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510(k) Data Aggregation
(241 days)
Indications for Use:
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
- 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.
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.
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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(146 days)
The ECG-AI LEF 12-Lead algorithm is software intended to aid in earlier detection of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40% in adults at risk for heart failure. This population includes, but is not limited to:
- patients with cardiomyopathies
- patients who are post-myocardial infarction
- patients with aortic stenosis
- patients with chronic atrial fibrillation
- patients receiving pharmaceutical therapies that are cardiotoxic, and
- postpartum women.
The ECG-AI LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions, should not be used for monitoring of patients, and should not be used on ECGs with a paced rhythm.
A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out further non-invasive evaluation.
The ECG-AI LEF 12-Lead Algorithm should be applied jointly with clinician judgment.
The ECG-AI LEF 12-Lead algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the third party software on a device such as a smartphone, tablet, or PC. The ECG-AI LEF 12-Lead algorithm was trained to detect Low LVEF using positive and control cohorts, and the detection of Low LVEF in patients is generated using defined conditions and covariates.
The ECG-AI LEF 12-Lead algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, frontline clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the ECG-AI LEF 12-Lead algorithm to aid in earlier detection of LVEF less than or equal to 40% and making a decision for further cardiac evaluation.
The software module can be integrated into a client application to be accessed by clinicians and results viewed through an Electronic Medical Record (EMR) system or an ECG Management System (EMS) accessed via a PC, mobile device, or another medical device. In each case, the physician imports 12-lead ECG data in digital format. The tool analyzes the 10 seconds or longer duration of voltage data collected during a standard 12-lead ECG and outputs a binary result of the likelihood of low ejection fraction as an API result.
The provided text is a 510(k) clearance letter and summary for the Anumana, Inc. ECG-AI Low Ejection Fraction (LEF) 12-Lead Algorithm ([K250652](https://510k.innolitics.com/device/K250652)). While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain the detailed performance study results, acceptance criteria tables, sample sizes, or ground truth establishment methods that would typically be found in the clinical study section of a full 510(k) submission.
The document discusses a "Predetermined Change Control Plan (PCCP)" which mentions future performance enhancement validation studies, but it doesn't present the specific results of the validation study that led to this clearance ([K250652](https://510k.innolitics.com/device/K250652)). It only states that "The performance characteristics for the ECG-AI LEF 12-Lead algorithm were evaluated through software verification and labeling verification," which refers to non-clinical data.
Therefore, many of the requested details cannot be extracted from the provided text. I will populate the table and answer the questions based only on the information available in the given document.
Acceptance Criteria and Device Performance Study (Extracted from provided 510(k) Summary)
The provided 510(k) summary (K250652) serves as an update to a previously cleared device (K232699). It focuses on expanding compatibility and minor changes, asserting substantial equivalence based on the predicate's performance rather than detailing a new, comprehensive clinical study for this specific submission. The document emphasizes "software verification and labeling verification" as the evaluation methods for performance characteristics for this particular submission, rather than a clinical performance study with specific metrics for acceptance criteria.
The Predetermined Change Control Plan (PCCP) section alludes to future performance enhancements and their validation, stating: "To be implemented, a modified version must demonstrate improved performance by meeting pre-specified acceptance criteria. These criteria require the new version's sensitivity and specificity point estimates to be greater than or equal to the previous version, with an improvement shown by either an increased point estimate or a tighter confidence interval lower bound for at least one of these metrics." However, these are future criteria for updates, not the current acceptance criteria for the clearance of K250652 based on a new clinical study.
Therefore, the specific quantitative acceptance criteria and reported device performance for the clinical study supporting the K250652 clearance are not explicitly stated in the provided text. The clearance is largely based on demonstrating substantial equivalence to the predicate (K232699) and software/labeling verification.
Based on the provided text, the specific details regarding the clinical performance study (including acceptance criteria, reported performance values, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the test set) are NOT available.
1. A table of acceptance criteria and the reported device performance
As noted above, the provided text does not contain a table of explicit quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) from a clinical study for K250652. The document claims "The performance characteristics for the ECG-AI LEF 12-Lead algorithm were evaluated through software verification and labeling verification" for this submission, indicating that a new, detailed clinical performance study with such metrics was not the basis for this specific clearance. The PCCP section specifies criteria for future updates, but not for this clearance.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative Performance Metrics (e.g., Sensitivity, Specificity, AUC) | Not specified in the provided document for this clearance (K250652). The PCCP mentions that future updates must show sensitivity and specificity point estimates $\ge$ previous version, or improved confidence interval. | Not specified in the provided document for this clearance (K250652). The clearance is based on substantial equivalence to a predicate and non-clinical verification. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The PCCP mentions "multi-center retrospective clinical study" for future validations, but this isn't linked to the original clearance's test set.
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)
- Not specified in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified in the provided 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
- Not specified in the provided document. The current indication is "to aid in earlier detection" and "applied jointly with clinician judgment," which implies human-in-the-loop, but an MRMC study comparing performance with and without AI assistance is not detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document states: "The ECG-AI LEF 12-Lead algorithm is not intended to be a stand-alone diagnostic device for cardiac conditions," and "should be applied jointly with clinician judgment." This implies the device is not intended for standalone use in practice. However, whether a standalone performance study was conducted to assess its raw diagnostic capability (e.g., area under the curve) is not explicitly stated. The statement "outputs a binary result of the likelihood of low ejection fraction as an API result" suggests a standalone algorithm output, but the FDA's clearance is for an "aid," not a primary diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document mentions the device "was trained to detect Low LVEF using positive and control cohorts." For LVEF, the common ground truth is often echocardiography (measuring ejection fraction), but the specific method used for ground truth (e.g., echocardiography, MRI, or a combination/adjudication) is not specified.
8. The sample size for the training set
- Not specified in the provided document.
9. How the ground truth for the training set was established
- The document states the device "was trained to detect Low LVEF using positive and control cohorts," but it does not describe how the ground truth was established for these training cohorts (e.g., type of diagnostic test, clinical adjudication process).
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