(128 days)
The HeartStart MRx monitor/defibrillator with Q-CPR™ option is for use for the termination of ventricular tachycardia and ventricular fibrillation.
The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation Therapy: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronized defibrillation is indicated for termination of atrial fibrillation.
Non-Invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-Invasive Blood Pressure Monitoring: The NIBP option is intended for noninvasive measurement of a patient's arterial blood pressure.
Endtidal CO2 Monitoring: The EtCO2 option is intended for noninvasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG: The 12-Lead ECG option is intended to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time).
The Q-CPR option is contraindicated as follows:
- The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg).
- The Q-CPR option is not for use when CPR is contraindicated.
The HeartStart MRx monitor/defibrillator with Q-CPR™ option is a lightweight, portable monitor/defibrillator, one of the United States models, with an option to provide visual and audible feedback to the rescuer on the quality of CPR.
In manual mode, the HeartStart MRx monitor/defibrillator with Q-CPR™ option is a fullfeatured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation, perform synchronized cardioversion and provide non-invasive external pacing.
In AED mode, the HeartStart MRx monitor/defibrillator with Q-CPR™ option, allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient's rhythm and advises the user to provide a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display.
In both modes of operation, the HeartStart MRx monitor/defibrillator with Q-CPR™ option utilizes impedance compensating biphasic truncated exponential therapy waveform.
The HeartStart MRx monitor/defibrillator with Q-CPR™ option can also be used for ECG monitoring of a patient using either 3 or 5 lead cables.
Additionally, the HeartStart MRx monitor/defibrillator with Q-CPR™ option is offered with the following optional functionality: Non-Invasive External Pacing, 12-Lead ECG, Non-Invasive Blood Pressure, Endtidal CO2, Pulse Oximetry.
The document describes the HeartStart MRx monitor/defibrillator with Q-CPR™ option as a device that provides CPR feedback. However, it does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria, particularly for the Q-CPR™ functionality in a quantitative manner as requested. Instead, it relies on substantial equivalence to predicate devices and general bench testing.
Based on the provided text, here is a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria for the Q-CPR™ option's performance itself (e.g., accuracy of depth, rate detection). Instead, it states the Q-CPR™ option "provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume, and flow rate (inflation time)."
The "reported device performance" is essentially that the device "meets its specification" through bench testing. No specific quantitative performance metrics for the Q-CPR™ feedback accuracy are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification." However, it does not specify:
- The sample size used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts or how ground truth was established for the performance evaluation of the Q-CPR™ features. The primary method described is bench testing against specifications.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned in the document, as it relies on bench testing rather than expert-reviewed cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The document focuses on the device's equivalence to existing devices and its technical specifications, not on human reader performance improvement with or without AI assistance.
6. Standalone Performance Study:
A standalone performance evaluation of the algorithm specifically for the Q-CPR™ functionality is not detailed in terms of quantitative metrics (e.g., accuracy of detecting correct compression depth/rate). The document broadly states "Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specification." This implies some form of standalone testing was done against internal specifications, but no data from such a study is provided.
7. Type of Ground Truth Used:
The type of "ground truth" for the Q-CPR™ function, if any formal ground truth was established for its performance accuracy, is not explicitly stated. Given the context of "bench testing," the "ground truth" likely refers to predefined engineering specifications and simulated inputs rather than expert consensus, pathology, or outcomes data from human subjects.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. This type of device approval summary often focuses on the final product and its validation rather than details of potential machine learning model training, if any were involved (which is unlikely given the 2005 date and the nature of the device).
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned, information on how its ground truth was established is also not provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The primary "study" described that proves the device meets (or is equivalent to) acceptance criteria is bench testing and biocompatibility testing.
- Bench Testing: This included hardware and software testing. The goal was to "demonstrate that the performance of the device meets its specification." This testing covered the overall device, including the Q-CPR™ functions, by ensuring its output aligned with internal design and performance specifications.
- Biocompatibility Testing: This was conducted "on the patient-contact materials of the Q-CPR™ sensor" to ensure safety.
The conclusion from these tests was that the HeartStart MRx monitor/defibrillator with Q-CPR™ option "does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices" and is "substantially equivalent" to them. This indicates a reliance on regulatory equivalence rather than a detailed, standalone clinical performance study specifically for the Q-CPR™ feedback accuracy.
§ 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.