(54 days)
The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.
The mySense™ Heart, developed by Cardiac Science Corporation (CSC), is small, lightweight, patch-style cardiac monitor, designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 24 hours. The device system is composed of 2 main components:
- . Recorder - The mySense Heart recorder is about the size of a large band-aid and contains 2 electrodes that are used for sensing and detecting a patient's ECG. The recorder has an adhesive pad so that it can be attached to the patient's skin in the chest region for ECG collection.
- Recorder Processing Software (RPS) The RPS is installed on a . computer where the patient's ECG data on the recorder will be downloaded for subsequent analysis by ECG technicians/clinicians.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally states that "All testing demonstrated acceptable results." The primary method for demonstrating "acceptability" appears to be equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety (IEC 60601-1) | Demonstrated acceptable results |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Demonstrated acceptable results | |
| Biocompatibility (ISO 10993-1) | Demonstrated acceptable results | |
| Adhesive Performance (ANSI/AAMI EC12) | Demonstrated acceptable results in a clinical trial | |
| Effectiveness/Functionality | Design Verification | Demonstrated acceptable results |
| Software Verification and Validation | Demonstrated acceptable results | |
| Ambulatory ECG Data Collection (Equivalence to predicate) | "Substantially equivalent" to commercially available Holter ECG monitor (predicate) | |
| Clinical Performance | Comparative performance against a predicate device in cardiac subjects for ECG data collection accuracy | "Acceptable results" in a clinical trial of 50 cardiac subjects |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 50 cardiac subjects.
- Data Provenance: The document does not explicitly state the country of origin. It describes it as a "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects." This suggests a prospective clinical study setup.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide this information. It mentions "subsequent analysis by ECG technicians/clinicians" for the downloaded data, but it doesn't specify how ground truth for comparative testing was established (e.g., number of expert cardiologists interpreting the predicate device's data to serve as truth).
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size Improvements:
The document describes "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects," but this appears to compare the device's performance to a predicate device, not the human reader's performance with and without AI assistance. Therefore, an MRMC study related to AI assistance was not done, and no effect size for human reader improvement is stated. This device is a data acquisition device, not an AI-powered diagnostic tool in the sense of image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a recorder that collects ECG data. The "Recorder Processing Software (RPS)" is mentioned for "subsequent analysis by ECG technicians/clinicians." This implies that the device's primary function is data acquisition, and human review is part of the intended workflow. The "testing" section focuses on the device's ability to accurately record data and its adherence to various safety and design standards. While the RPS might have some automated processing, the core "performance" being evaluated seems to be the recording capability and equivalence to a Holter. Therefore, a standalone diagnostic algorithm performance study in the absence of human review does not appear to be the focus or explicitly detailed here.
7. The Type of Ground Truth Used:
The ground truth for the clinical comparative testing is implicitly the ECG data recorded by the predicate Holter monitor, which is considered the "gold standard" for ambulatory ECG recording in this context. The study compares the mySense™ Heart's recorded data to this established truth.
8. The Sample Size for the Training Set:
This information is not provided in the document. The device is a hardware recorder with associated software for processing, not a machine learning model that requires a "training set" in the conventional sense for deep learning. If there are internal algorithms within the RPS for artifact detection or basic rhythm classification, the training of such might not be detailed here.
9. How the Ground Truth for the Training Set was Established:
As no explicit "training set" and associated machine learning model development are described, this information is not applicable/provided.
§ 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).