(21 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
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.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.