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The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• Unconscious .
• Not breathing .
• Without circulation .
  The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.
The Samaritan® AED incorporates the following features:

• . Backlight LCD display providing text prompts and ECG display
• Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
• Automated self tests with a separate status indicator display .
• . Controls for Power On/Off, Shock, Backlight, Contrast & manual override
• Integral event data recording incorporated in the removable battery .
  A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.

Here's an analysis of the provided text regarding the HeartSine Samaritan® AED, structured to answer your questions about acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the device complies with industry standards. The reported performance is framed in terms of this compliance.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "animal and human clinical trials" mentioned.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in any clinical trials.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The device is an AED, which is primarily an automated diagnostic and therapeutic device, rather than an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was conducted for the device's core function. The document states: "A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision." This implies that the algorithm performs its analysis and makes a decision independently. The overall device then guides the user to press a shock button if a shock is indicated, but the initial "shock or no-shock decision" is algorithmic.

7. The Type of Ground Truth Used

The document refers to "animal and human clinical trials" to demonstrate the efficacy of the biphasic waveform. For AEDs, the ground truth for efficacy would typically be:

• Clinical Outcomes Data: Such as successful defibrillation, return of spontaneous circulation (ROSC), and patient survival, observed in human trials.
• Physiological Response Data: In animal trials, this would involve observing the cessation of ventricular fibrillation and return to a perfusing rhythm.

For the shock/no-shock decision, the ground truth would typically be:

• Expert Consensus on ECG Interpretation: A panel of cardiologists or electrophysiologists independently reviewing ECGs and determining the presence or absence of a shockable rhythm (e.g., ventricular fibrillation, pulseless ventricular tachycardia). This is inferred, not explicitly stated in this document.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the "proprietary ECG analysis algorithm."

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

The document does not explicitly state how the ground truth for the training set was established. However, for an ECG analysis algorithm in an AED, it would typically involve:

• Annotated ECG Databases: Large databases of ECG recordings from patients in cardiac arrest, with each recording meticulously labeled by expert cardiologists or electrophysiologists as either a shockable rhythm (e.g., VF, pulseless VT) or a non-shockable rhythm (e.g., asystole, PEA, normal sinus rhythm).

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