(40 days)
The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.
The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.
The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
The Powerheart® ECD is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive TFT color display for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation, cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR® Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm thermal printer, internal storage of event history and remote synchronization to bedside monitor.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them, especially in the format of a table with reported device performance. The document is a 510(k) summary for the Powerheart ECD, and it primarily focuses on device description, indications for use, and a statement of substantial equivalence to a predicate device based on functional and safety testing.
However, I can extract the information that is present and indicate what is missing.
Here's an attempt to structure the information based on your request, along with notes on what could not be found:
Acceptance Criteria and Study for Powerheart ECD
The document K060934 for the Powerheart ECD device does not explicitly detail specific quantitative acceptance criteria or a dedicated study report proving the device meets these criteria in the requested format. Instead, it states that "Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics." The conclusion is that modifications to the Powerheart ECD do not raise any new questions regarding safety or effectiveness compared to the predicate device (K052316), and it is substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Type | Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|---|
| Functional Characteristics | Demonstrated appropriate functional characteristics (Qualitative) | "Representative samples... underwent system, safety and bench testing... to demonstrate appropriate functional and performance characteristics." (Specific results not detailed) |
| Performance Characteristics | Demonstrated appropriate performance characteristics (Qualitative) | "Representative samples... underwent system, safety and bench testing... to demonstrate appropriate functional and performance characteristics." (Specific results not detailed) |
| Safety | Demonstrated safety (Qualitative) | "Modifications to the Powerheart ECD do not raise any new questions regarding the safety... as compared with the predicate device." (Specific results not detailed) |
| Effectiveness | Demonstrated effectiveness (Qualitative) | "Modifications to the Powerheart ECD do not raise any new questions regarding the... effectiveness as compared with the predicate device." (Specific results not detailed) |
| Substantial Equivalence | Substantially equivalent to predicate device K052316 in terms of indications for use, features, and functions. | The FDA granted 510(k) clearance, confirming substantial equivalence. |
| Specific Features | Not explicitly defined in the document | The document lists features like continuous ECG monitoring, defibrillation, cardioversion, external pacing, RHYTHMx® software, STAR® Biphasic waveform, etc., indicating these functions were tested as part of "functional and performance characteristics." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Representative samples of the device components underwent system, safety and bench testing," but the number of devices or data points used is not provided.
- Data Provenance: Not specified. The testing described is internal "system, safety and bench testing." No information on country of origin of data or whether it was retrospective or prospective is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the 510(k) summary. The testing appears to be primarily technical/engineering verification and validation, rather than clinical studies requiring expert ground truth establishment in a medical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided. Given the nature of the described testing (system, safety, bench testing), formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been relevant or used.
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 MRMC comparative effectiveness study is mentioned. The device, an Automated External Defibrillator with monitoring and pacing capabilities, is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. Its "RHYTHMx® software" provides ECG rhythm analysis, but the primary focus of the document is on the device's substantial equivalence in its overall function and safety, not on improving human reader performance with an AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies that the device's internal software (like RHYTHMx® for ECG rhythm analysis and STAR® Biphasic waveform for energy delivery) was tested as part of the overall "system, safety and bench testing." However, a separate "standalone" study specifically on the algorithm's performance independent of the full device's operation is not explicitly mentioned or detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided. For "system, safety and bench testing," the ground truth would typically be established by engineering specifications, validated test equipment, established physiological models, or comparison to known reference standards, rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
8. The sample size for the training set
- This information is not provided. The document does not describe the development or training of the RHYTHMx® software in detail. It only refers to its inclusion in the device.
9. How the ground truth for the training set was established
- This information is not provided. As no training set is described, the method for establishing its ground truth is also absent.
Summary of Missing Information:
The 510(k) summary provides a high-level overview of the device and claims substantial equivalence. It does not contain the detailed quantitative data from specific studies, sample sizes for test or training sets, details about expert involvement in ground truth establishment, or specific adjudication methods that would be expected for a more in-depth performance study, particularly for an AI/algorithm-focused device. The testing described is general "system, safety and bench testing" to ensure appropriate functional and performance characteristics and to demonstrate that the changes do not raise new safety or effectiveness concerns compared to the predicate device.
§ 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.