(274 days)
The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse.
The ForeRunner external defibrillator is a semi-automatic external defibrillator incorporating voice prompts to advise the operator of the need to deliver a defibrillating shock. The device is designed to be used by emergency responders in the treatment of cardiac arrest. The device is portable, weighing approximately 4 pounds and measuring approximately 2.5"(H) x 8"(W) x 8.8"(D). The ForeRunner product line consists of the defibrillator, a disposable battery, a pack of disposable single use electrodes, carrying cases and other optional accessories, such as event recording data cards and event review software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Heartstream ForeRunner External Defibrillator:
The provided text is a 510(k) Summary of Safety and Efficacy, which is a premarket submission to the FDA. While it discusses "testing" and "evaluation," the level of detail provided is typical for a 510(k) and significantly less granular than what would be found in a detailed clinical trial report or a comprehensive technical specification document.
Based on the provided text, the specific details required for your request are largely not explicitly stated. The summary focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing specific performance metrics against pre-defined acceptance criteria with the rigor of a clinical study report.
Here's what can be extracted and inferred, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ECG recognition algorithm evaluation (accuracy/performance) | "evaluated using recordings of actual cardiac signals in accordance to established industry standards." (Specific metrics like sensitivity, specificity, accuracy, or minimum acceptable performance are not provided.) |
| Software validation | "validated per recognized validation techniques." (Specific acceptance criteria for software functionality, robustness, or reliability are not provided.) |
| Biocompatibility of electrodes | "performed on patient contact materials of defibrillation electrodes in accordance to international standards." (Specific acceptance criteria for biocompatibility endpoints like cytotoxicity, irritation, or sensitization are not provided, nor are the results.) |
| Environmental and performance tests (e.g., durability, electrical safety, energy delivery accuracy) | "Extensive environmental and performance tests are conducted...in accordance to established industry standards." (Specific acceptance criteria or detailed performance results are not provided beyond 'acceptable results'. This likely refers to standards like IEC 60601-1 and related defibrillator-specific standards.) |
| Defibrillation waveform effectiveness and safety | "The defibrillation waveform has been shown to be substantially equivalent to predicate product waveform with respect to defibrillation effectiveness and safety in an extensive clinical trial." (Specific acceptance criteria for effectiveness (e.g., first-shock success rate) or safety (e.g., adverse event rates) are not provided for the ForeRunner itself, only its equivalence to a predicate.) |
2. Sample Size Used for the Test Set and Data Provenance
- ECG Recognition Algorithm: "recordings of actual cardiac signals".
- Sample Size: Not stated.
- Data Provenance: Not explicitly stated, but "actual cardiac signals" implies clinical data, likely from various sources following recognized standards for defibrillator algorithm testing (e.g., AHA/ACC/HRS guidelines for arrhythmia detection). It's most likely retrospective recordings collected for such purposes.
- Defibrillation Waveform Clinical Trial: "extensive clinical trial."
- Sample Size: Not stated.
- Data Provenance: Not explicitly stated, but "clinical trial" implies prospective human subject data. Country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- ECG Recognition Algorithm: Not stated. For ECG algorithm validation using "actual cardiac signals," ground truth is typically established by expert cardiologists or electrophysiologists reviewing and annotating the ECG waveforms. The number and specific qualifications are not mentioned.
- Defibrillation Waveform Clinical Trial: For the "extensive clinical trial" assessing defibrillation effectiveness and safety, ground truth for outcomes (e.g., successful defibrillation, return of spontaneous circulation, adverse events) would be established by the treating clinicians and study investigators. The number and specific qualifications are not stated.
4. Adjudication Method for the Test Set
- Not stated for any of the described evaluations. If multiple experts were involved in establishing ground truth (e.g., for ECG signal classification), common methods include consensus, majority vote (e.g., 2+1), or a senior adjudicator. This information is absent.
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 study is not mentioned. This device is a semi-automatic external defibrillator designed to provide voice prompts and independently analyze the ECG for shockable rhythms. It's not an AI-assisted diagnostic tool that human "readers" (like radiologists or cardiologists interpreting images/signals) would use to improve their own performance. The device itself makes the "decision" to advise a shock based on its algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "ECG recognition algorithm" was "evaluated using recordings of actual cardiac signals." This evaluation would assess the algorithm's performance standalone in identifying shockable rhythms, forming the core of the device's automated function. The voice prompts are the "human-in-the-loop" interface, advising the operator to press the shock button, rather than the operator interpreting complex data.
7. The Type of Ground Truth Used
- ECG Recognition Algorithm: The ground truth for classifying "actual cardiac signals" (ECGs) as shockable or non-shockable would be expert consensus by cardiologists/electrophysiologists based on established criteria for arrhythmias like Ventricular Fibrillation (VF) or Pulseless Ventricular Tachycardia (pVT).
- Defibrillation Waveform Clinical Trial: The ground truth for effectiveness and safety in the "extensive clinical trial" would be clinical outcomes data, such as successful termination of arrhythmia, return of spontaneous circulation (ROSC), and documented adverse events.
8. The Sample Size for the Training Set
- Not stated. The document mentions the evaluation of the algorithm and a clinical trial, but no details are provided about the training data used to develop the ECG recognition algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not stated. Assuming a supervised learning approach for the ECG algorithm (which is typical for such devices), the ground truth for the training set would have been established by expert cardiologists or electrophysiologists annotating a large dataset of ECG recordings, similar to how the ground truth for an independent test set would be established.
§ 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.