(162 days)
The HeartStart Home Defibrillator should be used to treat someone who you think may be a victim of sudden cardiac arrest. A person in sudden cardiac arrest:
- does not respond when shaken, and .
- . is not breathing normally.
If in doubt, apply the pads.
The HeartStart Home Defibrillator was designed to be safe, easy and ready to use. Features of the HeartStart Home Defibrillator include self-testing and self-calibration, an impedance-compensating biphasic truncated exponential therapy waveform, a multiparameter ECG analysis system for determining if a shock is required, and an integrated human factors design to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the HeartStart Home Defibrillator with a minimum capacity of 90 shocks and 3 hours of operating time.
The HeartStart Home Defibrillator monitors the progress of the rescue and issues voice instructions as appropriate, keeping pace with the user. The defibrillator incorporates a shock-delivery protocol that pauses at predefined intervals to allow users to deliver CPR, with CPR coaching available. Except during these pause intervals for CPR, the defibrillator continuously and automatically analyzes the patient's ECG to determine if a shock is needed. The defibrillator incorporates technologies that assess the ECG validity using both common mode and differential mode signals; these technologies were designed to ensure that a shock is not advised unless the defibrillator is applied to a patient in a shockable heart rhythm.
The HeartStart Home Defibrillator utilizes the same biphasic, impedance-compensating exponential waveform used in previous-generation Philips AEDs. With the standard pads cartridge installed, the HeartStart Home Defibrillators delivers 150J shocks (nominal) after a shockable rhythm has been detected, and the user presses the shock button as instructed by the defibrillator. The HeartStart Home Defibrillator offers no manual-shock capability.
Here's a breakdown of the acceptance criteria and study information for the Philips HeartStart Home Defibrillator, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it focuses on demonstrating safety, usability, and effectiveness through various studies. The reported performance is primarily qualitative regarding safe and successful use.
| Acceptance Criterion (Inferred from studies) | Reported Device Performance (as described in the document) |
|---|---|
| Safe Use by Lay Responders | Used safely by all participants in Safety and Usability Study (n=124). All participants in mock-rescue portion of Labeling Evaluation used the defibrillator safely (n=178). All participants in Design Validations (adult n=20, infant/child n=10) used the defibrillator safely. |
| Successful Use by Lay Responders | Successfully used by both naïve and video-trained volunteers at 87% (n=61) and 89% (n=63) respectively in Safety and Usability Study. Majority able to use successfully in Labeling Evaluation (97% for Quick Reference Guide, 83% for Owner's Manual). All participants in adult use scenario of Design Validations used the defibrillator successfully. |
| Understanding of Labeling | All four major HeartStart Home labeling materials were well understood in the Labeling Evaluation (n=353). |
| Performance of ECG Analysis System | Sensitivity and specificity of the ECG analysis system demonstrated in bench and field studies in previous 510(k) submissions. (Specific numbers not provided in this document). |
| Effectiveness of Biphasic Waveform | Safety and effectiveness of the 150J biphasic waveform demonstrated in clinical trials and field studies included in previous 510(k) submissions. (Specific outcomes not provided in this document). |
| No Unreported Safety/Effectiveness Issues | Confirmed by Lay User Survey of existing ForeRunner and FR2 home and business customers. |
2. Sample Size Used for the Test Set and Data Provenance
- Safety and Usability Study: 124 volunteers. Data provenance is prospective (participants actively performing mock rescues). Country of origin is not explicitly stated but implies within the US, given the FDA filing.
- Labeling Evaluation: 353 participants for the comprehension test, 178 of whom participated in the mock-rescue scenario. Data provenance is prospective. Country of origin is not explicitly stated.
- Design Validations: Adult use (n=20), infant/child use (n=10). Data provenance is prospective. Country of origin is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Explicit mention of experts establishing ground truth for the test set (i.e., the usability studies and labeling evaluations) is not present. The studies assessed lay user performance against predefined safety and success criteria, rather than an expert determining the "correctness" of a diagnosis or treatment by the device or user in real-time.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the test sets. The studies appear to have directly measured participant performance against established metrics for safe and successful device use.
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 described. The studies focused on the standalone performance and usability of the device by laypersons. This device is an Automated External Defibrillator (AED), which is designed for automated analysis and instruction, not for human "reading" or interpretation in the same way as an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the effectiveness of the device's core algorithms (ECG analysis system and biphasic waveform) was established in prior standalone studies, as referenced:
- "Similarly, the sensitivity and specificity of the ECG analysis system used in the HeartStart Home Defibrillator was demonstrated in bench and field studies in previous 510(k) submissions."
- "The safety and effectiveness of the 150J biphasic waveform used in the HeartStart Home Defibrillator was demonstrated in clinical trials and field studies included in previous 510(k) submissions."
The current submission references these past studies rather than conducting new standalone algorithm performance studies. Specific details like sample sizes and exact ground truth methods for these prior standalone studies are not available in this document.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the usability/labeling studies: Ground truth was essentially the predefined criteria for safe operation and successful completion of mock-rescue tasks. It's a performance-based "ground truth" rather than a medical diagnosis.
- For the ECG analysis system: The document states sensitivity and specificity were demonstrated in past studies, implying a ground truth of actual cardiac rhythm (e.g., shockable vs. non-shockable) established by medical experts or confirmed by other diagnostic means.
- For the biphasic waveform: The document refers to "clinical trials and field studies," suggesting ground truth tied to patient outcomes (e.g., return of spontaneous circulation, survival) or physiological measures.
8. The Sample Size for the Training Set
No information is provided regarding a "training set" in the context of machine learning. The device's algorithms (ECG analysis) were likely developed and validated using a dataset of ECGs, but this document does not detail their development or specific training set sizes. The studies described here are validation/testing studies for the device's overall performance and usability, not for algorithm training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in this document, the method for establishing its ground truth is not provided.
§ 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.