware connector and not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. The device is a passive hardware component, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as expert consensus, pathology, or outcomes data is not directly applicable to the engineering performance tests (EMC, continuity, mechanical) conducted for this device. The "ground truth" for these tests would be the established engineering specifications and regulatory standards that the device must meet to function safely and effectively. For example, for "Continuity and Hi Pot," the ground truth would be a pass/fail according to a predefined electrical resistance or dielectric strength threshold.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The FIRMap MAC is a hardware device developed through engineering design and testing, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, there is no "training set" for this hardware device.
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