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The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone.

The unit is indicated whenever it is desired to have electrocardiograms of a symptomatic patient at the time of the symptoms. There are no known contraindications.

The Heart 2006 is a battery-powered ECG event recorder and transmitter that is capable of storing an electrocardiogram and transmitting it by means of a telephone to a central receiving station. It records a portion of the ECG both before and after a "Record" button is depressed.

The H2006 is a battery powered 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 Aerotel's Heartline Receiving Station (FDA # K022073) or equivalent. It records portions of the ECG both before and after the Record button is depressed.

The provided text states that no clinical tests were performed for the Heart 2006 device. Therefore, a study proving the device meets acceptance criteria, as well as specific acceptance criteria related to clinical performance, a test set, expert involvement, and ground truth, cannot be described from this document.

The document indicates that the device's modifications were validated through non-clinical tests, specifically by repeating IEC 601-1 and IEC 601-1-2 tests (electrical safety and electromagnetic compatibility) and the electrical characteristic tests of standard EC38. The conclusion drawn from these non-clinical tests was that the Heart 2006 is equivalent in safety and efficacy to its predicate device, Heart 2005.

Since no clinical study was conducted, the following information cannot be provided:

1. A table of acceptance criteria and the reported device performance: No clinical acceptance criteria are mentioned, and no clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set existed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set existed, thus no ground truth establishment by experts.
4. Adjudication method for the test set: No clinical test set existed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No clinical study was performed, and the device is a hardware event recorder, not an AI algorithm.
7. The type of ground truth used: No clinical ground truth was established.
8. The sample size for the training set: The device is a hardware event recorder, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as detailed above.

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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

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.

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