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The Powerheart® AED G3 Pro, model 9300P, 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 tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

The Powerheart® AED G3Pro is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart@ AED G3Pro also has an ECG display and manual override for advanced users. The device in this submission is equivalent to the current Powerheart® ABD and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K982710 and K031987. The reason for this premarket notification is to introduce the semi-sutomatic

The provided text is a 510(k) summary for the Cardiac Science Powerheart® AED G3 Pro. This document establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a new, de novo device might. Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics are not explicitly available or are presented indirectly through the claim of substantial equivalence.

Based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or positive predictive value. Instead, it asserts that the device modifications (ECG display and manual override) had "no affect on the safety or effectiveness of the device" and that the "device was found to perform as intended." This is based on comparative testing against predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "performance software and hardware evaluations" and "testing" but does not specify:

• The sample size for any test set (e.g., number of patients, number of ECG events).
• The data provenance (country of origin, retrospective or prospective nature of data collection).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide details about how ground truth was established for any performance testing, nor does it mention the number or qualifications of experts involved in such a process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for a test set.

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

The document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The device is an AED, and the modifications discussed relate to an ECG display and manual override, not an AI-assisted diagnostic tool for interpretation by human readers.

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

The document states that the Powerheart® AED G3Pro is a "semi-automatic" device, meaning it diagnoses and may advise shock delivery but requires operator action (human-in-the-loop) for therapy. While it performs internal diagnostic algorithms ("software algorithm"), the summary does not detail a standalone algorithm performance study independent of the complete device operation. The focus is on the device as a whole and its equivalence to predicates.

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

The document does not specify the type of ground truth used for any testing. For an AED, ground truth would typically relate to the presence or absence of a shockable rhythm verified by expert cardiologists or electrophysiologists based on ECG analysis or patient outcomes.

8. The sample size for the training set

The document does not refer to a "training set" or provide any sample size for training data. As this is a 510(k) for a device claiming substantial equivalence, the focus is on comparative testing rather than a de novo algorithm development and training process.

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

Summary of the Study:

The "study" described in this 510(k) notification is primarily a comparative equivalency assessment against previously cleared predicate devices. The modifications introduced in the Powerheart® AED G3 Pro (ECG display and manual override) were evaluated through "performance software and hardware evaluations" and "testing." The reported conclusion is that these modifications did not affect the safety or effectiveness of the device, and it performs as intended, being substantially equivalent to the Powerheart® AED G3 (K031987) and the Philips Medical Systems Heartstream FR2 (K014157, K013425). Specific quantitative performance metrics, detailed study designs, sample sizes, and ground truth methodologies are not provided in this summary, as is typical for 510(k) submissions focusing on substantial equivalence.

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The Powerheart® AED G3A 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 tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3A should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3A is a portable, battery-operated, fully-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart® AED device in this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K 982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device.

This product is an Automated External Defibrillator. The provided 510(k) summary (K040438) primarily focuses on establishing substantial equivalence to previously cleared AEDs, rather than presenting detailed new clinical study data with specific acceptance criteria and detailed performance metrics of the device as an AI-powered diagnostic tool. This is a common approach for device modifications or new versions of established devices when the underlying technology (e.g., software algorithm) remains the same or only minimally altered without impacting safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of acceptance criteria and the reported device performance

Based on the provided K040438 summary:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state a sample size for a "test set" in the context of diagnostic accuracy, nor does it detail data provenance. The testing mentioned refers to "performance software evaluations." This suggests testing of the software's functionality and adherence to specifications, rather than a clinical trial with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The submission does not describe a study involving expert-established ground truth for a test set of patient data. The evaluation appears to be internal software testing and comparison to predicate devices, not a diagnostic accuracy study using a panel of experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a test set requiring adjudication by experts.

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. The K040438 summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. AEDs like the Powerheart AED G3A are designed to automatically detect and advise on shockable rhythms, and in this fully-automatic version, they also deliver the therapy automatically. The role of "human readers" in the context of an MRMC study for an AED's primary function is not typically applicable in the same way as for image-based diagnostic AI.

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

Yes, in essence, the "performance software evaluations" and the device's inherent design as a "fully-automatic" AED (meaning it diagnoses and delivers shock energy autonomously) can be considered a standalone performance assessment. The device's primary function is to operate independently of real-time human diagnostic input.

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

The ground truth for the software evaluations would have been based on established engineering and cardiac rhythm analysis standards, likely involving:

• Simulated ECG waveforms: Known waveforms (shockable vs. non-shockable) would have been input to verify correct classification and action.
• Performance standards: Adherence to established standards for defibrillator performance (e.g., energy delivery, charge time, shock advisory accuracy).
• Predicate device's algorithm performance: The software algorithm is stated to be "identical... as the current commercially distributed Powerheart® AED," implying that the ground truth for its core functionality would have been established during the clearance of prior versions.

8. The sample size for the training set

The document does not specify a training set sample size. Given that the software algorithm is "identical... as the current commercially distributed Powerheart® AED," it implies the training (if any Machine Learning was involved, which is less common for traditional AED algorithms relying on rule-based detection) would have occurred for previous versions, and this submission is primarily about hardware/operational modifications (fully-automatic functionality) and demonstrating the continued validated performance of the existing algorithm.

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

Not explicitly stated for this particular submission, as it focuses on equivalence. For the original development of an AED's rhythm analysis algorithm, the ground truth for a training set (if applicable) would typically be established by:

• Expert cardiologists/electrophysiologists: Annotation of ECG recordings to identify shockable rhythms (e.g., ventricular fibrillation, pulseless ventricular tachycardia) and non-shockable rhythms.
• Clinical outcomes data: Correlation of algorithm's outputs with actual patient outcomes (e.g., successful defibrillation, survival).
• Standardized databases: Use of well-characterized ECG databases (e.g., AHA/MIT-BIH) with expert-verified annotations.

In summary, this 510(k) submission for the Powerheart® AED G3A is primarily a declaration of substantial equivalence to previously cleared AEDs, particularly a fully-automatic version from another manufacturer, and a semi-automatic version of their own device. The performance testing described focuses on software functionality and ensuring that the conversion to fully-automatic operation did not negatively impact safety or effectiveness, rather than a de novo clinical study establishing diagnostic accuracy with a new AI algorithm.

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The Powerheart® AED G3 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 tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3 should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3 is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® AED G3:

Overview:
It's important to note that this 510(k) submission (K031987) is for minor modifications and a software upgrade to an already cleared device. The submission explicitly states: "The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software." and "The device modifications do not raise any new issues of safety or effectiveness."

Because of this, the submission doesn't detail a comprehensive new study to establish initial performance metrics but rather to demonstrate that the modifications did not negatively impact the device's existing established performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., Sensitivity > X%, Specificity > Y%). Instead, the "acceptance criteria" appear to be that the modified device performs as intended and that the modifications had no affect on the safety or effectiveness of the device.

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

The document does not specify a distinct "test set" with a defined sample size for clinical or algorithm performance evaluation in this submission. The testing conducted was described as "performance hardware and software evaluations."

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or ECGs. The text refers to "performance hardware and software evaluations," which are typically done on the device itself through engineering and verification methods rather than biological data sets.
• Data Provenance: Not applicable/not specified for this type of evaluation. The "testing" appears to be internal engineering and verification, not clinical data evaluation for algorithm performance on patient data.

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

Not applicable. This submission focuses on hardware and software verification of minor changes, not the establishment of ground truth for a diagnostic algorithm using expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was not a study involving expert adjudication of a test set of clinical data.

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 does not describe an MRMC comparative effectiveness study. The device is an Automatic External Defibrillator (AED), which is largely an automated system designed for lay rescuers or personnel trained in its operation, not for human readers to interpret complex images or data with AI assistance. Its primary function is automated rhythm analysis and shock advisory.

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

The performance testing described ("performance hardware and software evaluations") would implicitly cover the standalone performance of the algorithm within the device. The "algorithm" for an AED is its ability to accurately detect shockable rhythms (like Ventricular Fibrillation or Ventricular Tachycardia) and differentiate them from non-shockable rhythms. While the document doesn't provide specific standalone sensitivity and specificity numbers, the statement "The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended" implies that its rhythm analysis algorithm (the core of a standalone AED) met its specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of ground truth used for the algorithm's rhythm analysis performance. For AEDs, the ground truth for rhythm analysis (e.g., shockable vs. non-shockable) is typically established by expert cardiologists or electrophysiologists independently reviewing ECG recordings and classifying them. However, for this specific 510(k) (minor changes), the ground truth for the original algorithm's performance would have been established in prior submissions (K022929, K011901, K982710). This submission primarily focuses on demonstrating that the minor modifications did not degrade that previously established performance.

8. The Sample Size for the Training Set

Not applicable/not specified for this submission. The training set for the original AED algorithm would have been part of the initial development and validation process for the predicate devices. This 510(k) is about modifications to an existing device, not the development of a new algorithm requiring a new training set.

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

Not applicable/not specified. Similar to the test set, the ground truth for the training set (if the algorithm used machine learning, which was less common for AEDs in 2003, but still relevant) would have been established during the development of the original predicate devices, likely through expert review of ECG waveforms.

Ask a specific question about this device

The Powerheart AED is intended for use 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.

When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy.

The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform.

The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring.

The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart AED with Model 9730 Pediatric Attenuated Defibrillation Electrodes:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than setting specific numerical acceptance criteria and reporting performance against them in a detailed table.

Instead of explicit acceptance criteria, the document states:

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

• Sample Size for Test Set: The document does not specify a sample size for any clinical testing or specific test sets for performance evaluation. The performance section mentions "Performance testing" but does not detail the nature or scope of this testing in terms of sample size for patients or data.
• Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It primarily refers to "performance testing" and "evaluations and testing" without further detail.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of detail is typically found in clinical trial reports or detailed validation studies, which are not included in this 510(k) summary. Given the nature of a defibrillator (delivering an electric shock rather than diagnosing a complex condition), the "ground truth" for its primary function (delivering a shock when indicated) would be based on its ability to classify rhythms accurately and deliver the correct energy, which is usually assessed through engineering and electrical performance testing against established standards, rather than expert interpretation of patient data in a "test set" paradigm as one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Since the document does not describe a clinical test set with human interpretation or expert evaluation, no adjudication method is mentioned or implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic AI devices where human interpretation is involved. The Powerheart AED is a device that autonomously analyzes rhythms and advises on shock delivery, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study in the traditional sense of an AI algorithm (i.e., algorithm only without human-in-the-loop performance) was not explicitly described in terms of a separate clinical study. However, the "Performance testing" conducted to verify compliance with ANSI AAMI DF-39 would have essentially evaluated the device's (including its embedded algorithm's) ability to diagnose rhythms and deliver appropriate therapy without human intervention in terms of the core defibrillation function. The summary itself does not detail the methodology or results of this testing.

7. Type of Ground Truth Used:

The primary "ground truth" for a defibrillator typically comes from:

• Physiological/Electrical Standards: The ability to accurately detect shockable rhythms (e.g., ventricular fibrillation, ventricular tachycardia) and non-shockable rhythms, and to deliver energy within specified parameters. This is governed by industry standards like ANSI AAMI DF-39.
• Predicate Device Equivalence: The performance of a legally marketed predicate device (Agilent Technologies FR2 AED with M3870A Pediatric Attenuated Defibrillation Electrodes).

The document states that performance testing was conducted according to ANSI AAMI DF-39, implying that the "ground truth" for this testing would be based on the requirements and test methods outlined in that standard to ensure the device performs its intended functions correctly.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is expected as the Powerheart AED is not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to develop its diagnostic capabilities. Its rhythm analysis is based on pre-programmed algorithms and signal processing, not on learning from a dataset.

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

As there is no mention of a training set in the context of machine learning, there is no information on how a "ground truth for the training set" was established. The device's functionality is verified against established engineering and medical device standards.

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