(149 days)
The Powerheart® AED G3 Pro, model 9300P, is intended to be used 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 tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.
When a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro 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.
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.
The Powerheart® AED G3Pro is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart@ AED G3Pro also has an ECG display and manual override for advanced users. The device in this submission is equivalent to the current Powerheart® ABD and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K982710 and K031987. The reason for this premarket notification is to introduce the semi-sutomatic
The provided text is a 510(k) summary for the Cardiac Science Powerheart® AED G3 Pro. This document establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a new, de novo device might. Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics are not explicitly available or are presented indirectly through the claim of substantial equivalence.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or positive predictive value. Instead, it asserts that the device modifications (ECG display and manual override) had "no affect on the safety or effectiveness of the device" and that the "device was found to perform as intended." This is based on comparative testing against predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "No affect on the safety or effectiveness of the device" due to modifications. "Found to perform as intended." |
| Equivalence to Predicates | "Equivalent to the current Powerheart® AED and the Philips Medical Systems Heartstream FR2 AED" regarding "indications for use, technological characteristics, and software algorithm." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "performance software and hardware evaluations" and "testing" but does not specify:
- The sample size for any test set (e.g., number of patients, number of ECG events).
- The data provenance (country of origin, retrospective or prospective nature of data collection).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide details about how ground truth was established for any performance testing, nor does it mention the number or qualifications of experts involved in such a process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for a test set.
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
The document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The device is an AED, and the modifications discussed relate to an ECG display and manual override, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that the Powerheart® AED G3Pro is a "semi-automatic" device, meaning it diagnoses and may advise shock delivery but requires operator action (human-in-the-loop) for therapy. While it performs internal diagnostic algorithms ("software algorithm"), the summary does not detail a standalone algorithm performance study independent of the complete device operation. The focus is on the device as a whole and its equivalence to predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any testing. For an AED, ground truth would typically relate to the presence or absence of a shockable rhythm verified by expert cardiologists or electrophysiologists based on ECG analysis or patient outcomes.
8. The sample size for the training set
The document does not refer to a "training set" or provide any sample size for training data. As this is a 510(k) for a device claiming substantial equivalence, the focus is on comparative testing rather than a de novo algorithm development and training process.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
Summary of the Study:
The "study" described in this 510(k) notification is primarily a comparative equivalency assessment against previously cleared predicate devices. The modifications introduced in the Powerheart® AED G3 Pro (ECG display and manual override) were evaluated through "performance software and hardware evaluations" and "testing." The reported conclusion is that these modifications did not affect the safety or effectiveness of the device, and it performs as intended, being substantially equivalent to the Powerheart® AED G3 (K031987) and the Philips Medical Systems Heartstream FR2 (K014157, K013425). Specific quantitative performance metrics, detailed study designs, sample sizes, and ground truth methodologies are not provided in this summary, as is typical for 510(k) submissions focusing on substantial equivalence.
§ 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.