(56 days)
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 Confirm RxTM ICM 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.
- Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool are used to implant the device subcutaneously.
- Magnet: The 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™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The mobile application 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 system allows physicians to remotely monitor and diagnose patients' cardiac events.
This document is a 510(k) summary for the Abbott Confirm Rx Insertable Cardiac Monitor (ICM) with updated MR Conditional labeling. It focuses on demonstrating substantial equivalence to a previously cleared version of the device, specifically for MR Conditional labeling for 3T MRI environments. The acceptance criteria and study described primarily relate to this MR Conditional aspect, not the core cardiac monitoring functionality.
Here's the information extracted from the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the testing performed supports additional 3T MR Conditional labeling. It explicitly mentions that the "3T testing meets the same clinical acceptance criteria that was previously evaluated for predicate 1.5T MR Conditional labeling demonstration of safety."
While the specific clinical acceptance criteria for MR Conditional labeling (e.g., maximum temperature rise, induced voltage, artifact size, device malfunction rates) are not detailed within this summary, the outcome is reported as:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| MR Conditional for 3T MRI environments | The device demonstrates safety for MRI scans in a 3T scanning environment. |
| Functional Integrity Post-MRI | The device functions in accordance with product specifications after 3T MRI exposure. |
| Safety for Intended Use Post-MRI | The device is safe for its intended use after 3T MRI exposure. |
The document concludes that: "The results of the MRI verification testing have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated MR Conditional labeling functions in accordance with product specifications." and "The results of the testing show that the candidate Confirm Rx™ ICM performs as intended and is safe for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used for the MR Conditional testing. It generically refers to "all necessary device and system verification testing."
The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned. Given the nature of MR Conditional testing, it would typically be conducted in a controlled lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For MR Conditional testing, ground truth typically relates to engineering measurements against pre-defined safety limits (e.g., temperature probes, E-field/H-field sensors, functional checks), rather than expert medical interpretation of diagnostic outputs.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. For MR Conditional testing, results are typically objective measurements against engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done as this submission focuses on updated MR Conditional labeling for a device, not the interpretation of its diagnostic output by human readers. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study
The document implies a standalone (algorithm only) performance study related to MR Conditional labeling, as it focuses on the device itself and its interaction with MRI fields. The "results of the MRI verification testing" demonstrate the device's functional integrity and safety. This testing is conducted on the device without human interpretation of its outputs during the test itself, only checking if the device continues to function correctly after the MRI exposure.
7. Type of Ground Truth Used
The ground truth used for the MR Conditional testing is based on engineering standards and design specifications for safe performance in an MRI environment. This includes, but is not limited to, parameters like temperature rise, induced voltage, and device functionality post-exposure, which are objectively measurable and compared against established safety thresholds.
8. Sample Size for the Training Set
The document describes pre-market notification for an updated label for an existing device. It does not mention any "training set" in the context of an AI/ML algorithm. This device is an implantable cardiac monitor, and the current submission is for an updated MR Conditional label, not for a new or updated AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set related to an AI/ML algorithm in this document, this information is not applicable.
§ 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).