12SL ECG ANALYSIS PROGRAM

• K Number: K141963
• Device Name: 12SL ECG ANALYSIS PROGRAM
• Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Date Cleared: 2015-02-05 ( 202 days)
• Product Code: MHX
• Regulation Number: 870.1025
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be 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.

The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.

Device Description

The 12SL ECG Analysis Program is a software only algorithm

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the GE 12SL ECG Analysis Program, based on the provided document:

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria for performance. Instead, it states that "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence." This means the device's equivalence to a legally marketed predicate device (12SL ECG Analysis Program K#092369) was established through non-clinical tests and the assertion that it employs the "same functional scientific technology."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, or details of a study proving the device meets those criteria, as such information is explicitly stated as not required and thus not present in the provided text.

However, I can extract information related to the non-clinical tests and general compliance:

1. A table of acceptance criteria and the reported device performance

• Not applicable. The document explicitly states: "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence." Therefore, no specific performance acceptance criteria or reported device performance from a clinical study are detailed. Non-clinical tests focused on compliance with standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. No clinical test set was used or described.

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 applicable. No clinical test set or ground truth established by experts is mentioned for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication method is mentioned.

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

• No, an MRMC comparative effectiveness study was not done. The document states no clinical studies were required.

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

• Not applicable. No standalone performance study is explicitly described. The device "assists the physician" and the interpretation "may then be confirmed, edited, or deleted by the physician," indicating it's intended for human-in-the-loop use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No ground truth for algorithm performance is described as no clinical studies were conducted for this premarket submission.

8. The sample size for the training set

• Not applicable. The document does not provide details on the training set for the algorithm, as it primarily focuses on demonstrating substantial equivalence to a predicate device via non-clinical testing and shared technology.

9. How the ground truth for the training set was established

• Not applicable. The document does not provide details on how the ground truth for any training set might have been established.

Summary of Non-Clinical Tests and Compliance:

The device's substantial equivalence was supported by non-clinical tests demonstrating compliance with:

• IEC 60601-2-25:2011 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs - Edition 2.0
• Relevant Guidances and/or Special Controls detailed in Section 9 of the premarket submission (details not provided in the excerpt).

Quality Assurance Measures Applied to Development:

• Requirements Reviews
• Risk Analysis
• Software Verification and Validation
• Performance testing (presumably non-clinical, related to compliance with standards)

Regulation Number and Section

§ 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.