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The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

• . Unconscious
• . Not breathing
• Without circulation

The samaritan® PAD 350P 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® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

The HeartSine samaritan® PAD (Public Access Defibrillator) 350P (also called the SAM 350P) is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The samaritan® PAD 350P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. The samaritan® PAD 350P also incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation guidelines.

A proprietary ECG analysis algorithm automatically determines whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. If a shock is required, the samaritan will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient.

An escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines.

After initial analysis and shock delivery (if appropriate), the PAD 350P will advise that CPR (cardiopulmonary resuscitation) may be commenced via a number of voice prompts such as "It is safe to touch the patient" and "Begin CPR" in addition to emitting an audible metronome.

The defibrillator records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software.

The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the samaritan® PAD 350P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a pediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft.

The samaritan® PAD 350P incorporates the following features:

• . Controls for Power ON/OFF and Shock
• Automated charging at escalating energies of 150J, 150J, 200J .
• Automated self-tests and LED status indicator .
• Combined, disposable battery and electrodes (Pad-Pak™) .
• Electrode placement guidance voice prompts and LED/icon indicators .
• CPR voice prompts and metronome .
• Pediatric function for victims between the ages of 1 and 8 years at non-. escalating energy of 50 J
• . Integral event data recording

This document describes the HeartSine samaritan® PAD 350P, an Automated External Defibrillator (AED). The acceptance criteria for the device's arrhythmia analysis algorithm are not explicitly stated in numerical terms within the provided text. However, the document does mention the use of "Standardised AHA, MIT and CU databases" to extensively validate the algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions the use of "Standardised AHA, MIT and CU databases" for algorithm validation, but the number of cases or recordings within these databases used for testing is not provided.
• Data Provenance: The data comes from "Standardised AHA, MIT and CU databases." These are recognized, publicly available databases of ECG signals often used for arrhythmia analysis research and defibrillator algorithm testing. The document does not specify the country of origin for these specific databases but they are generally international in scope. It is not stated whether the data is retrospective or prospective, but data from such established databases is typically retrospective for validation purposes.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For "Standardised AHA, MIT and CU databases," the ground truth (e.g., shockable vs. non-shockable rhythms) would have been established by experts, likely cardiologists or electrophysiologists, during the creation of these databases. However, the specific details for this device's validation are not provided.

4. Adjudication Method for the Test Set

• Not specified. Given the use of "Standardised" databases, the ground truth would have been predetermined within those databases through an adjudication process during their initial creation, but the specific method (e.g., 2+1, 3+1) is not detailed for this device's validation.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The document focuses on the automated external defibrillator's algorithm and overall device performance, not on aiding human interpretation of ECGs. The device itself is an "automated" external defibrillator, where the algorithm makes the primary decision regarding shock delivery.

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

• Yes, a standalone algorithm performance evaluation was done. The statement "Standardised AHA, MIT and CU databases were used to extensively validate the HeartSine samaritari® PAD 350P algorithm" directly indicates standalone validation of the algorithm's performance against these established datasets. The device automatically determines shockable rhythm, implying standalone capability.

7. The Type of Ground Truth Used

• Expert Consensus / Reference Databases: The ground truth for the algorithm validation was based on the classifications (shockable/non-shockable rhythms) established within the "Standardised AHA, MIT and CU databases." These databases are curated with expert-adjudicated diagnoses.

8. The Sample Size for the Training Set

• Not explicitly stated within the provided text. The document only mentions the use of "Standardised AHA, MIT and CU databases" for validation of the algorithm. It does not provide information about a distinct training set or its size. It's possible the algorithm was developed using other datasets or iterative refinement, but this is not detailed.

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

• Not explicitly stated within the provided text because the training set itself is not detailed. If the "Standardised AHA, MIT and CU databases" were also used for training (which is less common for validation datasets after development), then the ground truth would have been established by expert consensus within those databases.

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

• Unconscious .
• Not breathing
• Without circulation .

The Samaritan® PAD 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 Samantan® PAD is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® PAD is a small, lightweight portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® PAD incorporates a simple user interface of voice prompts and visual graphic prompts to guide the user. A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model Samaritan® AED. If a shock is required, the Samaritan® PAD will automatically charge to the appropriate energy level and prompt 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® PAD will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® PAD uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's heart rhythm and, if required, deliver the defibrillation pulse to the patient.

The Samaritan® PAD incorporates the following features:

• An LED graphic display providing visual graphic prompting to the . user
• Automated self tests with an LED flashing status indicator .
• Integral event data recording

The Samaritan® PAD uses a disposable, non-rechargeable lithium manganese dioxide battery to operate the Samaritan® PAD for a minimum of 3 hours of continuous operation or provide a minimum of 30 - 200 Joule shocks. The disposable battery is housed in a plastic tray with the disposable defibrillation pads. By housing the battery in the same rigid plastic tray as the electrodes, this will greatly assist the end user in keeping the device in a state of readiness. This will also help eliminate the chance that the end user would respond to an incident with a good battery but expired electrodes, as could happen with many other AEDs currently.

Event details are recorded internally in the Samaritan® PAD for later retrieval on a computer. 1.5 hours of continuous ECG as well as incident events time stamped are recorded. Event and incident data can be viewed, printed, annotated and forwarded using the HeartSine SAVER software program. The Samaritan® PAD incorporates a USB communication port that allows for downloading event details to the SAVER software program. This USB port also allows for changing language settings for the Samaritan® PAD voice prompts and allows for customizing the factory settings.

Samaritan® PAD also incorporates a training module which converts the Samaritan® PAD into a training device. The training module will automatically disable the Samaritan® PAD energy delivery capability. This training module will allow the user to select training scripts, which simulate different rescue and demonstration scenarios.

The provided text outlines the acceptance criteria and study information for the HeartSine Samaritan® PAD, an Automated External Defibrillator (AED).

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Samaritan® PAD's analysis algorithm is identical to the Samaritan® AED (K023854) which is already in commercial distribution. Therefore, the acceptance criteria and performance are implicitly aligned with the previously cleared device. The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials, implying that the device meets the established safety and efficacy standards for defibrillation. While specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds for arrhythmia detection) are not explicitly detailed in the provided text, the core performance is tied to its predicate device.

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

The document states, "The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials." However, it does not specify the sample size for these clinical trials used to demonstrate the algorithm's efficacy, nor does it explicitly state the country of origin of the data or whether the data was retrospective or prospective. It implies that these studies were conducted for the original Samaritan® AED (K023854) and are being referenced for the PAD model's substantial equivalence.

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

This information is not provided in the given text. While it mentions "human clinical trials," it does not detail the process of establishing ground truth for the test sets with experts.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned in the provided text. The device is an Automated External Defibrillator (AED), which is primarily an automated device designed to be used by trained personnel, not a diagnostic aid for human readers in the traditional sense of an MRMC study.

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

Yes, a standalone performance assessment of the algorithm was implicitly done. The document states, "A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854." It also mentions "The efficacy of the HeartSine SCOPE biphasic waveform in this device has been demonstrated in animal and human clinical trials." This suggests that the algorithm's ability to accurately detect arrhythmias and make shock/no-shock decisions independent of continuous human interpretation was evaluated in the context of the previous clearances.

7. The Type of Ground Truth Used

Based on the nature of AEDs, the ground truth for their algorithms is typically established through a combination of:

• Expert Consensus (Cardiologists/Electrophysiologists): For highly ambiguous ECG rhythms, expert cardiologists would classify rhythms as shockable or non-shockable.
• Outcomes Data: The ultimate ground truth for an AED is its ability to successfully defibrillate a patient in cardiac arrest, leading to a return of spontaneous circulation. This can be derived from clinical trial outcomes.
• Pathology/Physiology during animal/human clinical trials: Evaluation of the waveform's impact on cardiac tissue and rhythm during trials would contribute to establishing efficacy.

The provided text generally refers to "animal and human clinical trials" for waveform efficacy, which would typically involve these types of ground truth.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set of the algorithm. Since the algorithm is "identical" to a previously cleared device, the training would have occurred prior to that clearance (K023854).

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

The document does not provide specific details on how the ground truth for the training set was established. However, for AED algorithms, it typically involves:

• Large databases of annotated ECGs: These databases are usually curated by expert cardiologists who classify rhythms (e.g., ventricular fibrillation, asystole, normal sinus rhythm, other non-shockable rhythms).
• Data from real-world cardiac arrest events: Retrospective or prospective collection of ECG data from actual cardiac arrest victims, where the outcome (resuscitation, no resuscitation, presence of shockable rhythm) is known and often confirmed by medical professionals.

The general statement about "animal and human clinical trials" for the "efficacy of the HeartSine SCOPE biphasic waveform" implies a robust process of data collection and ground truth establishment for both development and testing of the algorithm.

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