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The 12-Lead ECG Analysis is useful in the diagnosis and treatment of patient with acute myocardial infarction (AMI). The analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the analysis results can be of assistance to the clinician in preparing for the patient has arrived in the hospital emergency department.

The ZOLL M Series products (K972241) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) Invasive Blood Pressure and Temperature (K011865) and data printing and recording in a single instrument.

The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. The 12-Lead ECG Analysis is indicated for the recording and analysis of 12 Lead ECG signals acquired from adult and pediatric patients in the supine, resting position. The Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) are decision aids for qualified clinicians who may currently wish to calculate ACI-TIPI and TPI in adult patients.

The provided text describes ZOLL M Series 12SL™ Analysis Option, an enhancement to existing ZOLL M Series products. However, it does not include detailed acceptance criteria or a specific study proving the device meets said criteria.

The submission focuses on establishing substantial equivalence to a predicate device (ZOLL M Series 12SL™ Analysis Option, K991556, cleared 2/28/2000) rather than presenting a de novo performance study against explicit acceptance criteria.

Therefore, I cannot populate the table with acceptance criteria or describe a study that explicitly proves the device meets those criteria from the provided text.

Here's what can be inferred or stated as "not found" based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device.
• Reported Device Performance: Not explicitly reported as quantifiable metrics against acceptance criteria. The document states "Extensive performance testing ensures that the ZOLL M Series 12SL™ Analysis Option performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." This is a general statement, not specific performance data.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as a specific performance study against a ground truth is not detailed. The submission relies on substantial equivalence.

4. Adjudication method for the test set

• Not applicable, as a specific performance study against a ground truth is not detailed.

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 MRMC study is mentioned. The device is an analysis option using the GE/Marquette 12SL™ Algorithm, which is an interpretive tool, not an AI assistance for human readers in the context of comparative effectiveness.

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

• The document implies standalone performance of the algorithm for "interpretation and documentation of other transient cardiac arrhythmias" and "diagnosis of patients with acute myocardial infarction (AMI)" when it states that the "12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis... and is useful in the interpretation and documentation." However, no specific study details are provided.

7. The type of ground truth used

• Not explicitly stated because a specific performance study against ground truth is not detailed. The intended use "useful in the diagnosis of... AMI" and "interpretation and documentation of other transient cardiac arrhythmias" suggests a comparison to clinical diagnosis, but the methodology is not provided.

8. The sample size for the training set

• Not applicable. The device utilizes the GE/Marquette 12SL™ Algorithm, which is a pre-existing algorithm. The document doesn't discuss the training of this algorithm.

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

• Not applicable. The document doesn't discuss the ground truth for the training of the GE/Marquette 12SL™ Algorithm.

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The 12-lead ECG Analysis is useful in the diagnosis and treatment of patients with acute myocardial infarction (AMI). 12-lead ECG Analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the 12-lead analysis results can be of assistance in diagnosis and treatment decisions once the patient has arrived in the hospital emergency department.

Not Found

The provided document is a 510(k) clearance letter for the ZOLL M Series 12SL™ Analysis Option. This document confirms the device's substantial equivalence to a predicate device and outlines its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.

Specifically, the letter does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
• Details on how ground truth was established for either test or training sets.

To provide a complete answer, I would need access to the actual 510(k) submission document (or a summary thereof) which would typically contain the study design, methodologies, and results used to demonstrate substantial equivalence.

Therefore, I cannot fully answer your request based solely on the provided text.

Ask a specific question about this device