(309 days)
- The device is for prescription use only.
- The device is intended to be used in a clinic or hospital.
- The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG.
- The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station.
- In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.
Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port.
Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module:
- An analog front end.
- Digital Signal Processing USB Interface Unit.
- TTM Interface for analog phone lines.
- TTM Interface for digital phones.
The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).
The provided document is a 510(k) summary for the Cygnus 12 Lead/TTM ECG Module. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain explicit acceptance criteria or a detailed study report that would typically prove a device meets specific performance metrics.
Instead, the summary states:
"The device was tested in accordance with applicable sections of AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices and AAMI/ANSI EC 38: 1998, Ambulatory Electrocardiographs."
This indicates that the device's performance was evaluated against the standards outlined in these AAMI/ANSI documents, which would inherently contain performance requirements and testing methodologies for ECG devices. The "Summary of testing" section broadly states this, and the "Conclusion" relies on functional similarities with the predicate device (K915632) to establish substantial equivalence.
Without access to the actual test reports or the specific sections of the AAMI/ANSI standards that Cygnus LLC applied and measured against, a detailed table of acceptance criteria and reported device performance cannot be generated from this document alone.
Therefore, many of your requested points cannot be extracted directly from this 510(k) summary. I will answer what is available and indicate when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit acceptance criteria and corresponding reported performance are not detailed in this 510(k) summary. The document states compliance with AAMI/ANSI EC 11: 1991 and AAMI/ANSI EC 38: 1998. These standards would contain the acceptance criteria for diagnostic and ambulatory ECG devices, respectively. Without access to these standards and Cygnus's specific test reports, a detailed table cannot be created.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document only mentions that the device was "tested in accordance with applicable sections" of the AAMI/ANSI standards, but provides no specifics about the test set, sample size, or data provenance.
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)
This information is not provided in the 510(k) summary, as it does not detail the specific testing methodology for establishing ground truth or the involvement of experts in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not described or referenced in this 510(k) summary. This device is a measurement and monitoring system, not an AI-assisted diagnostic tool in the typical sense that would necessitate such a study (i.e., it's not performing diagnostic interpretation that would then be compared to human readers).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The 510(k) summary describes a "fully functional ECG and Pacemaker monitoring system." The testing mentioned (AAMI/ANSI EC 11 and EC 38) would evaluate the standalone performance of the device's measurement capabilities (e.g., accuracy of ECG waveform acquisition, heart rate measurement, pacemaker pulse detection). While not explicitly stated as "standalone algorithm performance," the nature of these standards implies testing the device's technical specifications and measurements without a human interpreting the device's output to influence the device's function or measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth used." For a device measuring ECG signals and detecting pacemaker activity, the ground truth would typically be established through:
- Reference standard equipment: Comparison to known, calibrated, and highly accurate ECG and pacemaker simulators or other established reference devices.
- Physiological recordings: In some cases, recordings from human subjects or animal models where true physiological events are simultaneously measured by gold-standard methods, although the AAMI/ANSI standards primarily focus on technical performance.
Given the nature of the device and the standards cited, the ground truth would likely involve a combination of precise electrical signals, simulated ECGs, pacemaker pulses, and potentially recordings validated against professional interpretation or other highly accurate monitoring equipment.
8. The sample size for the training set
This device is not presented as an AI/machine learning model requiring a "training set" in the conventional sense. Therefore, this information is not applicable and not provided. The device's performance would be based on its engineering design, hardware, and algorithms for signal acquisition and processing, evaluated against technical standards.
9. How the ground truth for the training set was established
As the device is not an AI/machine learning model with a "training set," this question is not applicable.
§ 870.3640 Indirect pacemaker generator function analyzer.
(a)
Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.(b)
Classification. Class II (performance standards).