Search Results

To power AEDs for which the OEM battery pack was intended. Only qualified service personnel should evaluate, test, or install AED battery packs.

To provide power for the specific Automated External Defibrillators (AEDs) for which the original battery packs were designed and manufactured, in back-up and portable use.

The Green4Life Batteries are non-rechargeable battery packs utilized as the primary power source or as a standby or backup power source for Automated External Defibrillators (AEDs). These devices provide a means of supplying electrical power through the chemical reaction of lithium cells. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current required by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and discharge method. The goal of these battery packs is to provide a sufficient power source for AEDs for as long as possible under a specified range of environmental conditions.

The Green4Life Batteries are re-celled battery packs of those identified below in Predicate Devices.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Acceptance Criteria:

• Ease of Installation: Battery pack must easily install into the AED and firmly lock into place as with the original battery pack.
• AED Self-Test Result: Upon installation, the AEDs undergo an operational self-test of the installed battery, and the final battery pack acceptance testing requires a reported "pass" by the corresponding AED.

Reported Device Performance: The document states, "The Green4Life Battery packs are re-celled packs manufactured as cleared devices... Performance testing within the specific AED was conducted to verify that the replacement battery pack tested within limits and that reset of battery pack information when operated within the designated AED, for those packs equipped with memory devices, was acceptable." It also states, "Final battery pack acceptance testing requires a reported 'pass' by the corresponding AED." This implies that all stated acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a specific numerical sample size for the "Performance Testing" or "Manufacturing Tests," but it implies testing each battery pack. It mentions "typical sampling plans for similar devices" for incoming inspection of lithium cells, and "100% testing" for assembled packs. For the final acceptance test, "the battery packs will be installed into their corresponding AED for a final acceptance test." This suggests that a representative number of each re-celled battery model were tested.
• Data Provenance: The testing was conducted by AED Battery Exchange, LLC. The data provenance is internal to the manufacturer, intended to demonstrate equivalence to predicate devices. It is a form of prospective testing for the manufactured re-celled batteries. The company is based in Wauconda, IL, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• This information is not applicable to this type of device and study. The "ground truth" for battery performance is objective and measurable (voltage, resistance, successful AED operation), not based on expert interpretation like in image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reads) where disagreements between experts need resolution. For objective measurements like battery performance, the results are definitive.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This submission pertains to a re-celled battery pack.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, in essence, standalone testing was done for the battery's performance. The core tests (open circuit voltage, loaded circuit voltage) are performed directly on the battery packs without human intervention beyond setting up the test equipment and recording results. The "final acceptance test" involves the AED's internal self-test, which is an automated algorithm checking the battery's functionality. This is the "algorithm only" aspect of performance evaluation for this type of device.

7. The Type of Ground Truth Used

• The ground truth is based on objective, measurable electrical parameters (voltage under open and loaded conditions) and functional validation (the AED's internal self-test reporting "pass"). This is a form of empirical validation against defined performance specifications.

8. The Sample Size for the Training Set

• This information is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for the manufacturing process is adherence to established specifications and procedures for re-celling and testing.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable for the same reason as point 8. The "ground truth" for the manufacturing process is the successful replication of original battery performance, which is verified by the performance tests described in the acceptance criteria.

Ask a specific question about this device

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

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.

Ask a specific question about this device