(90 days)
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.
§ 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.