Search Results

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.

Ask a specific question about this device

The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.

The ZOLL M Series NIBP Option non-invasively measures arterial blood pressure and pulse rate in resting adult, neonate and pediactric patients. By incorporating the SunTech Medical Instruments Advantage OEM BP™ Model 2 Module into the M Series Defibrillator/Monitor/Pacemaker devices, the option facilitates the ability to monitor and assess the physiological characteristics of the indicated patient populations.

The ZOLL M Series products (K972241) combine a defibrillator, ECG display, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 3-, 5- and 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) and Invasive Blood Pressure and Temperature (K011865), data printing and recording in a single instrument.

The provided text describes ZOLL Medical Corporation's 510(k) submission for the M Series NIBP Option (K032363), a non-invasive blood pressure measurement device. The submission asserts substantial equivalence to the predicate device, Protocol Systems, Inc. Propaq CS Vital Signs Monitor (K012451), based on performance information and compliance with various standards.

Here's the breakdown of the acceptance criteria and study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation. It only states that the 510(k) includes "documentation related to the performance of the incorporated NIBP module and compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards." This implies that the performance was assessed against these standards, but the details of the study (e.g., number of subjects, type of data) are not included.

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

The provided text does not mention experts used to establish ground truth or their qualifications. The evaluation appears to be based on compliance with established engineering and performance standards for NIBP devices, rather than a clinical ground truth established by experts.

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

The provided text does not describe any adjudication method. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which are not explicitly detailed here for the NIBP device performance.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. This study type is usually relevant for AI-powered diagnostic tools where human interpretation is involved. The ZOLL M Series NIBP Option is a measurement device, and its performance evaluation is framed around compliance with technical standards.

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

The provided text suggests that the performance evaluation was primarily focused on the device's technical specifications and its compliance with relevant standards (ANSI/AAMI SP-10-1992, EN 1060 series, IEC 60601 series, AAMI DF2, AAMI DF39). This implies a standalone assessment of the device's accuracy and safety against pre-defined benchmarks, without explicit mention of human operators in the loop influencing the measurement performance reported for regulatory submission. The device is used by humans, but the performance testing described focuses on its intrinsic measurement capabilities.

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

The "ground truth" for the device's performance is implicit in the standards it aims to comply with. For blood pressure measurement devices, this typically refers to a reference method (e.g., direct arterial measurement or a highly accurate auscultatory method) against which the automated device's readings are compared. The text explicitly lists various ANSI/AAMI, CEN, and IEC standards for automated noninvasive blood pressure, defibrillator, and monitor systems. These standards define the expected accuracy and performance limits, which serve as the "ground truth" or reference for the device's validation.

8. The sample size for the training set

The provided text does not mention a training set or its size. This is typical for medical devices that are not "learning" algorithms in the modern sense (e.g., AI/ML). The NIBP module is an established technology, and its performance is validated against engineering and clinical standards rather than being "trained" on data.

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

Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided text.

Ask a specific question about this device