(203 days)
The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.
The 12SL ECG Analysis Program is a software algorithm only.
The provided document is a 510(k) Premarket Notification Summary for the GE Healthcare 12SL ECG Analysis Program. It explicitly states that no clinical studies were required or performed to support substantial equivalence (K092369, Page 1). Therefore, the device does not have acceptance criteria and a study to prove it meets them in the conventional sense of a clinical trial demonstrating performance against predefined metrics.
The FDA cleared this device based on substantial equivalence to a predicate device (K060833; 12SL EGG Analysis Program with Right Ventricular Analysis) and non-clinical tests.
However, I can still extract the information relevant to understanding why no clinical study was deemed necessary and the basis for its clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics in the format of sensitivity, specificity, accuracy, etc., in this submission. The device's "performance" for regulatory purposes was assessed through its technological similarity to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no clinical test set was used for performance evaluation in this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set was used.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or required. The submission explicitly states, "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence" (K092369, Page 1).
6. Standalone Performance Study:
No standalone (algorithm only without human-in-the-loop performance) study was described in this submission, as clinical studies were not deemed necessary for substantial equivalence.
7. Type of Ground Truth Used:
Not applicable, as no clinical ground truth was established for a new performance study. The device's substantial equivalence relies on its underlying technology being the same as the predicate, which presumably had its performance established previously. The intended use specifies that "Interpretation by the product is then confirmed, edited, or deleted by the physician." This highlights that the device is an assistive tool, not a standalone diagnostic.
8. Sample Size for the Training Set:
Not applicable. The document does not describe the development or training of a new algorithm requiring a training set for this submission. The device employs "the same functional scientific technology as its predicate device" (K092369, Page 1).
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The document does not describe the development or training of a new algorithm for this submission.
Summary of Basis for Substantial Equivalence:
The 12SL ECG Analysis Program was deemed substantially equivalent based on:
- Technological Equivalence: It "employs the same functional scientific technology as its predicate device" (K092369, Page 1).
- Non-Clinical Tests: These included "Requirements Reviews, Risk Analysis, Software Verification and Validation, and Performance testing" (K092369, Page 1). These are internal quality assurance and engineering tests, not clinical performance studies.
- Predicate Device: The predicate device (K060833; 12SL EGG Analysis Program with Right Ventricular Analysis) was previously cleared, and this submission argues that the current device is equally safe and effective due to its similarity.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.