(111 days)
The PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality.
The Pacing System Analyzer (PSA) cable, Model 6763, is an external cable used to transmit signals to and from a connected PSA device. The connected PSA equipment is used during the implantation of pacemakers and defibrillators to evaluate the placement and integrity of leads and to determine the appropriate pacing parameters for the implanted device. The PSA cable leadwires are affixed to the implanted lead while the other end of the cable, the trunk cable, is plugged into the external PSA device. The PSA cable is used with the BSC distributed PSA devices.
This document is a 510(k) summary for the Boston Scientific PSA Cable, Model 6763. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria with numerical performance targets for an AI device.
Therefore, many of the requested sections about acceptance criteria, performance metrics, sample sizes, and expert adjudication are not applicable or cannot be extracted from this document, as it pertains to a physical cable intended for signal transmission, not an AI-powered diagnostic device.
Here's a breakdown based on the provided text, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an AI device's performance metrics (e.g., sensitivity, specificity). The "Performance Data" section describes categories of testing for a physical cable.
| Acceptance Criteria Category | Reported Device Performance (as far as applicable for a cable) |
|---|---|
| Sterilization | Verification and Validation (V&V) testing performed. Implied successful. |
| Biocompatibility | V&V testing performed. Implied successful. |
| Electromagnetic Compatibility | V&V testing performed. Implied successful. |
| Electrical Safety | V&V testing performed. Implied successful. |
| Performance/Bench testing | V&V testing performed. Implied successful. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes testing for a physical cable, not a software device that uses a test set of data. The performance section mentions "Design verification and validation (V&V) testing" which refers to laboratory and bench tests for electrical, mechanical, and safety aspects, not a dataset from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert readers to establish ground truth for a diagnostic AI.
4. Adjudication method for the test set
Not applicable.
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 applicable. This is not an AI device for diagnostic assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for a cable's performance would be engineering specifications and standards, verified through bench testing, not clinical outcomes or expert consensus on medical images/data.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.3630 Pacemaker generator function analyzer.
(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).