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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 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 Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices. The M Series Biphasic Option incorporates some user selectable energy settings, which are lower than those used during those dinical trials.

There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatric applications. Or

The M Secies Biohasionalisation for direct defibrillation of the heart during open chest surgical/ (procedures.

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

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

Do not use the unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Warning Cardiopulmonary Resuscitation and AED, 3-5, 1998).

Not Found

This looks like a medical device approval document, specifically a 510(k) premarket notification for the ZOLL M Series Bi-Phasic Option. Unfortunately, this type of document typically does not contain the detailed study information required to answer your prompt.

Here's why and what kind of information it does provide:

• 510(k) Premarket Notifications: These submissions primarily demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily extensive clinical efficacy trials. While some clinical data might be included, it's usually summarized or referenced, not presented with the granular detail you're asking for about acceptance criteria, sample sizes, expert qualifications, etc.
• Focus of this Document: This specific document is the FDA's letter of clearance for the 510(k) submission, along with the "Indications for Use." It confirms the device can be marketed. It refers to past clinical trials (paragraph 4 on page 3) but doesn't describe them in detail.

Based on the provided text, I can extract the following limited information regarding studies:

1. A table of acceptance criteria and the reported device performance:

• Does not exist in this document. The document states: "The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices." This is a summary statement of success, not a table of specific criteria and performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified.
• Data Provenance: "multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials." No country of origin is mentioned.

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):

• Not specified. Clinical trials would have involved physicians, but their roles in "establishing ground truth" are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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:

• Not applicable / Not specified. This device is a defibrillator, not an AI-powered diagnostic tool requiring human readability or interpretation. The document mentions "proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices," which implies a comparative effectiveness study against monophasic devices. However, it's not a "human reader" study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not specified. Again, this is a physical medical device (defibrillator), not an algorithm or AI. It functions to deliver an electrical shock. The "AED or advisory function" is mentioned, which implies some automated analysis to confirm VF, but details of its standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For a defibrillator, ground truth would typically be patient outcomes related to successful termination of VT/VF and AF. The sentence "proven to defibrillate and cardiovert adult patients" directly implies this.

8. The sample size for the training set:

• Not specified. The document refers to "clinical trials" which are likely the testing set (or main study data), but no separate training set is mentioned or implied, especially since this is not an AI/ML device in the modern sense of requiring extensive training data.

9. How the ground truth for the training set was established:

• Not specified.

In summary, the provided document is a regulatory clearance letter and provides very high-level information about the clinical studies conducted. It does not contain the granular detail about study methodology, acceptance criteria tables, sample sizes, expert qualifications, or adjudication methods that your prompt requests. To get that level of detail, one would typically need to review the full 510(k) submission, the associated clinical study reports, or published peer-reviewed literature related to the device.

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