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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 St. Jude Medical Confirm Rx™ system consists of the following key features and components:

• Confirm RxTM 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. It is predicated on SJM Confirm™ DM2102 with a two-year longevity, MR conditional labeling, and identical sensing and detection algorithms as SJM Confirm™ DM2102, but with downsized hardware and Bluetooth communication.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet (existing 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): The Patient App provides the means for the patient to activate EGM recording in the Confirm Rx™ 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 the Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the Confirm Rx™ ICM leverages the existing market-cleared SJM Confirm™ (DM2102) algorithms and functionality. Therefore, the "acceptance criteria" for the detection algorithms are implicitly inherited from the predicate device. While specific numerical targets for metrics like sensitivity or specificity are not explicitly stated as acceptance criteria for the Confirm Rx™ ICM in this summary, the key performance aspects verified through testing are:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It typically does not contain the detailed clinical study reports or comprehensive performance metrics that would be found in a full PMA application or a detailed peer-reviewed publication. The "acceptance criteria" here are therefore inferred from the context of substantial equivalence to a previously cleared device.

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

• Test Set Sample Size: The document does not explicitly state a specific sample size for a clinical test set used to evaluate the Confirm Rx™ ICM's diagnostic performance for arrhythmia detection. It states: "R-wave detection and device migration were verified via bench and animal testing for the Confirm Rx™ ICM DM3500." and "The Confirm Rx™ ICM leverages the existing market cleared SJM Confirm™ (DM2102) algorithms and functionality for which the clinical testing, performed on the SJM Confirm™ (DM2102) device per St. Jude Medical IDE G080090, is applicable and was not repeated."
• Data Provenance: The document does not specify the country of origin for the data, but it refers to an IDE (Investigational Device Exemption) study (G080090) conducted for the predicate device, SJM Confirm™ (DM2102). IDE studies are typically prospective clinical trials.

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

• This information is not provided in the 510(k) summary for the Confirm Rx™ ICM. Since the clinical performance data is leveraged from the predicate device, the details about ground truth establishment would reside in the original IDE G080090 submission for the SJM Confirm™ (DM2102).

4. Adjudication Method for the Test Set:

• This information is not provided in the 510(k) summary. Details on adjudication methods would typically be found in the full clinical study report for the predicate device (IDE G080090).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• No MRMC comparative effectiveness study is mentioned. The Confirm Rx™ ICM is an insertable cardiac monitor that automatically detects and records cardiac events. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting medical images or complex waveforms. Its primary function is automated detection and recording, with physician review of the recorded electrograms (EGMs).

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

• Yes, the document implies standalone performance evaluation of the detection algorithms. It states that the Confirm Rx™ ICM utilizes "identical sensing and detection algorithms as SJM Confirm™ DM2102." These algorithms are designed for automated triggering of EGM storage based on detected events like tachycardia, pauses, and atrial fibrillation. The verification of R-wave detection (a fundamental aspect of these algorithms) was performed via bench and animal testing, suggesting an evaluation of the algorithm's performance independent of a human in the loop for the core detection task. Physicians later review the automatically captured EGMs.

7. The Type of Ground Truth Used:

• For the R-wave detection and device migration verification in the Confirm Rx™ ICM, the ground truth would likely be based on direct physiological measurements from bench testing and animal studies (e.g., direct electrical signals or physical tracking of device position).
• For the leveraged clinical performance of the detection algorithms (from SJM Confirm™ DM2102 IDE G080090), the ground truth for arrhythmia detection would typically involve expert consensus of ECG/EGM interpretation by cardiologists or electrophysiologists, potentially corroborated with other clinical data or findings.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. Given that the device leverages "identical sensing and detection algorithms" from a predicate device, the algorithms were likely developed and "trained" (or more accurately, designed and optimized) at an earlier stage with data that is not detailed in this 510(k) summary. This summary focuses on verifying the new device's implementation of those existing algorithms, not on new algorithm development.

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

• This information is not provided in the 510(k) summary. As mentioned, the algorithms are inherited from a predicate. Details on their initial development and the establishment of ground truth for any underlying "training" or optimization data would be found in the documentation for the predicate device (SJM Confirm™ DM2102).

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