(106 days)
The Liberty System, when used with Audicor Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians.
The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; or as a stand-alone electrocardiograph. The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician, and is for use on adults (>= 18 years).
The Liberty System is a pocket PC-based device that that can be used to allow clinicians access to the COR (correlated audioelectric cardiography) report including graphical display of MI, Ischemia, and LVH conditions as well as display of heart sound waveforms and identification of S3 and S4 heart sounds.
Here is an analysis of the provided text regarding the Liberty System, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device's diagnostic performance and its reported performance against those criteria. Instead, the "Test Summary & Conclusion" section focuses on compliance with established safety and electrical standards.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| Safety and Electrical Standards Compliance | • ANSI/AAMI EC-11 Standard for Diagnostic Electrocardiographic Devices | Shown to comply |
| • ANSI/AAMI EC 53 ECG Cables and Leadwires | Shown to comply | |
| • EN 60601-1-2 Standard for Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | Shown to comply | |
| • IEC 60601-2-25 Medical Electrical Equipment Part 2: Particular requirements for the safety of electrocardiographs | Shown to comply | |
| • UL 60601-1 Standard for Medical Electrical Equipment: General Requirements for Safety | Shown to comply | |
| Technological Equivalence to Predicate Device | • Acquire 12 lead ECG and heart sounds data from adult patients | Stated to be technologically equivalent to predicate device |
| • Present data in COR report format | Stated to be technologically equivalent to predicate device | |
| • Include graphic display of MI and LVH conditions | Stated to be technologically equivalent to predicate device | |
| • Detect and display S3 and S4 heart sounds | Stated to be technologically equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's diagnostic performance or its ability to identify MI, Ischemia, LVH, S3, or S4 heart sounds. The "Test Summary & Conclusion" refers to compliance with performance standards (like ANSI/AAMI EC-11), which typically involve electrical and functional testing, not clinical diagnostic accuracy studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As no specific test set for diagnostic performance is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. The focus is on the device's ability to acquire and interpret data for physician consideration, but not on a comparative study of physician performance.
6. Standalone (Algorithm Only) Performance Study
While the device's description mentions it "provides interpretation of the data," and "interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read," the document does not present any standalone performance study data (e.g., sensitivity, specificity, accuracy) of the algorithm's interpretation capabilities without human-in-the-loop performance. Its primary claim of equivalence is based on technological characteristics to a predicate device, not on independent diagnostic performance metrics.
7. Type of Ground Truth Used
Given the lack of a described diagnostic performance study, the document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The evaluation appears to be based on compliance with electrical and functional standards and technological equivalence, rather than clinical diagnostic outcome agreement.
8. Sample Size for the Training Set
The provided document does not mention any training set size for the device's algorithms or interpretation capabilities. This implies either that the device uses rule-based algorithms or that any training data used for its interpretation models was not deemed relevant for this 510(k) submission, which focuses on technological equivalence and compliance with established product standards.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is also not provided.
§ 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).