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The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.

The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.

The Powerheart® ECD is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive TFT color display for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation, cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR® Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm thermal printer, internal storage of event history and remote synchronization to bedside monitor.

The provided text does not contain detailed information about the acceptance criteria for a specific device performance study, nor does it describe a study that explicitly proves the device meets such criteria. The document is a 510(k) summary for the Powerheart ECD, and it primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's what can be inferred regarding the functional and safety testing:

Device: Powerheart ECD™

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

The document states: "Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics."

• Acceptance Criteria (Inferred): Appropriate functional and performance characteristics for hardware and software. Given the nature of a defibrillator, this would implicitly include criteria related to:
  • ECG rhythm analysis accuracy (identifying treatable vs. non-treatable rhythms)
  • Energy delivery accuracy and safety (joule output, impedance compensation)
  • Pacing functionality (rate, capture)
  • SpO2 monitoring accuracy (if applicable)
  • Usability and user interface performance
  • Electrical safety and electromagnetic compatibility (EMC)
  • Mechanical integrity and environmental robustness.
• Reported Device Performance: The document only states that testing was performed to "demonstrate appropriate functional and performance characteristics" and that based on these results, the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate device." It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) against quantitative acceptance criteria.

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 "Representative samples of the device components" were used for testing. No specific sample sizes for particular test sets are provided, nor is information about data provenance (country, retrospective/prospective).

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)

This information is not provided in the document. The type of testing described (system, safety, bench testing) typically involves engineering and technical experts for verification, but not clinical experts establishing ground truth in the context of diagnostic accuracy studies (which are usually more relevant for AI/algorithm performance claims).

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device's "RHYTHMx® software" performs ECG rhythm analysis, but the document does not describe a study involving human readers interacting with or being assisted by this AI for diagnosis or treatment decisions.

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

The document states that the "RHYTHMx® software which provides ECG rhythm analysis" is employed. The "semi-automatic advisory mode" is described as analyzing the patient's ECG rhythm. This implies an algorithm-only (standalone) performance component for rhythm analysis. However, specific standalone performance metrics (e.g., sensitivity, specificity for treatable rhythms) are not provided in this summary. The testing mentioned ("system, safety and bench testing") would likely include assessments of this software's performance, but details are absent.

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

For the software's ECG rhythm analysis, the ground truth would typically be established by expert cardiologists reviewing ECG waveforms and clinical data. However, the document does not specify how ground truth was established for the software's performance during testing. For hardware and safety testing, ground truth often refers to engineering specifications or validated reference measurements.

8. The sample size for the training set

This information is not provided. The document describes general functional and safety testing, not a machine learning model development process with distinct training and test sets.

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

This information is not provided, as details about a training set for a machine learning model are absent.

Summary of what is present in the document:

The provided text from the 510(k) Summary focuses on demonstrating substantial equivalence of the Powerheart ECD to a predicate device (Medtronic Physio-Control LIFEPAK® 20). It broadly states that "Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics." The conclusion drawn from these tests is that the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate device," facilitating its clearance. No specific quantitative acceptance criteria or detailed results of performance studies (e.g., accuracy, sensitivity, specificity, sample sizes, expert qualifications) are included in this summary document. Such details would typically be found in the full 510(k) submission, not necessarily in the public summary.

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The Powerheart® AED G3 and the Powerheart® AED G3 Automatic devices are 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 (G3) or automatically deliver the charge (G3 Automatic).

When a patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device 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 and G3 Automatic devices are portable, battery-operated, automated external defibrillators (AED) indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices were modified to provide enhanced voice prompts.

The provided document focuses on a 510(k) premarket notification for a modification to the Powerheart® AED G3 and G3 Automatic devices, specifically for enhanced voice prompts. This type of submission generally does not require extensive clinical studies with detailed acceptance criteria and performance metrics in the same way a de novo device submission might. The document asserts "Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim," but it does not provide the specifics of that validation testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the provided text. The document primarily focuses on establishing substantial equivalence to a previously cleared device for a minor modification.

Here's a breakdown of what can be extracted and what is not available:

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

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device in intended use, materials, technological characteristics, and performance, particularly concerning the enhanced voice prompts. The document does not provide specific quantitative acceptance criteria (e.g., specific accuracy thresholds for voice prompt understanding).
• Reported Device Performance: The document states that "Validation testing relevant to the enhanced voice prompts further supports a substantial equivalence claim." However, it does not provide any specific quantitative performance metrics from this validation testing (e.g., a percentage of users correctly understanding prompts).

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

• Not Available. The document mentions "Validation testing" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

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 Available. The document does not describe the establishment of a ground truth for the enhanced voice prompts, nor does it mention any experts involved.

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

• Not Available.

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

• Not Applicable/Not Available. An MRMC study is typically used for diagnostic or image-based AI devices where human readers interpret cases. This device is an AED with enhanced voice prompts, not an AI diagnostic tool. No such study is mentioned or implied.

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

• Not Applicable/Not Available. This device is an Automated External Defibrillator (AED) that interacts with a human user. The voice prompts are inherent to the device's function, not a standalone algorithm in the sense of a standalone diagnostic tool. The performance of the voice prompts would implicitly involve a human listener.

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

• Not Available. Given the nature of "enhanced voice prompts," the "ground truth" would likely relate to the clarity, understandability, and effectiveness of the prompts in guiding user actions, which would be evaluated through user testing rather than clinical ground truths like pathology. However, no details are provided.

8. The sample size for the training set

• Not Applicable/Not Available. This document describes a modification to an existing device, not a new AI model that would require a "training set." The enhanced voice prompts are likely
  pre-recorded or synthesized speech, where the "training" would have occurred during their development, not during a separate study described in this submission.

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

• Not Applicable/Not Available. (See point 8).

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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 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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The Multifunctional Electrodes, Models 9640 and 9650 are single use and intended to be used for defibrillation, synchronized cardioversion, ECG monitoring, and external pacing.

The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out. The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference. Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Multifunctional Electrodes:

Please note that the provided document is a 510(k) summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical trials with specific acceptance criteria, statistical power calculations, or human reader studies common in AI/software device submissions. Therefore, many of the requested points below may not be fully answerable based solely on this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The performance testing is described generally as "conducted to verify that the Multifunctional Electrodes meet the applicable requirements."
• Data Provenance: Not specified. The testing described is likely laboratory-based and in-vitro, referring to the physical performance of the electrodes against engineering standards. It is not clinical data provenance.

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

This information is not applicable to the type of performance testing described. The "ground truth" for this device's performance would be the specifications and requirements outlined in the referenced ANSI/AAMI industry standards (DF-2, DF-39, EC-12), not expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication. The performance is assessed against predefined engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI

No, an MRMC comparative effectiveness study was not done, and this device is not an AI-powered diagnostic device, but rather a physical electrode. Therefore, this section is not applicable.

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

This concept is not directly applicable. The device is a physical electrode system. Its "standalone performance" refers to its ability to meet the defined electrical, mechanical, and biocompatibility standards independently, which was indeed evaluated as described in Section 16.8.

7. The Type of Ground Truth Used

The ground truth used for performance validation was industry standards and specifications. Specifically, the device's performance was compared against the requirements stipulated in:

• ANSI/AAMI DF-2 (Defibrillator Electrodes)
• ANSI/AAMI DF-39 (Automatic External Defibrillators and Associated Defibrillator Electrodes)
• ANSI/AAMI EC-12 (Disposable ECG Electrodes)
• Biocompatibility standards (implied, not explicitly named)

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrode, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.

The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest.

The provided text does not contain the detailed study information required to fill out all the requested fields for acceptance criteria and the study proving the device meets those criteria.

The submission is a 510(k) summary for the Powerheart® Cardiac Rhythm Module™ (CRM™), an Automatic External Cardioverter Defibrillator. While it describes the device's intended use and technological characteristics, it largely references compliance with standards and past clinical testing rather than presenting new study data with acceptance criteria and results.

Here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information:

• Specific numerical or statistical thresholds for performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection; energy delivery capabilities, pacing parameters).
• Actual results of the performance tests against these criteria.

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

Missing Information. The document mentions: "The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age." However, it does not provide details about:

• The sample size of this previous clinical testing.
• Whether the data was prospective or retrospective.
• The country of origin for the data.

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):

Missing Information. This level of detail is not mentioned in the provided text, as the document primarily refers to compliance with performance standards (ANSIAAMI DF2 and DF39) rather than a specific clinical validation study with expert-adjudicated ground truth.

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

Missing Information. Similar to point 3, this detail is not provided.

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:

Not applicable/Missing Information. The device described is an Automatic External Cardioverter Defibrillator (AED) and a pacing device. While it uses "FDA-cleared and patented arrhythmia detection software," it's not a diagnostic aid where human readers or their improvement with AI assistance would typically be measured. The device automatically detects and delivers therapy or advises the operator to shock, or is used in manual mode. Therefore, an MRMC study related to human reader improvement with AI assistance is not described or relevant for this type of device based on the provided text.

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

Partially Addressed / Implied.

• The "Fully Automatic Mode" implies standalone algorithm performance as it "automatically provides defibrillation therapy."
• The document states: "The Powerheart CRM utilizes an FDA-cleared and patented arrhythmia detection software that continuously monitors, detects and delivers therapy..."
• The performance tests follow "applicable portions of the ANSIAAMI DF2 and DF39 requirements," which would include testing the device's automated detection and therapy delivery algorithms. However, a specific "standalone study" with detailed results (like sensitivity/specificity for arrhythmia detection) is not presented.

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

Missing Information. For the "previously undergone clinical testing," the method for establishing ground truth is not specified. For the performance tests against ANSIAAMI standards, these standards typically involve specific test signals and simulated conditions, which serve as the "ground truth" for evaluating the device's response.

8. The sample size for the training set:

Missing Information. The document mentions "FDA-cleared and patented arrhythmia detection software," which indicates development and likely a training phase. However, no details about the training set size are provided.

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

Missing Information. No information is given regarding the training set or its ground truth establishment.

In summary: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant standards (ANSIAAMI DF2 and DF39). It explicitly states that performance tests were conducted and will be subjected to pre-determined pass criteria, but it does not present the detailed results, acceptance criteria, or study methodologies (like sample sizes, ground truth establishment, or expert involvement) that would be found in a comprehensive clinical or performance study report.

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The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific pass/fail acceptance criteria values (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it confirms that the device was deemed "as safe based on the non-chilical performance tosting, and the predicate device." This suggests a comparative approach where the performance of the new device was evaluated against the established performance of the predicate device (Powerheart® AECD® cleared under K970741).

The study lists a series of non-clinical tests performed, implying that successful completion of these tests serves as the "acceptance criteria" for demonstrating safety and effectiveness comparable to the predicate.

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

The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only lists categories of non-clinical tests.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test set. Given the non-clinical nature of the listed tests, it's possible that internal engineering and validation teams were involved rather than external clinical experts for the direct evaluation of the device's
arrhythmia detection software.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1).

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device itself and its comparison to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance evaluation of the "Arrhythmia Detection Software" was performed, as indicated by "Arrhythmia Detection Software Verification and Validation" under non-clinical tests. The document implies that the software's performance (specifically its detection capabilities) was deemed equivalent to the predicate device's software.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For arrhythmia detection software validation, it would typically involve a reference standard derived from expert-annotated ECG recordings, often from established arrhythmia databases.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

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The AECD Arrhythmia Detection Software, when loaded into the Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the "arrhythmia detector" software program which is the primary component of the unmodified Powerheart AECD (K970741).

This is a computer software program which analyzes the patient's ECG waveform and determines whether the patient exhibits a non-shockable rhythm, based upon the physician programmed parameters for the patient.

This software is not a standalone medical software device. The AECD Arrhythmia Detection Software will be marketed as a component intended to enhance the performance of defibrillators and/or patient monitors by adding this functionality to those products.

This document describes the AECD® Arrhythmia Detection Software®, solely referring to the software component of a previously cleared device, the Powerheart® AECD®.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a specific table for the performance of the AECD Arrhythmia Detection Software as a standalone submission. Instead, it refers to the performance of the Powerheart AECD (K970741), of which this software is a component.

Therefore, the table below reflects what can be inferred about the software's performance from the context of its predicate device, as directly stated performance metrics for the software alone are not provided in this specific submission.

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

The document refers to "bench testing using standard ECG databases" and "clinical data resulting from IDE Application G920078" from the predicate device (Powerheart AECD, K970741).

• Sample Size for Test Set: Not specified in this document. It mentions "standard ECG databases" for bench testing and "clinical data" from an IDE. To find the exact sample size, the predicate device's (K970741) submission would need to be reviewed.
• Data Provenance:
  • Bench Testing: Standard ECG databases (specific origin not detailed in this document).
  • Clinical Data: From IDE Application G920078 (no country of origin or retrospective/prospective nature specified in this document, but IDEs are typically prospective clinical trials).

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

Not specified in this document. The document only mentions "standard ECG databases" and "clinical data," but provides no details on how ground truth was established for these datasets, nor the number or qualifications of experts involved.

4. Adjudication Method for the Test Set:

Not specified in this document.

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

No, an MRMC comparative effectiveness study is not mentioned in this document. The device is a "computer software program which analyzes the patient's ECG waveform," implying an automated detection system, not one that assists human readers.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance evaluation of the algorithm was done. The document explicitly states: "Bench testing was performed using standard ECG databases prior to the clinical trials. Testing demonstrated that the software performs according to its specifications." This refers to the algorithm's performance without human interaction.

7. Type of Ground Truth Used:

Based on the description of the device's function (detecting ventricular tachyarrhythmias and non-shockable rhythms) and the use of "standard ECG databases" and "clinical data," the ground truth likely involved:

• Expert Consensus/Diagnosis: For clinical data, this would involve diagnoses made by cardiologists or electrophysiologists.
• Reference Annotations: For standard ECG databases, these often contain expert-annotated rhythm labels, which serve as ground truth for algorithm training and testing.

8. Sample Size for the Training Set:

Not specified in this document. The document refers to "standard ECG databases" which are often used for both training and testing, but separates them as "bench testing prior to clinical trials." The size of any training set used for the software's development is not detailed.

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

Not specified in this document. As with the test set, it can be inferred that expert annotations or diagnoses, typical for ECG databases, would have been used.

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The Powerheart® Automatic External Cardioverter Defibrillator (AECD)® system is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tacharrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Powerheart Automatic External Cardioverter Defibrillator monitors a patient's cardiac electrical activity and treats ventricular tacharrhythmias. The Powerheart senses the ECG signal using one set of electrodes, and delivers cardioversion and/or defibrillation energy through another set of electrodes. The cardioversion/defibrillation electrodes are positioned on the patient either transchest or anterior-posteriorly . The Powerheart uses a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias.

When a shockable arrhythmia is detected, the system selects the appropriate (i.e., as pre-set by the patient's physician) electrical countershock for delivery attempt restoring normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will proceed with subsequent delivery of energy (as pre-set by the patient's physician) after each additional evaluation and charging period. Depending upon the physician programmed parameters, the Powerheart may deliver a maximum of eight pulse sequences. Then, the Powerheart will deliver no further therapy automatically until 60 seconds of consecutive non-shockable rhythm is presented or the device is reset manually.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® Automatic External Cardioverter Defibrillator (AECD®):

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance in terms of specific metrics like sensitivity, specificity, or positive/negative predictive values for arrhythmia detection or treatment success rates. Instead, it refers to conformance with applicable voluntary standards and that the device "performs according to its specifications."

The closest the document comes to defining "acceptance criteria" for performance is:

• "The Powerheart AECD was mechanically and functionally tested to demonstrate conformance with applicable section of the ANSI/AAMI voluntary standard DF39-1993 for Automatic External Defibrillators and Remote Control Defibrillators, the ANSI/AAMI Standard ES1-1993, Safe Current Limits for Electromedical Apparatus, and UL544."
• "The testing demonstrated that the device performs according to its specifications."
• "Data from a clinical investigation of the Powerheart AECD demonstrated that the device is able to safely and effectively treat ventricular tacharrhythmias according to the device specifications."

Since specific numerical acceptance criteria (e.g., "sensitivity must be >XX%") are not provided, I cannot create a table with reported device performance against such criteria. The "reported performance" is broad conformance and ability to safely and effectively treat.

Study Details:

Given the lack of specific detail in the provided text, many fields below will be marked as "Not Provided."

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

  Acceptance Criteria (Stated or Implied)	Reported Device Performance
  Conformance with ANSI/AAMI DF39-1993 (AEDs)	Device performs according to its specifications.
  Conformance with ANSI/AAMI ES1-1993 (Safe Current Limits)	Device performs according to its specifications.
  Conformance with UL544	Device performs according to its specifications.
  Software performs according to specifications (per FDA Reviewer Guidance for CCD)	Software performs according to its specifications.
  Able to safely and effectively treat ventricular tachyarrhythmias (clinical investigation)	Device is able to safely and effectively treat ventricular tachyarrhythmias according to device specifications.

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

  • Sample Size (Test Set): Not Provided. The document mentions "Data from a clinical investigation" but gives no details on the number of patients or cases.
  • Data Provenance:
    • Country of Origin: Not Provided.
    • Retrospective/Prospective: Not Provided. It's described as a "clinical investigation," which typically implies prospective data collection, but this is not explicitly stated.

• 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 Provided. The document mentions "clinical investigation" but offers no details on ground truth establishment methods or expert involvement.

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

  • Not Provided.

• 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

  • Not Applicable/Not Provided. This device is an Automatic External Cardioverter Defibrillator (AECD), meaning it's primarily an automated device for arrhythmia detection and treatment, not an AI-assisted diagnostic tool for human readers in the typical MRMC study context. The "clinical investigation" would be assessing the device's direct performance, not how it improves human interpretation.

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

  • Yes, implicitly. The device is described as "Automatic External Cardioverter Defibrillator," which functions in a standalone manner to detect and treat arrhythmias. The "clinical investigation" assessed the device's ability to "safely and effectively treat ventricular tacharrhythmias," implying standalone performance evaluation.

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

  • Not Explicitly Provided. For a defibrillator, the "ground truth" for successful treatment of ventricular tachyarrhythmias would likely be rhythm conversion to a non-shockable rhythm, as assessed by ECG monitoring and patient status. However, the exact methods or criteria are not detailed in the summary. It would fall under "outcomes data" related to rhythm status.

• 8. The sample size for the training set

  • Not Applicable/Not Provided. The term "training set" is typically used for machine learning models. While the device uses "a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias," it's not described as a deep learning or AI model that would require a distinct "training set" in the modern sense. It likely uses rule-based algorithms or traditional signal processing. The "software" was developed and tested to its specifications, but no mention of a traditional machine learning training set.

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

  • Not Applicable/Not Provided (see answer to #8).

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