(107 days)
The MAC 800 is a portable ECG acquisition, analysis and recording system.
The MAC 800 is intended to be used under the direct supervision of a licensed healthcare practitioner.
The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics and physician offices outreach centers to record ECG signals from surface electrodes.
The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.
The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.
The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional.
The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation.
The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement It can be upgraded to provide options such as ECG measurement and interpretation with 12SL. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.
The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non-real time reports. The device can print the resting ECG report via the external laser printer including USB laser printer and network laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.
This document is a 510(k) premarket notification for the GE MAC 800 Resting ECG Analysis System (MAC 800V2). It largely focuses on demonstrating substantial equivalence to a predicate device (MAC 800V1) and other GE algorithms (MUSE and 12SL ECG Analysis Program), rather than presenting a standalone study with detailed acceptance criteria and performance data.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, and ground truth establishment are not directly available in the provided text.
Based on the available information, here's what can be extracted:
Acceptance Criteria and Device Performance (Not fully detailed as it's a substantial equivalence submission)
The document asserts "The design changes made have no effect on the device's ability to acquire and analyze ECG data" and that the MAC 800V2 is "as safe, as effective, and performance is substantially equivalent to the predicate devices." This implies that the acceptance criteria are met if the new device's performance is deemed equivalent to the previously cleared predicate.
Explicit Acceptance Criteria: Not stated for specific performance metrics in this document. The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.
Reported Device Performance: Not quantified in this document. The document states that the proposed MAC 800V2 uses the "identical 12SL ECG algorithm (K060833)" and has "identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212)". This implies that the performance is expected to be the same as the predicate and the 12SL algorithm.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for quantifiable device performance metrics in this 510(k) submission. Instead, the primary "acceptance criterion" is the demonstration of substantial equivalence to the predicate device and the use of identical, previously cleared algorithms and functionalities. | The MAC 800V2 employs the "identical 12SL ECG algorithm (K060833)" and provides "identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212)." Therefore, its performance is expected to be consistent with these previously cleared components. |
Study Details (Based on available information)
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in this document, as a new clinical study to evaluate the device's performance against specific acceptance criteria was not required for this submission. The submission relies on substantial equivalence to previously cleared devices and algorithms.
- Data Provenance: Not specified. The document indicates that the 12SL ECG algorithm (K060833) is used, and the predicate device is MAC 800V1 (K090212). The performance of these previously cleared components would have been established in their respective submissions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified or applicable in this 510(k) submission, as it did not require new clinical studies. The ground truth for the 12SL ECG algorithm (K060833) would have been established during its original clearance process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified or applicable, as no new clinical study was conducted for this submission.
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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 MRMC study was done for this specific submission. The document explicitly states: "The subject of this premarket submission, the proposed MAC 800V2 did not require clinical studies to support substantial equivalence." The device is an ECG analysis system, which may or may not involve AI in the way a modern "AI assistance" study would assess. The 12SL algorithm performs "interpretive analysis," which could be considered an automated interpretation, but the document does not focus on human reader improvement with or without this analysis in this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly described as a new standalone performance study for the MAC 800V2.
- However, the document states the device "uses identical 12SL ECG algorithm (K060833)." The 12SL algorithm itself is a standalone interpretive algorithm. Performance data for that algorithm would have been part of its original 510(k) submission (K060833). This current submission implicitly leverages the established standalone performance of the 12SL algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified for this submission. For ECG interpretation algorithms like 12SL, ground truth is typically established by expert consensus of cardiologists on ECG recordings, sometimes correlated with clinical outcomes or other diagnostic tests, as would have been done in the K060833 submission.
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The sample size for the training set:
- Not specified in this document. This submission focuses on a new version of hardware/software based on existing algorithms. The training set for the underlying 12SL ECG algorithm (K060833) would have been described in its original submission.
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How the ground truth for the training set was established:
- Not specified in this document. Similar to the test set, the ground truth for the training of the 12SL algorithm (K060833) would have been established through a rigorous process, likely involving expert cardiologists' interpretations and adjudication, as is standard for ECG algorithms.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).