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The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Abbott Confirm RxTM (ICM) System consists of the following key features and components:

• Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet: SJM donut magnet, facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Patient App (Model APP1000 (Android) and APP1001 (iOS)): The mobile application provides the means for the patient to activate EGM recording in the Confirm RxTM device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The provided text describes a 510(k) premarket notification for the "myMerlin Mobile Application (Android)" and "myMerlin Mobile Application (iOS)" by Abbott (St. Jude Medical). This application is part of the Confirm Rx™ Insertable Cardiac Monitor System. The submission claims substantial equivalence to a previously cleared predicate device (K192593, Confirm Rx™ Insertable Cardiac Monitor System).

The submission focuses on updates to the myMerlin™ mobile application, primarily related to scheduled background workflows and telemetry connectivity improvements, as well as the ability to transfer a patient's remote monitoring support profile on Merlin.net.

The document states that the fundamental technological characteristics, intended use, indications for use, operating rules, cybersecurity, and usability testing remain the same as the predicate device. Therefore, the testing performed was to demonstrate that the updated mobile application maintains its safety and effectiveness for its intended use, rather than proving performance against new acceptance criteria for a novel functionality.

Given this context, the acceptance criteria and study details are presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size of a "test set" in terms of patient data or scenarios used. The testing described is primarily focused on software verification, system verification, design validation, and Bluetooth Low Energy proxy software verification. This implies testing involved the software application itself and its interaction with the ICM device, rather than a clinical study with a patient cohort.

• Data Provenance: Not applicable in the context of a clinical test set. The provenance of the software updates is from the manufacturer, Abbott. The nature of the changes (software updates) suggests internal testing and technical verification.

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

This information is not provided. Given the nature of the submission (updates to a mobile application interacting with an already cleared device), the "ground truth" would likely be established by engineering and software performance standards, rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

This information is not provided. As noted in point 3, the testing appears to be technical in nature rather than clinical, so a traditional clinical adjudication method would not be expected.

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

No MRMC comparative effectiveness study was mentioned. The myMerlin™ mobile application is primarily a patient interface for activating EGM recording and data pass-through. It is not an AI-assisted diagnostic tool for "human readers," so this type of study would not be relevant.

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

The submission describes the myMerlin™ mobile application (APP1000/APP1001) as a component of the Confirm Rx™ ICM System. The application enables patients to activate EGM recording and facilitates data pass-through to the Merlin.net Patient Care Network for physician review. The focus is on the functional performance of the application and its connectivity, not on a standalone algorithm for diagnosis without human input. Therefore, a standalone algorithm performance study as typically understood for diagnostic AI was not done or described. The "standalone" performance here refers to the application's ability to fulfill its intended technical functions.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the specific updates to the myMerlin™ mobile application, the "ground truth" for verification and validation would be defined by predetermined design and performance specifications or product specifications. This means the software was tested against its expected behavior and technical requirements, rather than against clinical outcomes, pathology, or expert consensus on a clinical dataset. The objective was to confirm that the updated software performed as intended and did not negatively impact the already cleared system's functionality.

8. The Sample Size for the Training Set

This information is not applicable. The myMerlin™ mobile application is not described as involving a machine learning or AI algorithm that would require a "training set" in the conventional sense (i.e., for learning to identify patterns in data). The changes are described as software updates to workflows and connectivity.

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

This information is not applicable, as no training set for a machine learning algorithm is mentioned or implied.

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