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The M Series with Real CPR Help is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage the compression depth of greater than 1.5 to 2 inches for adult patients. The CPR monitoring function is not intended for use on paients under 8 years of age

The ZOLL M Series with Real CPR Help™ provides 'real-time' user CPR assistance when used in conjunction with ZOLL CPR-D-padz™ and CPR Stat-padz™ Multi-function Electrodes. CPR feedback is provided via ZOLL's unique sensor assembly that relays user compression data to the ZOLL. M Series. The ZOLL M Series with Real CPR Help™ provides a metronome to encourage rescuers to perform CPR at the AHA/ECR recommended rate of 100 compressions per minute (CPM). The ZOLL M Series additionally provides chest compression performance feedback to the user through displayed symbols, text messages and voice prompts.

The ZOLL M Series Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport.

The provided text describes ZOLL M Series with Real CPR Help™ and its functionalities but does not contain detailed information about acceptance criteria and a specific study proving the device meets those criteria, as typically presented in a scientific publication or a dedicated performance evaluation section.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with specific metrics, acceptance criteria, and ground truth establishment as would be found in a clinical trial report.

However, based on the intended use and description of the device, we can infer some implicit performance goals and how the provided text generally addresses them.

Inferred Acceptance Criteria and Reported Device Performance

Missing Information (Not provided in the document for a typical performance study):

The document does not detail a specific "study" in the traditional sense of a clinical trial or a statistically powered performance evaluation with primary and secondary endpoints, sample sizes, and ground truth methodologies that are usually associated with AI/ML device performance descriptions. Here's why and what's missing:

1. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "extensive performance testing" and "functional testing" but does not specify sample sizes (e.g., number of compressions evaluated, number of subjects, or data points) or the origin of any data used for these tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The device provides feedback based on AHA/ERC guidelines, which are expert-derived, but the document doesn't describe an independent expert ground truth establishment for testing the Real CPR Help's accuracy in delivering those prompts. The "ground truth" here is implied to be the established AHA/ERC guidelines themselves for target rate and depth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the provided text, as no expert adjudication for ground truth is described.
4. 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: This is not provided and is not applicable in the context of this device. The device assists rescuers (not "readers") in performing CPR. The document states its intended use is to "encourage rescuers to perform chest compressions" at recommended rates and depths. It doesn't present an effectiveness study to quantify how much rescuers improve with the device vs. without it.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Real CPR Help" feature is the algorithm, and its performance is inherently tied to providing feedback to a human-in-the-loop. The textual performance descriptions ("provides metronome," "provides feedback," "acquires signals") relate to its standalone function of processing data and generating prompts. However, a formal standalone performance study with specific metrics (e.g., accuracy of rate detection, accuracy of depth detection against a gold standard sensor) is not detailed.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the feedback mechanism is the AHA/ERC recommended guidelines for CPR rate (100 CPM) and depth (1.5-2 inches). The accuracy of the device would then be measured by how well its internal sensors and algorithms detect and report these parameters, and how effectively its prompts align with these guidelines. The document does not describe the specific methodology for establishing measurement ground truth (e.g., using a high-precision force/motion sensor as a gold standard to validate the device's sensor readings).
7. The sample size for the training set: This information is not provided. Given the nature of medical device 510(k) submissions for non-AI/ML systems, details about "training sets" are often not explicitly mentioned. The device's functionality likely relies on established signal processing and measurement techniques rather than a "trained" machine learning model in the contemporary sense.
8. How the ground truth for the training set was established: This information is not provided. Again, for a traditional medical device (before the widespread use of deep learning), a "training set" doesn't typically exist in the same way as an AI/ML model. The device is engineered to meet specific physical and physiological parameters based on established guidelines.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed scientific paper on device performance. It attests to the device's functional integrity and adherence to intended physiological targets (AHA/ERC guidelines) through general claims of "extensive performance testing" and "functional testing" but lacks the granular data and methodological details requested for a comprehensive performance study description.

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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 ZOLL M Series EtCO2 LoFlo™ Option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in intubated and non-intubated adult, pediatric and infant patients requiring ventilator support, procedural sedation, transport, anesthesia and other clinical vonditions where EtCO, monitoring is deemed appropriate by the attending care giver. The M Series EtCO2 LoFlo™ Option uses nasal and nasal/oral sampling cannulas and sidestream on-airway adapter kits.

The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.

The ZOLL M Series EtCO2 Option with LoFlo™ Sidestream CO2 is a sidestream sampling system using a 50ml/minute low sampling rate to measure the EtCO2 of non-intubated and intubated infant, pediatric and adult patients using specially designed sampling cannulas and on-airway adapter kits.

The LoFlo™ Sidestream CO2 module includes Respironics Novametrix CAPNOII infrared absorption technology. The module is contained in a small plastic enclosure with a short cable that connects to the same M Series connector used by the existing EtCO2 Capnostat 3 sensor. The module uses the same hardware communications interface to the M Series as the existing Capnostat 3 sensor and a slightly expanded software communications protocol.

The provided text describes a 510(k) summary for the ZOLL M Series EtCO2 LoFlo™ Option. It states that "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications" and concludes that "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."

However, the document does not provide specific details on the acceptance criteria (e.g., threshold values for accuracy, precision, etc.) or the detailed results of the performance testing. It also lacks information on the methodology of such a study, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

Therefore,Based on the provided document (K042417), I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them because the document does not contain this specific information.

The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent performance study with specific acceptance criteria and results. The document states:

• "Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications."
• "Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."

This indicates that internal testing was conducted to ensure the device met its own specifications and to support the substantial equivalence claim. However, the details of these tests, including specific acceptance criteria, reported performance values, sample sizes, and ground truth methodologies, are not included in this 510(k) summary.

Without this specific information in the provided text, I cannot complete the requested table or answer the detailed questions about the study design.

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The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in patients meeting the following clinical criteria:

• the patient should be unconscious and unresponsive
• the patient should be apneic (not breathing)
• the patient should be pulseless .

Not Found

The provided document is an FDA 510(k) clearance letter for the ZOLL M Series Bi-Phasic Option, a low energy DC defibrillator.

This document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

However, the third page (Image /page/2/Picture/1) of the document mentions:

"The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices."

This sentence indicates that clinical trials were performed to demonstrate the effectiveness of the device's waveform. However, the letter does not provide specific details regarding:

• Acceptance Criteria Table: No table of acceptance criteria or reported device performance is present.
• Sample Size or Data Provenance for Test Set: The document states "multi-center, prospective, randomized... clinical trials" but does not provide specific sample sizes or countries of origin.
• Number/Qualifications of Experts for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: The letter states the device was "proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices." This implies a comparison, but it doesn't specify if it was an MRMC study with human readers or solely focused on device performance. No effect size for human reader improvement is provided.
• Standalone Performance: The "proven to defibrillate and cardiovert" statement implies standalone performance was assessed.
• Type of Ground Truth: Implied to be clinical outcomes (defibrillation/cardioversion success), but not explicitly detailed.
• Training Set Sample Size: Not mentioned, as this is a clinical trial, not an AI model training.
• Ground Truth for Training Set: Not applicable in the context of device performance trials as typically described in this letter.

In summary, while the document states that clinical trials were performed and were successful in demonstrating the device's capability, it does not provide the level of detail requested regarding acceptance criteria, study design parameters, or ground truth establishment that would be found in a comprehensive study report for an AI/CADe device.

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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.

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IBP: The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for use with resting patients in critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only. TEMPERATURE: The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.

ZOLL M Series IBP and Temperature Option

I am sorry, but the provided text from the FDA 510(k) summary for the ZOLL M Series IBP and Temperature Options does not contain the acceptance criteria or a study detailing the device's performance against those criteria.

The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It outlines the indications for use and contraindications but does not include any technical specifications, performance metrics, or study results related to sensitivity, specificity, accuracy, or other performance characteristics.

Therefore, I cannot provide the requested information in the table format or answer the questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information would typically be found in the more detailed 510(k) submission itself, which is not provided here.

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The ZOLL M Series EtCO2 option with Novametrix technology and Capnostal® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia.

ZOLL M Series EtCO2 Option

This document is a 510(k) clearance letter from the FDA for the ZOLL M Series EtCO2 Option. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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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.

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