(32 days)
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.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance |
|---|---|---|
| Arrhythmia Analysis | Performance equivalent to HeartSine Samaritan® AED (K023854) algorithm. Efficacy of SCOPE biphasic waveform demonstrated in animal and human clinical trials. | Algorithm is identical to Samaritan® AED. Efficacy of SCOPE biphasic waveform demonstrated in animal and human clinical trials. |
| Energy Delivery | Deliver appropriate escalating energy sequence for defibrillation (100 J, 150 J, 200 J). Prompt user for shock. | Automatically charges to appropriate energy. Prompts user to press illuminated shock button. Delivers 100 J, 150 J, 200 J escalating energy sequence. |
| User Interface | Guide user through process with voice and visual prompts. | Incorporates voice prompts and visual graphic prompts. |
| Self-Tests | Automated self-tests with status indication. | Automated self tests with LED flashing status indicator. |
| Battery Life | Minimum 3 hours continuous operation OR 30 - 200 Joule shocks. | Minimum 3 hours of continuous operation OR 30 - 200 Joule shocks. |
| Data Recording | Record ECG and incident events with timestamps. | 1.5 hours of continuous ECG and timestamped incident events recorded. |
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.
§ 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.