(210 days)
The FirstSave STAR Biphasic AED is designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias for patients older than eight years old. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to use of the device.
The FirstSave STAR Biphasic AED is a portable battery operated semi-automatic low power DC defibrillator. The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The operator then pushes the button to deliver the defibrillation shock. The FirstSave STAR Biphasic AED feature includes:
- . Biphasic defibrillation waveform
- . Lithium battery and battery fuel gauge
- Single user button .
- LED diagnostic panel ●
- Non-volatile status indicator ●
- Voice prompts .
The device weighs 7.4 lbs including battery, and electrodes with dimensions of 3.3in x 10.6in x 12.4in.
The provided text describes a 510(k) summary for the SurVivaLink FirstSave™ STAR Biphasic™ AED. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the device's diagnostic algorithm.
Here's an breakdown based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Rhythm Detection Accuracy | The device's diagnostic algorithm analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. |
| Efficacy of Biphasic Waveform | Found to be equivalent to the monophasic truncated exponential waveform in the FirstSave (a predicate device). |
| Compliance with AAMI DF39-1993 and AAMI DF2-1996 | Demonstrated that the device complies with the applicable sections. |
| EMC (Electromagnetic Compatibility) | Test results included. |
| Charge Time | Test results included. |
| Pulse Shape | Test results included. |
| Battery Capacity | Test results included. |
| Defibrillation Recovery | Test results included. |
| Hardware and Software Testing | Developed under design control and tested in accordance with established industry standards; design verification and validation data are included. |
| Environmental Tests | Performed on the finished device. |
| Safety and Effectiveness Equivalence | Demonstrated to be substantially equivalent to HeartStream's Forerunner and SurVivaLink's FirstSave AEDs. |
Missing Information:
- Specific quantifiable acceptance criteria for rhythm detection (e.g., sensitivity, specificity, accuracy thresholds for shockable vs. non-shockable rhythms).
- Quantifiable performance results for rhythm detection from a specific study. The text only states that the algorithm "analyzes" the rhythm and that the biphasic waveform was "found to be equivalent" in a clinical study for efficacy, not diagnostic accuracy of the rhythm analysis itself.
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "Clinical studies was performed to test the efficacy of the biphasic waveform." However, it does not provide any details regarding:
- The sample size (number of patients) used in this clinical study.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The text does not mention the number of experts used or their qualifications for establishing ground truth, particularly for the rhythm detection algorithm. The clinical study mentioned was for the efficacy of the biphasic waveform, not explicitly for validating the diagnostic algorithm's accuracy with expert-established ground truth.
4. Adjudication Method for the Test Set
The text does not provide any information about the adjudication method used for any test set or clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The text does not report on an MRMC comparative effectiveness study or any effect size indicating how much human readers improve with AI vs. without AI assistance. The device is described as a "semi-automatic" AED, meaning the device makes a recommendation, and the operator presses a button to deliver the shock. The focus here is on the device's diagnostic algorithm itself, not on assisting human readers in interpreting data.
6. Standalone (Algorithm Only) Performance
The device is described as having a "diagnostic algorithm that analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm." This implies a standalone algorithm's performance is central to the device's function. However, the document does not present a standalone performance study with specific metrics (like sensitivity, specificity, or accuracy) for this algorithm against a defined ground truth. Instead, it relies on demonstrating compliance with standards and equivalence to predicate devices. The clinical study mentioned focuses on the efficacy of the biphasic waveform, which is about the treatment's outcome, not necessarily the diagnostic accuracy of the rhythm analysis.
7. Type of Ground Truth Used
The text does not explicitly state the type of ground truth used for validating the rhythm detection algorithm. For the "efficacy of the biphasic waveform" study, the ground truth would likely be patient outcomes in response to defibrillation. For the diagnostic algorithm, ideal ground truth would be expert consensus on ECG rhythms, but this is not mentioned.
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for training the device's diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information on how ground truth was established for the training set.
Summary of Device Performance Claim:
The SurVivaLink FirstSave™ STAR Biphasic™ AED is positioned as substantially equivalent to its predicate devices (SurVivaLink's FirstSave and HeartStream Forerunner AEDs). The primary performance claims regarding the device's diagnostic algorithm are that it "analyzes the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm" and that the "biphasic waveform...was found to be equivalent to the monophasic truncated exponential waveform in the FirstSave." The submission emphasizes compliance with AAMI standards and various technical tests (EMC, charge time, etc.) rather than specific, quantified performance metrics for the diagnostic algorithm itself.
§ 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.