(28 days)
The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems electrocatulographic information from lead. and potitution playsis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of upgraded to provide somnary of the electrocardiogram. Transmission and reception of ECG QRO and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.
The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The provided document for K014108 for the GE Medical Systems MAC 5000 ECG Analysis System is a 510(k) summary and FDA clearance letter, not a detailed study report. Therefore, it does not contain the specific information required to complete all sections of your request.
Here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary states that "Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness" and "The MAC 5000 complies with the voluntary standards as detailed in Section 9 of this submission," but it does not present specific acceptance criteria or performance metrics.
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 document.
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 document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is not mentioned and likely not applicable in this context as the device is for automated ECG analysis, not AI-assisted human reading. The document focuses on the device's own analytical capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is described as an "ECG Analysis System" that "acquire[s], analyze[s], display[s], and record[s] ECG signals." This implies standalone algorithm performance as its primary function. However, specific standalone performance metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of available information:
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed clinical performance study data with acceptance criteria or ground truth establishment. While it mentions internal quality assurance measures (Requirements specification reviews, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final system validation), these are development process descriptions, not performance study results.
§ 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).