(169 days)
The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement (proposed), End Tidal CO2 (proposed), CPR performance and data printing and recording for resting patients in critical care and in-hospital 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.
Defibrillator Function:
Manual Operation: Use of the R Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Semiautomatic Operation (AED): The R Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically approved patient care protocol. Use of the R Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.
ECG Monitoring: The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.
External Pacemaker (Pacer Version Only):
Pacemaker: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia.
SpO2 Monitoring: The R Series pulse oximeter, with the Masimo® SET® technology and the LNCS® series of oximeter sensors, is indicated for the continuous, monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients in a hospital or prehospital environment.
NIBP Monitoring: The ZOLL R Series NIBP option is indicated for the non-invasive measurement of arterial blood pressure for resting patients in critical care and in-hospital transport.
EtCO2 Monitoring: The ZOLL R Series EtCO2 option with Respironics Novametrix technology is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, in-hospital transport, or anesthesia.
The ZOLL R Series® External Defibrillator is intended for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including ECG Monitoring, Pulse Oximetry, Non-Invasive Blood Pressure measurement (proposed), End Tidal CO2 (proposed), CPR performance and data printing and recording for resting patients in critical care and in-hospital 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 provided text describes ZOLL R Series® NIBP and EtCO2 Options, a multi-parameter monitor, but does NOT contain specific acceptance criteria, detailed performance study results, or information about AI/ML algorithms.
The document states:
"Extensive performance testing ensures that the ZOLL R Series with NIBP and EtCO2 Options performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."
This is a general statement about testing without providing quantifiable acceptance criteria or detailed results. The submission focuses on demonstrating substantial equivalence to a predicate device (ZOLL E Series NIBP and EtCO2 Options).
Therefore, I cannot fulfill the detailed request for acceptance criteria, device performance, sample sizes, expert qualifications, or details specific to AI/ML comparative effectiveness or standalone studies.
Based on the provided text, I can only provide the following limited information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. It generally states that "Extensive performance testing ensures that the ZOLL R Series with NIBP and EtCO2 Options performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document, as the device is a medical monitor, not an AI/ML diagnostic tool requiring expert ground truth for its performance validation in the typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document does not mention an AI/ML component or an MRMC study. This device is a monitor, not a diagnostic AI/ML tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe an AI/ML algorithm or a standalone performance study for such an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document focuses on the measurement capabilities (NIBP, EtCO2) and functionality of a monitor, not on an algorithm requiring ground truth in the context of diagnostic interpretation. Device performance would typically be validated against reference standards for physiological measurements. No details on this are provided beyond the general statement of "extensive performance testing."
8. The sample size for the training set
This information is not provided as the document does not describe an AI/ML algorithm that would undergo a training phase.
9. How the ground truth for the training set was established
This information is not applicable as the document does not describe an AI/ML algorithm that would require a training set with established ground truth.
Summary of Device and Testing Approach from the Document:
The ZOLL R Series® NIBP and EtCO2 Options is a multi-parameter monitor. The regulatory submission emphasizes substantial equivalence to a predicate device (ZOLL E Series NIBP and EtCO2 Options) rather than comprehensive de novo performance studies with detailed statistical results. The testing described is "extensive performance testing" and "safety testing" to ensure it meets functional requirements, performance specifications, and complies with industry and safety standards, similar to the predicate device.
§ 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.