(26 days)
The HeartOne is intended to be used as a Patient/physician activated single lead ECG data recorder/transmitter, for recording ECGs and transmitting them over telephone lines to Aerotel's Heartline Receiving Station
The unit is indicated whenever it is desired to have single-lead electrocardiograms of a patient. There are no known contraindications.
The HeartOne is a battery-powered ECG event recorder and transmitter that is capable of recording and storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station.
The HeartOne is a battery powered post-event ECG Event Recorder and Transmitter which is intended to be used by the patient to record portions of a patient's electrocardiogram (ECG) and to send it to a receiving center such as the Aerotel Heartline Receiving Station K022073 or equivalent.
The provided document is a 510(k) summary for the Aerotel Medical Systems (1998) Ltd. HeartOne Cardiac Event Recorder. It describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, sample sizes for training/test sets, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract the relevant information from the document regarding the device's performance validation.
Here's the information that can be extracted, and where the requested AI-specific information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical safety (IEC 601-1) | Validated by repeating IEC 601-1 tests. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Electromagnetic compatibility (IEC 601-1-2) | Validated by repeating IEC 601-1-2 tests. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Electrical characteristics (EC38) | Validated by repeating the electrical characteristic tests of standard EC38. (Implies meeting the standard's requirements, though specific values are not provided.) |
| Clinical performance | No clinical tests were performed. The device relies on substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set was used for this device for performance evaluation in the context of an AI model. The validation was based on non-clinical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth established by experts in the context of AI model evaluation. The non-clinical tests rely on established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication was used.
5. 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. This is a medical device, not an AI algorithm for diagnostic assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated based on its ability to record and transmit ECGs, not on an algorithm's diagnostic capabilities.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by adherence to established engineering standards such as IEC 601-1, IEC 601-1-2, and EC38.
8. The sample size for the training set
- Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or training set described in this document.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).