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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.

The 12SL ECG Analysis Program is a software only algorithm

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)

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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.

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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

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.

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