(127 days)
The 12SL ECG Analysis Program with Right Ventricular Analysis assists the physician in interpreting resting 12-lead ECGs for rhythms 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 patient's homes.
The 12SL ECG Analysis Program with Right Ventricular Analysis is a software algorithm only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 12SL ECG Analysis Program with Right Ventricular Analysis (K060833):
Acceptance Criteria and Device Performance Study for 12SL ECG Analysis Program with Right Ventricular Analysis (K060833)
Based on the provided 510(k) summary, specific, quantifiable acceptance criteria and a detailed study report are not explicitly provided. The submission focuses on substantial equivalence to a predicate device (K042177 MAC 5000 ECG Analysis System and K002209 12SL ECG Analysis Program) and compliance with voluntary standards.
The "Test Summary" section states: "The 12SL ECG Analysis System with Right Ventricular Analysis complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system: Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing." And concludes, "The results of these measurements demonstrated that the 12SL ECG Analysis System with Right Ventricular Analysis is as safe, as effective, and performs as well as the predicate devices."
This indicates that the acceptance criteria likely revolved around demonstrating performance comparable to the predicate devices, rather than predefined quantitative thresholds for diagnostic accuracy metrics (e.g., sensitivity, specificity) for specific cardiac conditions. The testing was focused on software verification and validation to ensure the algorithm functioned as intended and delivered results consistent with the predicate.
Given this, the following sections will reflect the information available in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Submission) | Reported Device Performance |
|---|---|
| Compliance with voluntary standards (as detailed in Section 9 of the submission - details not provided in excerpt) | "The 12SL ECG Analysis System with Right Ventricular Analysis complies with the voluntary standards as detailed in Section 9 of this submission." |
| Performance as safe, as effective, and as well as the predicate devices (K042177 MAC 5000 ECG Analysis System and K002209 12SL ECG Analysis Program) | "The results of these measurements demonstrated that the 12SL ECG Analysis System with Right Ventricular Analysis is as safe, as effective, and performs as well as the predicate devices." (Implies that testing confirmed comparable output and functionality, but specific quantitative metrics comparing to predicate are not detailed in this summary.) The submission states the device "employs the same functional technology as the predicate devices," implying that expected performance would be similar. |
| Successful completion of quality assurance measures (Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing) | "The following quality assurance measures were applied to the development of the system: Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing." (Implies all these measures were successfully completed, confirming software integrity and functionality per internal specifications.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Test Summary" mentions "Software Verification and Validation Testing" but does not elaborate on the datasets used for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth for any test set or their qualifications. The device's intended use states that its "initial automated interpretation" is "then confirmed, edited, or deleted by the physician," suggesting ongoing human expert involvement in clinical practice, but not necessarily in the validation study itself as described in this summary.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Based on the provided summary, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance does not appear to have been done or, at least, is not reported in this summary. The focus is on the stand-alone performance and substantial equivalence to existing predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance assessment was done, implicitly. The "Test Summary" and the general nature of a software algorithm submission for substantial equivalence imply that the algorithm's performance was evaluated independently. The device itself is described as a "software algorithm only" that provides "an initial automated interpretation." The validation described as "Software Verification and Validation Testing" would primarily assess the algorithm's output in a standalone capacity against some form of ground truth or expected output.
7. The Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used for any testing. Given the comparison to predicate devices, it's plausible that the ground truth for validation involved:
- Comparison with interpretations from the predicate 12SL ECG Analysis Program.
- Expert consensus from board-certified cardiologists or physicians specializing in ECG interpretation.
- Potentially, correlation with clinical outcomes or other diagnostic tests, though this is less likely to be the primary ground truth for a pure ECG interpretation algorithm's 510(k).
8. The Sample Size for the Training Set
The provided text does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for any training set was established. Given that the device "employs the same functional technology as the predicate devices," it's possible that the core algorithm (and thus its training, if any, or rule-based expert system development) relied on previously established and validated methodologies used for the predicate devices.
§ 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.