(28 days)
The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters when decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment.
The Heartline is an ECG monitoring device intended to receive ECG signals over standard telephone lines from patient operated transmitters. When decoded, received signals are recorded and patient data can be displayed on a PC monitor for physicians analysis and comment. The HRS is basically a software system, and operates on commercial personal computers. The device is compatible with all Aerotel monitors, all of which have been cleared by the FDA.
The provided text describes a 510(k) submission for the Aerotel Medical Systems "Heartline Receiving Station". However, it explicitly states that clinical tests were "Not required" and no specific acceptance criteria or performance studies were conducted to prove the device meets such criteria.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided, as clinical tests were not required. The submission only states the device was "thoroughly verified and validated" and the system "has been validated" but no performance metrics are given.
- Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
- Adjudication method for the test set: Not applicable as no clinical test set was used.
- 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: Not applicable as no clinical study was done and this device is described as a "software system" that displays data for "physicians analysis and comment," not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance study was done.
- The type of ground truth used: Not applicable as no clinical performance study was done.
- The sample size for the training set: Not applicable as no machine learning algorithm is described as being trained in a clinical context. The device is a "software system" for receiving and displaying ECG signals, not an AI model requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Basis for Acceptance:
The submission for the Heartline Receiving Station relies on non-clinical tests and substantial equivalence to a legally marketed predicate device (Aerotel Heartline receiving Console, K930314, cleared by FDA in 1993) rather than a clinical performance study with defined acceptance criteria.
- Non-clinical tests: "The programs for the Heartline Receiving Station have been thoroughly verified and validated. The recommended computers meet international standards for electrical safety and electronic emissions. The entire system has been validated."
The FDA's decision to clear the device (K022073) was based on a finding of substantial equivalence to this predicate device, which implies that the new device is as safe and effective as the predicate and shares the same indications for use. The FDA letter confirms, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
Therefore, the "acceptance criteria" were met by demonstrating that the device's design, software functionality, and intended use were comparable to an already cleared device, along with verification and validation of its non-clinical aspects (software programs, electrical safety, emissions). No specific performance metrics for diagnostic accuracy or clinical outcomes are provided or required in this submission context.
§ 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).