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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.

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.

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The Model 4160 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4161 PSA disposable threshold cable is intended to connect IS-1 or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.

The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 4051A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.

PSA Cable Model Numbers 4160 and 4161 PSA Cable Adapter Model Number 4053A

The provided text is a 510(k) Summary for St. Jude Medical PSA Cables and Adapters. It primarily focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a study related to acceptance criteria and device performance in the context of an AI/ML medical device.

Therefore, the requested information elements related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document.

The document does not detail specific acceptance criteria for performance metrics that would be relevant to an AI/ML system, nor does it describe a study to prove such criteria were met. Instead, it attests to the substantial equivalence of the new devices (PSA cables and adapter) to previously approved devices based on their intended use and design, as per the 510(k) premarket notification process for conventional medical devices.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance: This information is not provided in the context of performance metrics that would typically apply to an AI/ML device (e.g., sensitivity, specificity, AUC). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no such performance study for an AI/ML model is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) 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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of cardiac pacing system cables and adapters through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to predicate devices, not on the performance evaluation of an AI/ML algorithm against specific acceptance criteria.

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