(42 days)
The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.
The provided text is a 510(k) summary for the Remington Medical Inc. Model 6149 Pacing Vector Selector Patient Adapter Cable. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, as these are typically part of a detailed study report or testing documentation, not a 510(k) summary.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.
I can only extract the following relevant information from the provided text:
- Device Name: Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable
- Device Description: A manually operated 3-channel Patient Adapter Cable designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It has no active circuits or power sources. It features a 2-pole, 5-position switch to select between five pacing vector options.
- Intended Use: Used during chronic implantation of a pacing or defibrillation lead system for PSA measurements, providing the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
- Technological Characteristics Summary: The Model 6149 is an accessory to the ERA 300, and its addition is considered minor, raising no safety or effectiveness concerns.
To answer your specific questions, information not present in the provided text includes:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. The device is a passive adapter cable, not an AI or imaging device that would typically undergo such a study.
- If a standalone study (algorithm only without human-in-the-loop performance) was done: Not present. The device is an adapter, not an algorithm.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed performance study report. It indicates the device is a simple, manually operated adapter cable with no active components, making many of your questions about AI study methodologies (like training sets, ground truth establishment, and expert adjudication) not applicable to this particular device.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).