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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 specific acceptance criteria and a study proving the device meets them, especially in the format of a table with reported device performance. The document is a 510(k) summary for the Powerheart ECD, and it primarily focuses on device description, indications for use, and a statement of substantial equivalence to a predicate device based on functional and safety testing.

However, I can extract the information that is present and indicate what is missing.

Here's an attempt to structure the information based on your request, along with notes on what could not be found:

Acceptance Criteria and Study for Powerheart ECD

The document K060934 for the Powerheart ECD device does not explicitly detail specific quantitative acceptance criteria or a dedicated study report proving the device meets these criteria in the requested format. Instead, it 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 is that modifications to the Powerheart ECD do not raise any new questions regarding safety or effectiveness compared to the predicate device (K052316), and it is substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "Representative samples of the device components underwent system, safety and bench testing," but the number of devices or data points used is not provided.
• Data Provenance: Not specified. The testing described is internal "system, safety and bench testing." No information on country of origin of data or whether it was retrospective or prospective is given.

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 in the 510(k) summary. The testing appears to be primarily technical/engineering verification and validation, rather than clinical studies requiring expert ground truth establishment in a medical context.

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

• This information is not provided. Given the nature of the described testing (system, safety, bench testing), formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been relevant or used.

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 MRMC comparative effectiveness study is mentioned. The device, an Automated External Defibrillator with monitoring and pacing capabilities, is not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. Its "RHYTHMx® software" provides ECG rhythm analysis, but the primary focus of the document is on the device's substantial equivalence in its overall function and safety, not on improving human reader performance with an AI component.

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

• The document implies that the device's internal software (like RHYTHMx® for ECG rhythm analysis and STAR® Biphasic waveform for energy delivery) was tested as part of the overall "system, safety and bench testing." However, a separate "standalone" study specifically on the algorithm's performance independent of the full device's operation is not explicitly mentioned or detailed.

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

• This information is not provided. For "system, safety and bench testing," the ground truth would typically be established by engineering specifications, validated test equipment, established physiological models, or comparison to known reference standards, rather than expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The sample size for the training set

• This information is not provided. The document does not describe the development or training of the RHYTHMx® software in detail. It only refers to its inclusion in the device.

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

• This information is not provided. As no training set is described, the method for establishing its ground truth is also absent.

Summary of Missing Information:

The 510(k) summary provides a high-level overview of the device and claims substantial equivalence. It does not contain the detailed quantitative data from specific studies, sample sizes for test or training sets, details about expert involvement in ground truth establishment, or specific adjudication methods that would be expected for a more in-depth performance study, particularly for an AI/algorithm-focused device. The testing described is general "system, safety and bench testing" to ensure appropriate functional and performance characteristics and to demonstrate that the changes do not raise new safety or effectiveness concerns compared to the predicate device.

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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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