(29 days)
The Medtronic Reveal Plus Insertable Loop Recorder is an implantable patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.
The Reveal Plus ILR system is designed to record and store electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9526 implanted recorder and the Model 6191 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9809E software is required for programming and retrieving data from the recorder.
The primary new feature of the Reveal Plus ILR is the auto-activation function, which supplements the patient-activated function. Patient activation remains the primary means to capture an event. Patient activation is important to document the patient's ECG when either an arrhythmic or non-arrhythmic event occurs, providing the clinician with a symptom-rhythm correlation. Storage of a patient-activated event with normal sinus rhythm helps the physician to rule out arrhythmic causes. Auto activation may be useful for patients who may be incapable of using the patient Activator or who are otherwise noncompliant.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Reveal Plus Insertable Loop Recorder:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text focuses on the device's substantial equivalence to a predicate device by highlighting similarities and conducting specific tests. It doesn't explicitly state quantitative acceptance criteria in a formal table with corresponding performance metrics for the new features. Instead, it emphasizes passing various in vitro and in vivo tests to demonstrate the device meets design and performance requirements.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of equivalence and successful testing. The primary new feature is "auto-activation."
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Integrity: Device structure is mechanically sound and robust. | Passed all in vitro requirements. (Mechanical, battery, and package testing not repeated as it uses identical platform to predicate) |
| Battery Performance: Battery life meets specifications. | Passed all in vitro requirements. (Battery testing not repeated as it uses identical platform to predicate) |
| Package Integrity: Packaging effectively protects the device and maintains sterility. | Passed all in vitro requirements. (Package testing not repeated as it uses identical platform to predicate; Both package configurations fully validated) |
| Hybrid Qualification: Electronic components and integrated systems function as intended. | Passed all in vitro requirements (Model 9526 implanted recorder testing). |
| Electromagnetic Compatibility (EMC): Device operates without interference and is not susceptible to external electromagnetic fields. | Passed all in vitro requirements (Model 9526 implanted recorder testing). |
| Activator Functionality: Model 6191 Activator functions correctly. | Passed all in vitro requirements (Model 6191 Activator testing). |
| Auto-activation Feature Functionality: The auto-activation feature correctly identifies and records cardiac events, with acceptable levels of false activations. | Evaluated in a canine study. "False activations were evaluated before and after adjustments to the sensitivity setting." (Implies successful adjustment to meet an acceptable level, though specific metrics are not given). |
| Biocompatibility: Device materials are not harmful to biological tissues. | Not required for new testing; identical blood-contacting materials as the predicate device. |
| Sterilization Efficacy: Sterilization process effectively renders the device sterile. | Validated; identical EtO sterilization process to predicate device (Model 9525). |
| Overall Performance as Intended: Device performs as described in its labeling when used as intended. | "The testing described above provides reasonable assurance that the Reveal Plus ILR system will perform as intended when used in accordance with its labeling." |
| Substantial Equivalence: The Reveal Plus ILR system is as safe and effective as the predicate Reveal ILR system. | "Medtronic considers the Reveal Plus ILR system to be substantially equivalent to the Reveal ILR system." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (In Vivo): Not explicitly stated as a number of animals, but a "canine study" was performed.
- Data Provenance: The study was an "in vivo" test using "canine" subjects. The text does not specify the country of origin, but it is a Medtronic, Inc. product from Minneapolis, MN, USA. The study design appears to be prospective, specifically designed to evaluate the new auto-activation feature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of human experts to establish ground truth for the canine study. The evaluation of "false activations" suggests a direct measurement against a predefined criterion for true activation.
4. Adjudication Method for the Test Set:
- No information is provided regarding an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The study focused on the functional performance of the auto-activation feature in animals, not on human reader performance with or without AI assistance.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
- Yes, the canine study to evaluate the auto-activation feature can be considered a standalone study for that specific algorithm's performance. The "false activations were evaluated before and after adjustments to the sensitivity setting," indicating an assessment of the algorithm's accuracy in identifying events without human intervention during the event capture process.
7. The Type of Ground Truth Used:
- For the canine study evaluating auto-activation: The ground truth appears to be based on physiological events in the canines, against which the device's auto-activation was compared. The "false activations" imply there was a gold standard or a defined truth for what constituted a "true" activation, likely derived from other monitoring equipment or expert observation of the canine's cardiac activity.
8. The Sample Size for the Training Set:
- The document does not provide information about a separate training set. This is a premarket notification for a hardware device with a new software feature (auto-activation). While the auto-activation algorithm might have involved internal development and testing, details about training data for a machine learning model are not disclosed, nor is it explicitly indicated that such a model was used. The adjustments to "sensitivity setting" suggest a rule-based or threshold-based algorithm rather than a complex AI model requiring extensive training data in the modern sense.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided as no specific training set and ground truth establishment method are mentioned. If the "sensitivity setting" was optimized, it would likely have been adjusted based on data from internal development or preliminary testing, where ground truth would have been established by direct observation or more comprehensive physiological monitoring.
§ 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).