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The Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:

• Unresponsiveness .
• . Absence of normal breathing

If in doubt, apply the pads.

The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.

The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.

These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self tests performed each time the device is turned on, both models perform power on self tests, runtime self tests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.

The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card and various carry cases.

The provided text describes a 510(k) summary for Philips HeartStart AED models 861388 and 861389. However, it does not contain the specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on shared technology, specifications, and algorithms, rather than presenting a standalone performance study with detailed acceptance criteria and reported device performance metrics.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the given text. The document states that "Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness," but it does not present a table of specific acceptance criteria (e.g., sensitivity, specificity for shockable rhythm detection) or the corresponding numerical performance results for the device.

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

This information is not provided. The summary mentions "testing," but details about the sample size of the test set, its composition (e.g., number of ECGs, patient demographics), or the provenance (country of origin, retrospective/prospective) are omitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As no specific performance study with a test set and ground truth establishment is detailed, the number and qualifications of experts involved in such a process are not mentioned.

4. Adjudication method for the test set

This information is not provided. Without a detailed study description for a test set, the adjudication method for establishing ground truth is not discussed.

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

This information is not provided. The device is an Automated External Defibrillator (AED) with a "Patient Analysis System (PAS) algorithm for determining if the rhythm is shockable." This typically functions in a standalone capacity to advise the user to deliver a shock or not. The document does not describe a study involving human readers or their improvement with or without AI assistance, as it's not a diagnostic imaging AI tool.

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

Yes, implicitly. The document states "Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable." The primary function of an AED's algorithm is to analyze the rhythm and make a shock recommendation independently. The statement "Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates" suggests that the standalone performance of this algorithm was evaluated against the predicate devices' algorithms. However, the specific results and methodology of this standalone evaluation are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated. For AEDs, the ground truth for rhythm analysis (shockable vs. non-shockable) is typically established by expert cardiologists/electrophysiologists reviewing ECGs, often verified against clinical outcomes where available. However, the document does not specify how the ground truth was established for the "testing" performed.

8. The sample size for the training set

This information is not provided. The document focuses on demonstrating substantial equivalence and refers to the algorithm as existing (from predicate devices or similar technology), but it does not provide details about the training set used for the algorithm's development.

9. How the ground truth for the training set was established

This information is not provided. Similar to the training set size, the method for establishing ground truth for the training data is not discussed in this 510(k) summary.

In summary, the provided content is a high-level 510(k) summary focusing on substantial equivalence to predicate devices, rather than a detailed report of a specific study that outlines acceptance criteria and performance metrics. It confirms that "testing" was done to show equivalence, but it omits the granular details of those tests, including specific performance data, sample sizes, and ground truth methodologies.

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