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The SJM Confirm™ ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

• . patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• . patients who experience transient symptoms that may suggest a cardiac arrhythmia

The SJM Confirm Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330 Version 6.8.1 (or higher)).

Here's a breakdown of the acceptance criteria and study information for the SJM Confirm Implantable Cardiac Monitor System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative "acceptance criteria" and direct "device performance" metrics in the same way a clinical trial might. However, we can infer the "acceptance criteria" through the comparison to the predicate device and the "reported device performance" through the SJM Confirm's specifications. The core acceptance criterion is that the SJM Confirm ICM is at least as good as, or substantially equivalent to, the predicate device (Medtronic Reveal Plus ILR) in its technological characteristics and intended use.

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

The provided document does not specify a sample size for a "test set" in the context of clinical performance or algorithm evaluation with specific patient data. The studies mentioned are primarily engineering verification and validation (e.g., mechanical, electrical, EMC, firmware, system validation).

The "QRS Detection Accuracy and AF Detection Algorithm Report" (Appendix 7.6) hints at an algorithm evaluation, which would typically involve a test set. However, the details about the size, country of origin, or retrospective/prospective nature of this data are not provided in this summary.

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

Given the lack of detailed information regarding a test set for algorithm performance, the number and qualifications of experts used to establish ground truth are not provided in this document.

4. Adjudication Method for the Test Set

As information about a specific test set for algorithm performance is not provided, the adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is not mentioned in the document. The filing focuses on demonstrating substantial equivalence through technical specifications and engineering testing, not through human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The "QRS Detection Accuracy and AF Detection Algorithm Report" (Appendix 7.6) suggests that some form of standalone algorithm evaluation was performed for QRS detection accuracy and AF detection. However, the document does not provide details about the specific design, results, or full scope of this standalone study.

7. Type of Ground Truth Used

For the engineering tests (e.g., mechanical, electrical), the "ground truth" would be engineering specifications and standards.

For algorithms related to QRS detection and AF detection, the ground truth would typically be established by expert review of ECGs, possibly correlated with other clinical data. However, the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the "QRS Detection Accuracy and AF Detection Algorithm Report" is not explicitly stated in this summary.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This information would typically be provided if there was a detailed description of an algorithm's development and evaluation.

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

Since no training set is explicitly mentioned, the method for establishing its ground truth is also not provided.

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