(145 days)
The Powerheart AED is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.
The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.
When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.
The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy.
The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.
The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring.
The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart AED with Model 9730 Pediatric Attenuated Defibrillation Electrodes:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than setting specific numerical acceptance criteria and reporting performance against them in a detailed table.
Instead of explicit acceptance criteria, the document states:
| Category | Acceptance "Criteria" (Implicit) | Reported Device Performance |
|---|---|---|
| General Performance | Designed in accordance with industry standards ANSI AAMI DF-39. | "The Powerheart AED with the Model 9730 electrodes were found to perform as intended." |
| Biocompatibility | Biocompatibility assessments conducted on components in contact with patient's skin. | "biocompatibility assessments were conducted... The Powerheart AED with the Model 9730 electrodes were found to perform as intended." |
| Substantial Equivalence | Equivalent to predicate device (Agilent Technologies FR2 AED with M3870A Pediatric Attenuated Defibrillation Electrodes) in intended use, technological characteristics, materials, function, safety, and effectiveness. | "Cardiac Science has demonstrated through its evaluation and testing... that the device is equivalent to the predicate device with respect to intended use, technological characteristics, materials, function and safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a sample size for any clinical testing or specific test sets for performance evaluation. The performance section mentions "Performance testing" but does not detail the nature or scope of this testing in terms of sample size for patients or data.
- Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It primarily refers to "performance testing" and "evaluations and testing" without further detail.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically found in clinical trial reports or detailed validation studies, which are not included in this 510(k) summary. Given the nature of a defibrillator (delivering an electric shock rather than diagnosing a complex condition), the "ground truth" for its primary function (delivering a shock when indicated) would be based on its ability to classify rhythms accurately and deliver the correct energy, which is usually assessed through engineering and electrical performance testing against established standards, rather than expert interpretation of patient data in a "test set" paradigm as one might see for an AI diagnostic device.
4. Adjudication Method for the Test Set:
Since the document does not describe a clinical test set with human interpretation or expert evaluation, no adjudication method is mentioned or implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic AI devices where human interpretation is involved. The Powerheart AED is a device that autonomously analyzes rhythms and advises on shock delivery, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study in the traditional sense of an AI algorithm (i.e., algorithm only without human-in-the-loop performance) was not explicitly described in terms of a separate clinical study. However, the "Performance testing" conducted to verify compliance with ANSI AAMI DF-39 would have essentially evaluated the device's (including its embedded algorithm's) ability to diagnose rhythms and deliver appropriate therapy without human intervention in terms of the core defibrillation function. The summary itself does not detail the methodology or results of this testing.
7. Type of Ground Truth Used:
The primary "ground truth" for a defibrillator typically comes from:
- Physiological/Electrical Standards: The ability to accurately detect shockable rhythms (e.g., ventricular fibrillation, ventricular tachycardia) and non-shockable rhythms, and to deliver energy within specified parameters. This is governed by industry standards like ANSI AAMI DF-39.
- Predicate Device Equivalence: The performance of a legally marketed predicate device (Agilent Technologies FR2 AED with M3870A Pediatric Attenuated Defibrillation Electrodes).
The document states that performance testing was conducted according to ANSI AAMI DF-39, implying that the "ground truth" for this testing would be based on the requirements and test methods outlined in that standard to ensure the device performs its intended functions correctly.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. This is expected as the Powerheart AED is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to develop its diagnostic capabilities. Its rhythm analysis is based on pre-programmed algorithms and signal processing, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set in the context of machine learning, there is no information on how a "ground truth for the training set" was established. The device's functionality is verified against established engineering and medical device standards.
§ 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.