(206 days)
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
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Arrhythmia Analysis Algorithm Validation | The algorithm should accurately determine whether a victim has a shockable or non-shockable rhythm and advise a shock when appropriate, in accordance with current AHA resuscitation guidelines. (Implied by device description and predicate device equivalence) | "Standardised AHA, MIT and CU databases were used to extensively validate the HeartSine samaritan® PAD 350P algorithm." This implies satisfactory performance against established benchmarks without providing specific metrics like sensitivity or specificity. |
| Energy Levels | Delivery of appropriate energy levels for defibrillation. (Implied by device description and AHA guidelines) | "A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines." For pediatric use: "non-escalating energy of 50 J." |
| CPR Coaching | Provides accurate guidance for chest compressions. (Implied by new feature compared to predicate) | "Complies with 2010 AHA guidelines, including a CPR metronome that signals rate of chest compressions during the 2-minute CPR period(s) at 110 compressions-per-minute" and "CPR voice prompts and metronome." |
| Safety and Effectiveness | The device should be as safe, as effective, and perform as well as the predicate devices. (Explicitly stated) | "Extensive biocompatibility, Usability, EMC and Environmental testing was conducted in accordance with ISO 10993, IEC 62366, IEC60601 (Edition 3) and MIL-STD 810F." |
| "Software validation testing was carried out as appropriate for a major level of concern device." | ||
| "GLP Animal data and Post Marketing Surveillance data were submitted in addition to the referencing of clinical data used to support the 510(k) clearance of the predicate device...No adverse events or complications were reported." |
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.
§ 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.