(214 days)
The Medtronic Model 9525 Reveal Insertable Loop Recorder is an implantable, patientactivated monitoring system that records subcutaneous ECG and is designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.
The Reveal ILR system is designed to record and store subcutaneous electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9525 implanted recorder and the Model 6190 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9802E software is required for programming and retrieving data from the recorder.
Here's an analysis of the acceptance criteria and study information for the Medtronic Reveal™ Insertable Loop Recorder (K972242), based on the provided text:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a dedicated section with specific numerical targets. Instead, it describes a series of tests performed to ensure the device meets its design and performance requirements, and then concludes with a statement of substantial equivalence to predicate devices. The "performance" is implicitly demonstrated by the successful completion of these tests.
Therefore, the table below will list the types of testing performed and the reported outcome.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| In Vitro/Bench Testing: | |
| Model 9525 implanted recorder testing (hybrid qualification, electromagnetic compatibility, mechanical, battery) | Passed all in vitro requirements. |
| Model 6190 Activator testing | Passed all in vitro requirements. |
| Package testing | Passed all in vitro requirements. (Both package configurations were fully validated.) |
| In Vivo Canine Testing: | |
| Comparison to surface ECG monitor | Data demonstrates the Reveal ILR system is safe and provides ECG information substantially equivalent to that provided by the surface monitor. |
| Comparison to competitive devices (Instromedix King of Hearts Express® 3X™, Instromedix HeartCard 3X™) | Data demonstrates the Reveal ILR system is safe and provides ECG information substantially equivalent to that provided by the cardiac event recorders. |
| Biocompatibility: | Not required as blood-contacting materials are the same as the predicate Medtronic Minix implantable pulse generator. |
| Sterilization Validation: | A process appropriate for sterilizing the Model 9525 implanted recorder (using 100% Ethylene Oxide (EtO)) was validated. |
| Overall Performance (Substantial Equivalence): | The testing provides reasonable assurance that the Reveal ILR system will perform as intended. Based on similarities in design, materials, in vitro test data, and canine in vivo electrical performance, Medtronic considers the Reveal ILR system to be substantially equivalent to the Instromedix King of Hearts Express 3X and the Medtronic Minix implantable pulse generator. |
Study Information Details
The provided 510(k) summary focuses on demonstrating substantial equivalence through in vitro and in vivo animal testing, rather than a clinical trial with human subjects from a "test set" in the typical sense for algorithm performance.
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Sample size used for the test set and the data provenance:
- In Vitro/Bench Testing: The sample sizes for these tests are not specified but would typically involve multiple units of each component (recorder, activator, packaging) tested under various conditions to ensure robustness and adherence to specifications. The data provenance is internal laboratory testing by Medtronic.
- In Vivo Canine Testing: "Two comparative studies of the Reveal ILR system were performed with canines." The exact number of canines is not specified. The data provenance is animal (canine) studies, presumably conducted by Medtronic or a contracted research organization.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the canine studies, the "ground truth" for ECG information was likely established by the "surface ECG monitor" used as a comparator device and interpreted by veterinary or medical professionals with expertise in cardiac electrophysiology, though their specific number and qualifications are not mentioned. For the bench testing, the ground truth would be engineering specifications and standards.
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Adjudication method for the test set:
- Not applicable as the reported studies are primarily technical performance evaluations and animal comparative studies, rather than human clinical trials requiring complex adjudication of diagnostic outcomes.
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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, an MRMC comparative effectiveness study was not done. This submission predates widespread AI integration in such devices and focuses on the fundamental function and safety of the recording system, not on human interpretation assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Reveal™ Insertable Loop Recorder" acts as a recording system. Its "performance" is in accurately capturing and storing ECG data. The device itself (the implanted recorder) and its associated software for displaying waveforms do not appear to have an independent "algorithm" for automated diagnosis or interpretation. Its function is to provide raw ECG data for a clinician to analyze. Therefore, a standalone algorithm performance study, as understood in an AI context, is not applicable. The device's 'standalone' performance is its ability to record and store ECG signals reliably.
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The type of ground truth used:
- In vitro/Bench Testing: Engineering specifications, industry standards, and functional requirements.
- In vivo Canine Testing: The ground truth for the ECG information was established by simultaneously recorded data from a "surface ECG monitor" which serves as a established standard for cardiac electrical activity.
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The sample size for the training set:
- Not applicable. This device is a diagnostic recording system, not a machine learning algorithm that requires a "training set" in the AI sense. Its development would involve engineering design, manufacturing standards, and rigorous testing on physical devices.
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How the ground truth for the training set was established:
- Not applicable, as no training set for an AI algorithm was involved.
§ 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).