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The SJM Confirm® Implantable Cardiac Monitor 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 (MR Conditional) 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), an external patient activator (Model DM2100A) and a programmer. The programmer is used by the physician 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).

This document describes the SJM Confirm® Implantable Cardiac Monitor (MR Conditional) (Model DM2100) and its 510(k) submission (K122161). The submission claims substantial equivalence to two predicate devices: the SJM Confirm® ICM Model DM2100 (K081365) and the Medtronic Reveal DX Insertable Cardiac Monitor (K071655).

The submission focuses heavily on the new "MR Conditional" labeling.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct performance table in terms of diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection) for the SJM Confirm® Implantable Cardiac Monitor.

Instead, the "acceptance criteria" for this 510(k) submission appear to be focused on demonstrating:

• Substantial Equivalence: The device is substantially equivalent to the predicate devices in terms of technological characteristics and intended use.
• MRI Compatibility: The device performs safely and effectively in MRI environments.
• Compliance with Predetermined Design and Performance Specifications: As confirmed by verification and validation activities.

Based on the provided text, the "reported device performance" is largely qualitative and focused on meeting these criteria, rather than specific numerical diagnostic performance metrics.

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

The provided text does not describe a clinical test set with human patient data for evaluating arrhythmia detection or diagnostic performance. All listed tests are "nonclinical tests" (bench tests) related to MRI compatibility and product safety/functionality.

• Test Set (for MRI compatibility, electrical safety, biocompatibility): Not applicable in terms of patient data. The "test set" would consist of the device itself and associated components.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective clinical study, as these were bench tests.

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

Not applicable. No clinical test set requiring ground truth established by experts is described in the provided nonclinical test summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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. The device is an implantable cardiac monitor, not an AI-assisted diagnostic imaging or ECG interpretation system that would involve human readers improving with AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone monitoring system that automatically detects and records ECGs. The document confirms that "verification and validation activities were performed to ensure that the SJM Confirm® ICM devices meet their predetermined design and performance specifications," implying that the device's inherent functional performance (including its algorithms for detection) was tested. However, no specific details about the methodology or results of these "algorithm only" tests are provided beyond the general statement. The focus of this 510(k) is MRI compatibility.

7. The Type of Ground Truth Used

For the nonclinical tests described:

• MRI Compatibility: Ground truth would be defined by the specifications of MRI machines, industry standards (e.g., for heating, force, torque), and post-exposure functional criteria (e.g., does the device still operate to spec?).
• Electrical Safety, Biocompatibility: Ground truth is established by adherence to recognized national and international standards (e.g., ISO-10993-1 for biocompatibility).
• "Predetermined Design and Performance Specifications": The ground truth here is the engineering and functional requirements established during the device's design phase.

8. The Sample Size for the Training Set

Not applicable. The device is not described as an AI/machine learning system requiring a training set in the conventional sense. Its "algorithms" for arrhythmia detection would have been developed through traditional embedded software engineering.

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

Not applicable. As there's no described AI/machine learning training set.

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