Search Results

The Heartstream FR2 is indicated for use on persons experiencing the symptoms of sudden cardiac arrest:

• Lack of responsiveness .
• . Lack of breathing

When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads. DO NOT DELAY TREATMENT TO DETERMINE THE CHILD'S EXACT AGE/WEIGHT.

The Heartstream FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support, advanced life support, or other physician-authorized emergency medical response.

The Heartstream FR2 is an automated external defibrillator available in two models, including one model with ECG display and manual shock capability. Features include self-testing, impedance-compensating biphasic truncated exponential waveform, multiparameter Patient Analysis System (PAS), and human factors design to facilitate use by lay responders.

A non-rechargeable lithium manganese dioxide battery powers the FR2 with a typical capacity of 300 shocks or 12 hours of operating time. An optional rechargeable lithiumion battery with a typical capacity of 100 shocks and 4 hours of operating time, and its companion charger, will also be available.

Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2 advises a shock and arms - if the ECG spontaneously converts to a nonshockable rhythm prior to a responder pressing the shock button, the FR2 disarms.

If significant artifact is detected in the ECG, Heartstream's PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2 directs the responder to press the shock button to deliver a biphasic shock to the patient.

Event and incident data can be recorded during FR2 use with an optional data card having a recording capacity of four hours of event and ECG data (or thirty minutes with voice recording).

The FR2 has an optional Training and Administration Pack that is used for device training and for customizing FR2 set-up options. Use of the Training and Administration Pack converts the FR2 to a training device with ten training "scripts" that simulate different SCA scenarios.

The FR2 also has an infrared communication port to facilitate communication of set-up parameters.

The provided text describes a 510(k) summary for the Heartstream FR2 AED but does not contain specific acceptance criteria or details of a study proving the device meets those criteria, beyond general statements about bench testing and simulated use testing.

Therefore, I cannot populate most of the requested sections with specific information. However, I can infer some general points from the document.

Here's an attempt to answer based on the provided text's limitations:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. It generally states that "Bench testing demonstrated that the performance of the M3848A and M3849A meets specifications" and "simulated use testing that the M3848A and M3849A are appropriate for the intended users." The focus of this 510(k) is on the substantial equivalence of a modified device (adding M3848A and M3849A accessories) to a predicate device, rather than a de novo submission that would typically detail extensive performance studies against new criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be accurately constructed from the given text.

Here's what can be extracted/inferred:

1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or detailed performance data are reported in this 510(k) summary. The summary only broadly states that the device "meets specifications" and is "appropriate for the intended users" based on testing.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing mentioned is "Bench testing" and "simulated use testing," implying laboratory or controlled environments, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. Given the nature of bench and simulated use testing for an AED, ground truth would likely be established through engineering specifications, simulated physiological responses, or adherence to established standards, rather than expert interpretation of patient data in the context of this 510(k) summary.

4. Adjudication method for the test set
Not specified.

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. This document describes an Automated External Defibrillator (AED), which is a standalone device for rhythm analysis and shocking. It does not involve "human readers" or "AI assistance" in the context of diagnostic image interpretation or similar tasks where MRMC studies are typically performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. An AED's primary function is to automatically analyze ECG and detect shockable rhythms. The summary states: "Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm." This confirms standalone algorithmic performance. The "simulated use testing" would likely evaluate this standalone performance in simulated scenarios.

7. The type of ground truth used
Not explicitly stated, but for an AED's rhythm analysis, ground truth would typically be based on:
* Defined ECG waveforms: Synthetic or recorded ECGs representing various rhythms (shockable, non-shockable, artifact) with known classifications.
* Physiological models: Simulated cardiac arrest scenarios where the "true" state of the heart rhythm is controlled.

8. The sample size for the training set
Not specified. This 510(k) focuses on a modification rather than the initial development of the core algorithm, so details on original training sets are not included.

9. How the ground truth for the training set was established
Not specified. For the original AED algorithm development, ground truth for training data would likely have been established by expert cardiologists or electrophysiologists annotating large databases of ECG recordings, often correlated with patient outcomes.

Ask a specific question about this device