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The FR3 is 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 FR3 is 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 FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Kev 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.

The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always.

WARNING: Performance of the SMART CPR AUTOI and AUTO2 settings for the CPR First feature has not been established in patients under 55 1b (25 kg) or 8 years old.

CPR Meter with Q-CPR:
The FR3 can be used with the optional CPR meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.

WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.

When attached to the bare chest of a suspected victim of SCA and connected to an FR3 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR.

3-Lead ECG Cable:
In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic ECG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors I. II. or III. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the FR3 alerts the responder to check the patient if the ECG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate.

FR3 Rechargeable Battery:
The FR3 rechargeable battery is intended for use by organizations, such as EMS or fire departments that use the FR3 frequently and want to decrease cost-per-use and reduce environmental waste. The rechargeable battery should only be used by organizations committed to providing the resources required to operate a battery maintenance program. Due to changes in the performance characteristics of rechargeable batteries over time, it is important for the battery maintenance program to monitor how many battery charge/discharge cycles the battery experiences, in order to determine when to retire it from service. The FR3 rechargeable battery is not recommended for infrequent-use environments such as office buildings, airlines, or public access defibrillation (PAD) programs. It should not be used as the spare or backup battery; instead, the standard primary battery should be used due to its long shelf-life.

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 Philips SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithm 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 selftests, 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 an optional rechargeable Clinical Use Battery, an optional 3-Lead ECG Cable, an optional CPR Meter with Q-CPR Technology, and various carry cases.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

The provided text (K130684) for the Philips HeartStart FR3 AED models 861388 and 861389 primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's enhanced features and accessories. Crucially, it does not contain a dedicated section outlining specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its core functionality (like the Patient Analysis System algorithm) or a study report explicitly detailing how these criteria were met.

Instead, the submission relies on the concept of substantial equivalence to previously cleared devices. This means that the core safety and performance characteristics are assumed to be similar to the predicates because the underlying technologies (waveform, Patient Analysis System algorithm, SMART CPR algorithm) are unchanged from a prior 510(k) clearance (K111693). New accessories and features are also claimed to be "within the predicate device functionality."

Therefore, much of the requested information regarding acceptance criteria and a specific study proving those criteria are met for the core AED functionality cannot be extracted directly from this document. The information it does provide largely pertains to the supplementary accessories and the general claim of equivalence.

Here's the breakdown of the information you requested, based only on the provided text. Where information is not present, it will be explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As described above, this document does not explicitly state quantitative acceptance criteria or a specific performance study for the core defibrillation algorithm (Patient Analysis System) for K130684. It relies on the substantial equivalence to a prior 510(k) (K111693) where those criteria would have presumably been established and met.

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

The document does not specify a separate "test set" or its sample size for the core AED functionality in the context of K130684. It relies on the prior clearance (K111693) for validation of the core algorithm.

For the new accessories:

• CPR Meter with Q-CPR Technology: The claim is that performance is "similar" to predicate devices (Laerdal Medical CPRmeter K122050, Philips Compression Sensor with MRx K051134). No new specific test set or data provenance is detailed for K130684, implying it leverages the validation from those predicate devices.
• 3-Lead ECG Cable: No specific test set data is provided in this document. The functionality is described, but not a study proving its performance against acceptance criteria.

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

This information is not provided in the K130684 document. This would typically be part of the original validation study for the Patient Analysis System algorithm, which occurred during the clearance of the predicate device K111693.

4. Adjudication Method for the Test Set

This information is not provided in the K130684 document. This would typically be part of the original validation study for the Patient Analysis System algorithm, which occurred during the clearance of the predicate device K111693.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the K130684 document. Medical devices like AEDs typically perform analysis and advise actions (shock/no shock) autonomously, rather than assisting a human "reader" in interpreting data in the way an AI diagnostic tool might. The CPR meter provides real-time feedback to assist human responders, but an MRMC study demonstrating improvement with AI assistance is not described.

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

The primary functionality of the AED (the "Patient Analysis System algorithm for determining if the rhythm is shockable") is inherently a standalone algorithm-only function. The device makes the shock/no-shock decision based on its analysis. However, this specific 510(k) (K130684) does not detail a new standalone study for this algorithm; it relies on the fact that the algorithm is unchanged from previous clearances.

7. The Type of Ground Truth Used

This information is not provided in the K130684 document. For AEDs, ground truth for rhythm analysis (shockable vs. non-shockable) typically comes from expert electrophysiologist consensus interpretation of ECG tracings or, in some cases, clinical outcomes. This would have been established during the validation of the original Patient Analysis System algorithm in the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the K130684 document. The document states the "Patient Analysis System algorithm... are also unchanged" from K111693, implying any training would have occurred for that prior submission.

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

This information is not provided in the K130684 document. As with the test set ground truth, this would have been established during the original algorithm development and validation for the predicate device K111693.

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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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