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The device is indicated for use to acquire, analyze, display and print electrocardiograms.
The device is indicated for use to provide interpretation of the data for consideration by a physician.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Intended Use:
The MAC 7 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional.

The MAC 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional's facility or wherever ECG testing is performed.

Device Description

The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.

The device can capture 3, 6, 12 or 15 lead electrocardiograms, provide interpretive analysis, and print reports.

The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.

The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

AI/ML Overview

The FDA 510(k) clearance letter for the MAC 7 Resting ECG Analysis System (K251670) does not contain a specific study proving the device meets acceptance criteria. Instead, it establishes substantial equivalence to predicate devices (K203786, K173830, K210560) based on similarities in intended use, indications for use, technology, and performance, along with compliance with voluntary standards and non-clinical testing.

Therefore, the following information is extracted from the provided text to fulfill your request:

1. Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and compares them to predicate devices, demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. The "Discussion of Differences" column often highlights that a change does not significantly affect substantial equivalence, implying that the performance remains acceptable.

Specification	Predicate Product: MAC 7 Resting ECG Analysis System (K203786)	Proposed Product: MAC 7 Resting ECG Analysis System	Reported Device Performance (as implied by "Discussion of Differences")
Intended Use	As described in the predicate	As described in the proposed product	Equivalent: "The change in the intended use statement reflects the flexibility of the system without impacting the core functionality or safety profile." and "The change in the intended use statement doesn't alter the substantial equivalence of the device."
Indications for Use	As described in the predicate	As described in the proposed product	Equivalent: "The updated language to include healthcare practitioner broadens the description to reflect current clinical practices without altering the device's safety or performance."
Contraindications	As described in the predicate	As described in the proposed product	Identical
Patient Population	Adult and pediatric (birth through 21 years of age), with ACS interpretation exception < 16 years.	Adult and pediatric (birth through 21 years of age), with Lead reversal detection exception ≤ 15 years and ACS interpretation exception < 16 years.	Substantial Equivalent: "The subject device maintains full alignment with the adult and pediatric patient population indications of the predicate and reference devices." and "Age-related limitations for Lead Reversal Detection and ACS interpretation are consistent with those of the predicate/reference devices and do not alter the overall patient population equivalence."
Environment of Use	As described in the predicate	As described in the proposed product	Identical
Patient Acquisition Circuitry	Integrated in the device, digitalizing functions provided by the device.	Integrated in the device, digitalizing functions provided by the device.	Identical (for comparison with MAC 7 predicate); Equivalent: "The proposed device uses the same acquisition module as the reference device. The only difference is that the proposed product uses a standard USB port. These differences do not affect the substantial equivalence of the device." (for comparison with MAC VU360 reference)
Interpretive ECG Analysis	Yes	Yes	Identical
Critical Values	Identified, indicated via dialog box and printed report; user acknowledgement required.	Identified, indicated via dialog box and printed report; user acknowledgement required.	Identical
ECG Pacemaker Detection and HD Pace	Digital detection, separate printable/viewable channel; 12SL disabled for acquisition module detections.	Digital detection, separate printable/viewable channel (configurable on/off, default enabled); 12SL disabled for acquisition module detections.	Substantial Equivalent: "The change involves adding the ability to configure the separate pacemaker pulses channel to enable or disable detection, with the default setting being enabled. This modification provides additional flexibility without affecting the device's core functionality or safety."
Frequency Response	0.04 to 150Hz	0.04 to 300Hz (default 0.04 to 150Hz)	Equivalent: "The proposed product expands bandwidth support from 150 to 300Hz as included in the K221321. There was no change in measurements or accuracy... The difference does not significantly affect substantial equivalence."
Prior ECG	Not supported	Download, review, print recent previous ECG from same patient.	Equivalent: "The proposed MAC 7 can download the most recent previous ECG from the ECG management server for the same patient. This change has been verified to not significantly impact substantial equivalence." (for MAC 7 predicate); Equivalent: "The design of the Prior ECG feature uses current patient identification to query historical ECG data from the management system, enabling the retrieval and comparison of the most recent previous ECG with the current one from the same patient. The output of this process is consistent between the proposed and reference device. The only notable difference is in the labelling of the printed report, where MAC 7 V2 displays "Prior ECG" while TC30 uses "Previous ECG"... The labelling difference does not alter the functionality, or performance of the feature. Therefore, the addition of this feature does not impact the substantial equivalence of the proposed device." (for TC30 predicate)
Display type, size, resolution, and information	10 inch diagonal LCD, 1280 x 800, displays patient name, lead label, patient I.D., heart rate, date/time.	10 inch diagonal LCD, 1280 x 800, displays patient name, lead label, patient I.D., heart rate, date/time.	Identical
Battery Operation	Rechargeable and user replaceable	Rechargeable and user replaceable	Identical
Recorder Method	Thermal dot array	Thermal dot array	Identical
Number of Channels	Selectable 3, 6, or 12 channels + pace annotation	Selectable 3, 6, 12 or 15 channels + pace annotation	Equivalent: "The proposed device supports up to 15 channels due to the addition of three more electrodes and their corresponding signal acquisition."
Thermal Paper size	A4 or Letter format, thermal paper Z-fold	A4 or Letter format, thermal paper Z-fold	Identical
Network Printer Option	Not supported	Support to print report via network printer	"The contents of the network printer reports are the same as thermal printer reports." (Implies acceptable performance by producing identical reports)
eDelivery	Not supported	Support for self-registration, activation, and software update notifications.	"This is a service feature which make it easier to deliver new software version to customer, it does not affect substantial equivalence." (Implies acceptable performance as it doesn't impact core function)
RSvP	Not supported	Support to upload service snapshot to remote server.	"This is a service feature which make it easier to get device data for trouble shooting, it does not affect substantial equivalence." (Implies acceptable performance as it doesn't impact core function)
Interpretation Statements	12SL™ analysis algorithm (v23.1) for 10 seconds ECG.	12SL™ analysis algorithm (v24) for 10 seconds ECG.	Equivalent: "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321... The difference does not significantly affect substantial equivalence." (Implies performance is acceptable as per prior clearance)
Lead Reversal Detection	Limb lead reversal detection	Limb lead and chest lead reversal detection.	Equivalent: "The primary change involves an algorithm update from 12SL (v23.1) to 12SL (v24), which allows the detection of additional lead reversals without altering the core substantial equivalence of the device. The MAC 7 interface presents the new detection capability, without compromising the device's safety and performance."
Acute Coronary Syndrome (ACS)	Provides interpretation statement for ACS.	Provides interpretation statement for ACS.	Identical
Dimensions and Weight	40 x 32 x 21 cm, 5.2 Kg	40 x 32 x 21 cm, 5.2 Kg	Identical

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This indicates that no specific test set data from clinical studies was used for performance evaluation in this submission. The "acceptance" is based on the device's technical characteristics aligning with or improving upon those of legally marketed predicate devices, supported by non-clinical testing and previous clearances for core components (like the 12SL™ analysis algorithm v24).

Therefore, details on sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

As no clinical studies were required for this submission to support substantial equivalence, there is no information provided regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Given that no clinical studies were performed, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness study. The focus is on establishing substantial equivalence to existing devices, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The document states that the "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321." This implies that the performance of the 12SL™ algorithm itself (a standalone interpretation algorithm) would have been assessed during its prior clearance (K221321). However, the details of that standalone performance study are not included in this K251670 submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no new clinical studies were performed for this submission, there is no mention of the type of ground truth used for a test set. For the 12SL™ analysis algorithm (v24) which provides interpretation statements, the ground truth would have been established during its prior clearance (K221321), but those details are not provided here.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for any training set. As noted, the approval is based on substantial equivalence and non-clinical testing rather than specific training data for a new algorithm.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how ground truth was established for any training set.

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