(228 days)
The FirstSave STAR Biphasic AED is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The device is intended for use on persons older than eight years of age.
The FirstSave STAR Biphasic AED is a biphasic portable battery operated semiautomatic 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 feature includes: Lithium battery, Single user button for Rescue or Resume, LED diagnostic panel, Non-volatile status indicator, Voice prompts, Biphasic truncated exponential defibrillation waveform, RhythmX ECG analysis algorithm.
The provided 510(k) summary for the FirstSave STAR Biphasic AED (K011901) is a very brief document, typical for a submission from 2002. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general performance standards rather than providing detailed clinical study results with specific acceptance criteria and performance metrics often seen in more recent submissions.
Therefore, much of the requested information cannot be extracted from this document, as a specific "study" proving the device meets "acceptance criteria" with detailed performance outcomes is not described. Instead, the document states that "performance test data is provided in the 510(k) submission" and "Test data demonstrate that the safety and effectiveness... is substantially equivalent to the predicate device," without elaborating on the specific criteria or the exact results.
However, I can extract what is available and highlight what is missing based on your request.
Acceptance Criteria and Device Performance (Limited Information)
The document refers to compliance with industry standards rather than specific quantitative acceptance criteria with reported device performance.
| Acceptance Criterion (Reference Standard) | Reported Device Performance (as stated in document) |
|---|---|
| AAMI DF39-1993 (AED Standard) | Complies with applicable sections |
| IEC 601-2-4 (Medical Electrical Equipment) | Complies with applicable sections |
Note: The document states that the "performance test data is provided in the 510(k) submission" and covers "rhythm detection, EMC, charge time, pulse shape, battery capacity, defibrillation recovery, design verification and validation data for hardware and software." However, the specific acceptance criteria for these tests (e.g., "rhythm detection sensitivity must be >X%") and the reported device performance against those criteria are not detailed in this summary.
Study Information (Where available or noted as missing)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "rhythm detection" as part of the performance data but does not provide any specifics about a test set (e.g., number of ECGs, patient demographics, or data origin) or the study design (retrospective/prospective).
- For devices from this era, it was common for rhythm analysis algorithm testing to be done on existing ECG databases, but details are not provided here.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given the absence of details about a test set, there is no information on expert involvement for ground truth establishment.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
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 comparative effectiveness study is not mentioned. This type of study is typically associated with AI-assisted diagnostic tools that involve human interpretation, which is not the primary function of an AED's rhythm analysis algorithm. AEDs are designed for automated analysis and prompts.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "RhythmX ECG analysis algorithm" is described as analyzing the patient's cardiac rhythm to determine shockable versus non-shockable EKG rhythm. The mention of "rhythm detection" as part of the performance data implies a standalone evaluation of the algorithm's performance against a known truth (though the details of this evaluation are not provided in this summary). The device is "semi-automatic" meaning the algorithm makes the decision to advise a shock, and the operator manually delivers it.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. For rhythm detection in AEDs, ground truth is typically established by expert cardiologists reviewing the ECG tracings.
-
The sample size for the training set:
- Not specified. Training set details are not included in this summary.
-
How the ground truth for the training set was established:
- Not specified.
§ 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.