(387 days)
Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines.
Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.
Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document (K071130) describes the Heartrak Smart AF device, a transtelephonic cardiac event recorder with an added module for Atrial Fibrillation (AFib) detection.
Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it indicates that the device's performance was evaluated against established standards and protocols. The core implicit acceptance criterion is that the AFib detection module, when added to the existing device, performs according to these standards, and that there are no new issues of safety or effectiveness compared to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with standard evaluation protocols for cardiac rhythm detection, including ANSI/AAMI EC38:1998; IEC 60601-1; IEC 61000-4, and ANSI/AAMI EC57:1998/R2003. | "Testing was performed in compliance with standard evaluation protocols." The AFib detection module was tested using available annotated MIT-BIH AFIB database and MIT-BIH Arrhythmia database (Series 100 and Series 200). Performance statistics were derived. |
| No significant differences in technological characteristics compared to the predicate device. | "The testing included in our submission... demonstrates that there are no differences in the technological characteristics of the subject device and the predicate device." |
| No new issues of safety or effectiveness. | "therefore there are no new issues of safety or effectiveness." |
| Substantial equivalence to the predicate device (Heartrak Smart AT). | "The Heartrak Smart AF is substantially equivalent to the predicate device, Heartrak Smart AT." |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "available annotated MIT-BIH AFIB database and MIT-BIH Arrhythmia database (Series 100 and Series 200)". The exact number of recordings or patients from these databases used in the test set is not specified in the provided text.
- Data Provenance: The MIT-BIH databases are widely recognized, publicly available databases of physiological recordings. They are derived from various sources, typically from multiple medical centers, and thus generally represent data from different countries (primarily the US for the MIT-BIH databases). The document does not specify the country of origin. The data is retrospective, as it refers to existing and curated databases.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the databases used are "annotated". This implies that expert review was performed during the creation of these databases to establish ground truth. However, the number of experts or their specific qualifications for the annotation of the MIT-BIH databases are not detailed in this submission.
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Adjudication method for the test set:
- The document does not describe the adjudication method specifically for the Heartrak Smart AF's use of the databases. The "annotation" of the MIT-BIH databases typically involves expert review, but the specific adjudication protocol (e.g., 2+1, 3+1) used during their original creation is not mentioned here.
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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. The Heartrak Smart AF is described as a device that converts ECG signals to audio tones for transmission. It "is not a diagnostic tool and performs no diagnostic functions," and the new AFib module is part of the internal firmware. The evaluation was a standalone algorithmic performance against a database, not an assessment of human reader improvement with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone algorithmic performance study was done. The text explicitly states, "The atrial fibrillation detection module was tested, using available annotated MIT-BIH AFIB database and MIT-BIH Arrhythmia database (Series 100 and Series 200)... to derive performance statistics for Heart Smart AF." This indicates direct evaluation of the algorithm against existing ground truth data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by expert consensus/annotation during the creation of the MIT-BIH AFIB and Arrhythmia databases. The term "annotated ECG databases" directly refers to expert-labeled data.
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The sample size for the training set:
- The document does not specify the sample size for the training set. It only mentions testing the AFib detection module. It is possible that the module was developed and possibly trained using parts of these same (or similar) public databases, but this is not explicitly stated, nor is the size of any training set.
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How the ground truth for the training set was established:
- Since the training set size and its specific source are not mentioned, how its ground truth was established is not provided in the document. If components of the MIT-BIH databases were used for training, their ground truth would also be expert annotation.
§ 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).