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The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Physio Control, Zoll, and "Anderson" adapted models of monophasic and bi-phasic defibrillators.

These are single use, sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 195.98 Sq.cm. They are radiotransparent. They come in three connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The provided 510(k) summary for K131550 describes Sterile Defibrillator Pads. This submission focuses on demonstrating substantial equivalence to a predicate device (K080421, Heart Sync C-100/T-100) for a sterile version of an already marketed product. Therefore, the "study" described is primarily a non-clinical bench testing and biocompatibility study to confirm that the new sterile version performs equivalently to the non-sterile predicate and meets relevant standards.

Here's an analysis of the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Various different lots containing multiple samples each were subjected to the AAMI tests..." It does not specify an exact numerical sample size for the test set.

• Data Provenance: The testing appears to be prospective bench testing conducted by Heart Sync, Inc. The country of origin for the data is not explicitly stated but can be inferred as the United States, given the company's location and FDA submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable (N/A). This submission pertains to a medical device (defibrillator pads), not an AI or diagnostic imaging device that requires expert ground truth establishment for a test set. The "ground truth" here is defined by objective engineering standards (AAMI, FDA, ISO) and laboratory measurements, not human interpretation.

4. Adjudication Method for the Test Set

Not applicable (N/A). Since the testing involves objective measurements against engineering standards, there is no need for adjudication by multiple human experts. The pass/fail criteria are defined by the standards themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is typically conducted for AI-powered diagnostic tools to assess the impact of AI on human reader performance. Defibrillator pads are a therapeutic device, not a diagnostic one that involves human image or data interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable (N/A). This device does not involve an algorithm. Its performance is assessed through physical and electrical bench testing, and its function is to provide a conductive interface for defibrillation and pacing, not to perform an algorithmic function.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective engineering and biocompatibility standards.

• AAMI Standard ANSI/AAMI DF80:2003: Performance criteria for defibrillator electrodes.
• FDA Performance Standard for Touch-Proof ECG Connectors: Safety and performance criteria for connectors.
• ANSI/AAMI/ISO 11137-2: Sterilization validation standard.
• Biocompatibility testing against established biological safety criteria.
• Direct comparison to the predicate device for attenuator system performance.

8. The Sample Size for the Training Set

Not applicable (N/A). This device is not an AI or machine learning algorithm, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable (N/A). As there is no training set for an algorithm, there is no ground truth to establish for it.

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