(28 days)
The Confirm RxIM 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 atial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm Rx™ ICM Model DM3500 Implantable Device 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 has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include: Patient-initiated triggering of EGM storage using the myMerlin™ Patient App for mobile devices, Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected, Automated triggering of EGM storage when atrial fibrillation (AF) is detected, The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable, Remote care monitoring. The system also includes Implant Tools (incision and insertion tools), a Magnet, a Clinician Programmer (Merlin PCS Programmer Model 3650) with Merlin PCS Model 3330 software, myMerlin™ Patient App (Model APP1000 Android), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator).
This document is a 510(k) premarket notification for a minor design change to an existing device, the Confirm Rx Insertable Cardiac Monitor (ICM) Model DM3500. Therefore, the "study" referred to is primarily verification and validation testing to ensure the modified device still meets its specifications and is substantially equivalent to the predicate device, rather than a clinical effectiveness study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct table of specific acceptance criteria or quantitative performance metrics in the format requested, as it's a submission for a minor design change (adding a "peel and stick moisture getter"). Instead, it focuses on demonstrating that the modified device continues to meet the established design and performance specifications of the predicate device.
The study referenced is the Non-Clinical Test Summary, which involved:
- Risk Analysis (FMEA/FMECA): To assess the impact of the minor design change on hazards and associated risks.
- Verification and Validation Activities: To demonstrate that the device with the new moisture getter material meets its predetermined design and performance specifications.
The reported performance is that the device (with the modification) "functions in accordance with product specifications" and "is as safe and as effective and performs as well as the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size for evaluating the algorithm's performance or device efficacy in a clinical sense. Given this is a 510(k) for a minor design change, the "test set" likely refers to engineering units used for verification and validation tests. The text indicates that these were non-clinical tests.
- Sample Size: Not specified quantitatively for testing the "peel and stick moisture getter." This would typically involve a specific number of devices or components undergoing various environmental, mechanical, and functional tests.
- Data Provenance: Non-clinical (laboratory/engineering tests). No country of origin is explicitly stated for these specific tests, but the company is based in the USA (Sylmar, CA). The tests are described as part of the "verification and validation activities" for the design change.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this submission. The "ground truth" for non-clinical verification and validation tests is typically established by engineering specifications, regulatory standards, and comparison to the predicate device's performance, not by expert medical review of patient data in this specific context.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical data (like ECGs for arrhythmia detection) where adjudication methods (e.g., 2+1, 3+1) would be relevant. The verification and validation activities are engineering-focused.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a minor design change to an existing device and does not involve assessing the impact of AI on human readers. The clinical effectiveness of the Confirm Rx ICM itself would have been established in previous 510(k) or PMA submissions (e.g., K190295 for the predicate device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document states that the fundamental technological characteristics and operating rules of the Confirm Rx ICM (which includes sensing and detection algorithms for arrhythmias) are not changing. Therefore, standalone performance of the algorithms was established with the predicate device (K190295) and is considered unchanged. This submission does not describe a new standalone performance study for the algorithms.
7. Type of Ground Truth Used
For the specific tests related to the "peel and stick moisture getter" modification:
- Ground Truth: Engineering specifications, performance criteria established for the predicate device, and regulatory standards. The goal was to demonstrate that these were still met after the modification.
For the underlying Confirm Rx™ ICM's arrhythmia detection algorithms, the "ground truth" for previous clearances would have likely involved:
- Expert Consensus: Cardiologists or electrophysiologists manually reviewing ECGs/EGMs to identify and classify arrhythmias.
- Clinical Outcomes: Correlating device detections with actual patient events or diagnoses.
However, these details are not provided in this specific document because the algorithms themselves are not being changed or re-evaluated for efficacy here.
8. Sample Size for the Training Set
Not applicable. The document describes a non-clinical modification to a hardware component (moisture getter) and explicitly states that the device's operating rules and functionality (which would include its algorithms) remain the same. This submission does not involve training new algorithms or a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or new algorithm development/training in this submission.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).