(13 days)
The Model 6500 Unipolar Temporary Myocardial Pacing Lead 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 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally attached to the conductor wire permits exiting the pacing lead through the chest wall. The electrode terminates distally in an atraumatic myocardial curved needle. The lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. All components of the lead remain in the body, except the silicone rubber disc in case of atrial application.
This Medtronic document (K012452) describes a Special 510(k) Premarket Notification for the Model 6500 Unipolar Temporary Myocardial Pacing Lead. This filing focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against acceptance criteria with a new type of study.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of specific acceptance criteria (e.g., target accuracy, sensitivity, specificity) and corresponding performance metrics for a diagnostic or AI device. Instead, it details various engineering and compatibility tests designed to show the new device performs equivalently to the predicate device.
Here's a summary of the "acceptance criteria" and "reported performance" as inferred from the document:
| Acceptance Criteria Category | Specific Tests Performed by Device | Reported Performance |
|---|---|---|
| System Compatibility | Environmental Conditioning | Meets specified requirements |
| Visual Verification | Meets specified requirements | |
| Dimensional Testing | Meets specified requirements | |
| Electrical Testing | Meets specified requirements | |
| Mechanical Testing | Meets specified requirements | |
| Sterilization | Ethylene Oxide (ETO) Sterilization Process Validation | Processes appropriate for sterilizing the devices were validated. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. The "tests" mentioned are device engineering and compatibility tests.
- Sample Size for Test Set: Not applicable in the context of diagnostic performance on patient data. The sample size for the engineering tests is not explicitly stated (e.g., "how many leads were subjected to dimensional testing?").
- Data Provenance: Not applicable in the context of patient data. The tests were performed internally by Medtronic, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the submission does not involve establishing ground truth for a diagnostic test using expert review of patient data. The "ground truth" for the engineering tests would be the established specifications and expected performance benchmarks for the device components.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human-in-the-loop diagnostic review or ground truth adjudication process described for a test set of patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is typically used to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). The Model 6500 is a physical medical device (a pacing lead), not an AI diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study for an algorithm was not done. The "device" in question is a physical pacing lead, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the studies described relates to engineering specifications and performance standards for a medical device. It's essentially engineering specifications and established performance benchmarks for properties like electrical conductivity, mechanical strength, dimensions, and visual integrity, as well as validated sterilization procedures. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. The Sample Size for the Training Set
This information is not applicable. The Model 6500 is a physical medical device, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
In summary:
This document is a Special 510(k) for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through engineering and compatibility testing, rather than evaluating the clinical performance of a diagnostic algorithm or AI system. Therefore, many of the requested items related to AI/diagnostic study design are not present in this type of regulatory submission.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.