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The ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment.

The ZOLL R Series® External Defibrillator is intended for the defibrillation. Noninyasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement, End Tidal CO2, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The design facilitates table top use while still providing a light weight and easy to carry device for transport.

The ZOLL R Series software, which currently supports the 2005 American Heart Association's (AHA) Guidelines for CPR, has been revised to optionally support the new revised 2010 AHA's Guidelines for CPR. The specific changes include:

• Adding, in the form of a configuration option, a minimum CPR target compression depth . of at least 2.0 inches in addition to the 2005 AHA guidelines depth as described in Chapter 6 of the R Series ALS Operator's guide included in Attachment 11-1 and Chapter 7 of of the R Series Plus/ R Series BLS Operator's Guide included in Attachment 11-2. Both depth configurations are necessary since the training to and implementation of the new guidelines occur over a number of years.
• . Adding an optional configuration option to display an informational message to remind the users to release their hands from the chest between compressions in order to allow the chest to recoil. When the R Series is configured to display this new message, the message FULLY RELEASE will be displayed every 45 seconds, for 5 seconds, as long as CPR compressions are detected.

The provided text describes a 510(k) Summary for the ZOLL R Series® with a 2010 AHA Guidelines Software Update. This document details the device's intended use, technological characteristics, and a general statement about performance testing, but it does not contain specific acceptance criteria, detailed study designs, or reported performance metrics for the updated software features related to the 2010 AHA guidelines. The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Extensive performance testing ensures that the ZOLL R Series Defibrillator meets all of its functional requirements and performance specifications." And "Performance testing of the ZOLL R Series Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."

However, no specific acceptance criteria (e.g., minimum accuracy percentages, sensitivity/specificity thresholds) or the results of this "extensive performance testing" are provided for the software update. The original device (without the 2010 AHA update) would have had such criteria, but they are not detailed for the changes introduced by this specific submission. The new software specifically changes the CPR compression depth prompt from 1.5"-2.0" to "at least 2.0"" and adds a "FULLY RELEASE" message. No performance metrics are given for these specific new features.

2. Sample Size Used for the Test Set and the Data Provenance:

Not specified in the provided text for the software update.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not specified in the provided text for the software update.

4. Adjudication Method for the Test Set:

Not specified in the provided text for the software update.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not mentioned in the provided text. The submission is for a software update that primarily changes CPR feedback prompts, not for an AI-assisted diagnostic tool that would typically undergo MRMC studies.

6. Standalone (Algorithm Only) Performance Study:

Not directly addressed as a "standalone" study in the context of an AI algorithm. The software update is integrated into a medical device. The document implies that the device's overall performance was tested, but not specifically the algorithm driving the new CPR feedback in isolation with detailed metrics.

7. Type of Ground Truth Used:

Not specified for the software update. For the original "ECG Rhythm Analysis Algorithm Accuracy" mentioned on page A-29 (not included in the provided text but referenced), the ground truth for rhythm analysis would typically be expert cardiologist review, but this is not confirmed for the new software.

8. Sample Size for the Training Set:

Not applicable. The software update primarily adjusts existing CPR feedback logic based on updated AHA guidelines. There is no mention of a machine learning model being trained with data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, there's no indication of a training set for a machine learning model. The basis for the software changes is the 2010 American Heart Association Guidelines for CPR.

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