(272 days)
The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited by the physician. The program is intended for use by qualified healthcare professionals and other healthcare facilities for the assessment of common cardiac abnormalities, including arthythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.
The AI-ECG Platform (S Edition) is a software package which is a distributed ECG auto analysis system designed to assist physician in measuring and interpreting 12-lead resting ECG with AI algorithm, the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
The Carewell AI-ECG Platform is intended to be used in conjunction with Carewell ECG device or compatible ECG can export Carewell proprietary ECG data, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. The program receives ECG waveform data direct from device or user manually uploaded, analyzes ECG data and automatically interprets on the computer server, the ECG measurement, interpretation and waveform data are then downloaded to a PC based physician's diagnosis client application to allow physician review, modify and confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the server computer securely.
While the provided text describes the AI-ECG Platform and its substantial equivalence to predicate devices, it does not contain the detailed information required for an acceptance criteria table and the specific study proving the device meets those criteria, as outlined in the request.
The document primarily focuses on regulatory approval (510(k) submission), product description, and a high-level comparison to predicate devices, discussing:
- Indications for Use: The intended purpose of the device.
- Device Description: How the software functions.
- Comparison to Predicates: Highlighting similarities in product codes, regulations, classification, and fundamental technology.
- Non-Clinical Test Conclusion: Mentioning compliance with standards like AAMI ANSI EC57 for performance results and IEC 60601-2-25 for safety.
However, the document is missing specific performance metrics and the detailed study design elements you requested, such as:
- A table of acceptance criteria with reported device performance: While AAMI ANSI EC57 is mentioned for performance, the actual criteria (e.g., sensitivity, specificity for specific cardiac abnormalities) and the results achieved are not provided.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Details of any MRMC comparative effectiveness study, including effect size.
- Standalone (algorithm-only) performance metrics.
- The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Without this specific information in the provided text, I cannot construct the requested table or describe the study in detail. The document states that "Bench test were conducted to verify that the subject device met all design specifications," but it does not elaborate on these specifications or the results of these tests in a quantifiable manner relevant to acceptance criteria.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).