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The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.

An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.

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

The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs).

The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.

The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.

The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Defibrillation pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a rescue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.

The Powerheart® G5 CPR Device (CPRD), used in conjunction with the G5 AED, is a single use tool that provides CPR performance feedback to aid a CPR trained rescuer in the performance of CPR. The CPRD provides compression rate and depth audio feedback. CPR measurements are recorded for post-event review.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powerheart G5 AED with optional CPR device:

Acceptance Criteria and Device Performance for Powerheart G5 AED with CPR Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set used in the functional, software, hardware, or human factors studies.

• Test Set Description:
  • Functional/Software/Hardware Testing: No specific number of test cases or data points is mentioned. The description suggests comprehensive testing (white box, black box, unit, integration).
  • Human Factors: "Each participant" implies a finite number of individuals, but the exact count is not provided.
• Data Provenance: Not specified. The studies appear to be internal company evaluations, so the data would be proprietary/internal. No mention of country of origin or whether it's retrospective or prospective is made.

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

The document does not describe the use of external experts for establishing ground truth within the context of these engineering and human factors tests. The ground truth for functional, software, and hardware performance would typically be established based on engineering specifications, industry standards, and internal quality assurance protocols. For human factors, the success criteria (e.g., proper application, no delay/distraction) would have been predefined by the study designers.

4. Adjudication Method for the Test Set

No adjudication method is described, as the studies are primarily technical performance and human factors evaluations rather than diagnostic accuracy studies requiring multiple expert interpretations.

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

No MRMC comparative effectiveness study is mentioned. The evaluation focuses on the safety and effectiveness of the device itself and its substantial equivalence to predicate devices, not on the improvement of human readers' performance with AI assistance.

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

The device, an Automated External Defibrillator (AED), inherently operates with significant automated functions (ECG analysis, shock advisory/delivery). The studies described are implicitly evaluating the standalone performance of these automated functions (software and hardware evaluation). The human factors test evaluates the interaction with the human user, not the delegation of diagnostic tasks from a human to the algorithm, or the improvement of the human's diagnostic ability. Therefore, yes, standalone (algorithm-only) performance was assessed for the core AED functionality.

7. Type of Ground Truth Used

• Functional/Software/Hardware: The ground truth for these tests is based on engineering specifications, design requirements, and industry standards (e.g., for defibrillation accuracy, timing, CPR feedback parameters). Tests aim to verify that the device's output matches these predefined correct behaviors.
• Human Factors: The ground truth for the human factors study would be pre-defined success criteria for proper device usage and the absence of factors delaying or distracting rescuer performance.

8. Sample Size for the Training Set

No information about a training set for an AI/machine learning model is provided. This device is an AED with CPR feedback, and the description of its software evaluation does not indicate the use of machine learning that would require a distinct "training set" in the context of predictive algorithms. The software validation is traditional verification and validation against requirements and design.

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

As no training set is mentioned in the context of machine learning, this question is not applicable based on the provided document.

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The GS Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.

An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.

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

The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary.

The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED.

The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Adult pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a resoue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.

The provided text describes the Powerheart® G5 AED and its intended use, but it does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria related to its diagnostic or therapeutic efficacy. The document is a 510(k) summary for premarket notification, focusing on demonstrating substantial equivalence to a predicate device.

The "Functional Tests" section (F) merely states: "The Powerheart® G5 AED was subjected to performance hardware and software evaluations in accordance with industry standards. The G5 passed all software and hardware tests and was found to perform as intended." This is a very general statement and does not provide specific acceptance criteria or study results.

Therefore, I cannot provide the requested information from the given text. The text does not detail:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or their acceptance thresholds are mentioned.
2. Sample size used for the test set and the data provenance: No test data or information about the test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment is given.
4. Adjudication method for the test set: Not applicable as no test set details are provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone performance study was done: No standalone performance study details are provided.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: No information on training data is provided.
9. How the ground truth for the training set was established: Not specified.

This document focuses on demonstrating that the Powerheart® G5 AED is substantially equivalent to the Powerheart® AED G3 based on indications for use, technological characteristics, materials, and a conceptual "software algorithm," but it does not delve into the detailed performance evaluation against specific clinical or technical acceptance criteria.

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The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

The mySense™ Heart, developed by Cardiac Science Corporation (CSC), is small, lightweight, patch-style cardiac monitor, designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 24 hours. The device system is composed of 2 main components:

• . Recorder - The mySense Heart recorder is about the size of a large band-aid and contains 2 electrodes that are used for sensing and detecting a patient's ECG. The recorder has an adhesive pad so that it can be attached to the patient's skin in the chest region for ECG collection.
• Recorder Processing Software (RPS) The RPS is installed on a . computer where the patient's ECG data on the recorder will be downloaded for subsequent analysis by ECG technicians/clinicians.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally states that "All testing demonstrated acceptable results." The primary method for demonstrating "acceptability" appears to be equivalence to a predicate device.

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

• Sample Size for Test Set: 50 cardiac subjects.
• Data Provenance: The document does not explicitly state the country of origin. It describes it as a "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects." This suggests a prospective clinical study setup.

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

The document does not provide this information. It mentions "subsequent analysis by ECG technicians/clinicians" for the downloaded data, but it doesn't specify how ground truth for comparative testing was established (e.g., number of expert cardiologists interpreting the predicate device's data to serve as truth).

4. Adjudication Method for the Test Set:

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size Improvements:

The document describes "Clinical trial Comparative testing against a commercially available Holter ECG monitor (predicate device) in 50 cardiac subjects," but this appears to compare the device's performance to a predicate device, not the human reader's performance with and without AI assistance. Therefore, an MRMC study related to AI assistance was not done, and no effect size for human reader improvement is stated. This device is a data acquisition device, not an AI-powered diagnostic tool in the sense of image interpretation.

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

The device is a recorder that collects ECG data. The "Recorder Processing Software (RPS)" is mentioned for "subsequent analysis by ECG technicians/clinicians." This implies that the device's primary function is data acquisition, and human review is part of the intended workflow. The "testing" section focuses on the device's ability to accurately record data and its adherence to various safety and design standards. While the RPS might have some automated processing, the core "performance" being evaluated seems to be the recording capability and equivalence to a Holter. Therefore, a standalone diagnostic algorithm performance study in the absence of human review does not appear to be the focus or explicitly detailed here.

7. The Type of Ground Truth Used:

The ground truth for the clinical comparative testing is implicitly the ECG data recorded by the predicate Holter monitor, which is considered the "gold standard" for ambulatory ECG recording in this context. The study compares the mySense™ Heart's recorded data to this established truth.

8. The Sample Size for the Training Set:

This information is not provided in the document. The device is a hardware recorder with associated software for processing, not a machine learning model that requires a "training set" in the conventional sense for deep learning. If there are internal algorithms within the RPS for artifact detection or basic rhythm classification, the training of such might not be detailed here.

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

As no explicit "training set" and associated machine learning model development are described, this information is not applicable/provided.

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The Powerheart® AED G3 family of devices 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).

When the 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.

Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:

At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with 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 G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart® AED G3 Automatic, the AED automatically delivers a shock if needed. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed.

The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.

The provided text describes a 510(k) premarket notification for a software modification to existing Powerheart® AED G3 devices. The core of this submission is about enhancing the detection capability of the device's self-test feature, not about a new clinical algorithm for patient diagnosis or treatment. This type of submission typically focuses on functional and performance testing related to the software change rather than a comprehensive clinical study to prove efficacy in an AI context.

Therefore, many of the requested elements for an AI/device performance study (like MRMC studies, sample sizes for training/test sets, expert qualifications, etc.) are not applicable or not provided in this document as it pertains to a software change for a self-test feature in an AED. The document essentially states that the new software has been verified and validated to ensure continued safety and effectiveness, and that it is substantially equivalent to the previously cleared predicate devices.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific metrics for the software modification. Instead, it concludes that "software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."

The implicit acceptance criterion for this 510(k) submission is that the modified software maintains the safety and effectiveness of the device and does not raise new questions of safety or effectiveness compared to the predicate device. The "reported device performance" is summarized as "appropriate functional and performance characteristics" being demonstrated.

Given that this is a 510(k) for a software enhancement to a self-test feature, quantitative clinical performance metrics (like sensitivity, specificity for detecting cardiac events) are not the focus of this particular submission. The focus is on the self-test's capability to detect issues.

Study Details

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

   • Acceptance Criteria: Implicitly, the software modification must maintain the safety and effectiveness of the device, as demonstrated through successful verification and validation testing, and ensure no new questions of safety or effectiveness are raised compared to the predicate device.
   • Reported Device Performance: "Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."

2. Sample sizes used for the test set and the data provenance:

   • Not explicitly stated in the provided text. The document mentions "software verification and validation testing" but does not detail the specific test cases, sample sizes, or the origin of any data used for these tests. For a self-test software change, this would likely involve internal testing data rather than patient data from specific countries.

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

   • Not applicable/Not stated. This submission focuses on a software modification for a self-test mechanism, not on a diagnostic algorithm requiring expert-established ground truth from medical images or physiological signals.

4. Adjudication method for the test set:

   • Not applicable/Not stated. As above, no clinical diagnostic "ground truth" relevant to human adjudication appears to be established for this software modification.

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, an MRMC study was not done or reported. This type of study is relevant for AI-powered diagnostic or assistive tools where human performance can be measured and compared with and without AI assistance. This submission describes a modification to a device's self-test feature, which does not involve human readers in an diagnostic capacity in conjunction with an AI.

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

   • Yes (inferred), in the context of the self-test. The core of this submission is a "software modification to enhance the detection capability of the device self-test feature." This implies that the algorithm for the self-test itself operates in a standalone manner to identify potential device malfunctions. The performance of this specific software component would have been evaluated directly. Details on this evaluation are not available beyond the statement of successful completion.

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

   • Not explicitly stated. For a self-test feature, the "ground truth" would likely be derived from engineering specifications and known failure modes, simulated faulty conditions, or controlled test environments designed to verify the self-test's ability to detect predetermined internal issues. It is not a clinical ground truth like pathology or expert consensus on patient diagnosis.

8. The sample size for the training set:

   • Not applicable/Not stated. This submission describes a software modification to an existing device's self-test, not the development of a new AI algorithm that typically requires a large training set from medical data. If any "training" occurred, it would be in the context of software development and debugging, using internal data or simulated environments, rather than a clinical training set.

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

   • Not applicable/Not stated. See point 8.

Summary of Device and Submission Type:
The Powerheart® AED G3 devices are Automated External Defibrillators. This 510(k) submission (K102496) is for a software modification to enhance the detection capability of the device's self-test feature. This is a crucial distinction, as it is not a submission for a new AI diagnostic algorithm or an AI-assisted diagnostic tool for which many of the requested performance metrics would be relevant. The submission primarily asserts substantial equivalence to previously cleared predicate devices based on successful software verification and validation testing, confirming the modified software maintains appropriate functional and performance characteristics and doesn't raise new safety/effectiveness concerns.

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The Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting ECG testing. In addition, the CareCenter MD provides interfaces for acquiring physiological data from ancillary devices (such as spirometry and blood pressure) and records ECG in real time with and without arrhythmia detection.

The system provides automatic interpretation of resting ECG on adult populations. No automatic interpretation of resting ECGs is provided for pediatric populations. Interpretive statements should be overviewed and approved by trained physicians.

The CareCenter MD may provide interfaces for the control of external devices such as a treadmill or an ergometer, and for communicating with centralized computer systems via a network. The device is intended to provide non-diagnostic patient data management functions as both a selfcontained, stand-alone application and by interfacing with Electronic Medical Records systems.

The device is not intended to be used as a vital signs or long term physiological monitor. The CareCenter MD is not intended to be used as a transport device.

The Cardiac Science CareCenter MD is a medical device system comprised of software and hardware acquisition modules used for acquisition, evaluation and administration of 12-channel electrocardiograph (ECG) from patients both at rest and during exercise (stress testing). The Cardiac Science CareCenter MD software is installed on a customer provided personal computer (PC).

CareCenter MD is a diagnostic device capable of ECG monitoring; ST analysis and arrhythmia detection; generation, review, and storage of stress reports; interpretation of resting ECG reports; and treadmill or ergometer control. Approved serial devices such as non-invasive blood pressure measurement are supported by CareCenter MD for stress testing.

The provided text for the CareCenter MD (Electrocardiograph) does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics.

Instead, the document primarily focuses on establishing substantial equivalence to predicate devices based on shared technological characteristics and intended use. It confirms that "Device components underwent safety and bench testing on both hardware and software and demonstrated acceptable functional and performance results," but it does not elaborate on what those "acceptable functional and performance results" were or how they were measured against specific criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance from the provided text. Similarly, I cannot provide details about sample sizes, data provenance, ground truth establishment, or study types (MRMC, standalone) because such information is not present in the given document.

The document mainly serves as a 510(k) summary for an electrocardiograph, emphasizing its similarity to existing devices for regulatory approval, rather than detailing a specific performance study with quantitative results against acceptance criteria.

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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 physicianauthorized emergency medical response.

The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Postresuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of 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 the 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 are portable, battery operated, automated external defibrillators (AED). After applying the AED's electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and advises the operator to press the button and deliver a shock if needed. The AED uses one button and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart AED G3 Automatic, the AED automatically delivers a shock if needed. The Cardiac Science G3 AEDs may be used in conjunction with an adaptor cable that allows the use of AAMI DF-80 compliant electrodes other than the Cardiac Science brand. This adaptor cable is provided as an accessory to the Cardiac Science AEDs.

1. Acceptance Criteria and Reported Device Performance

The provided document describes a Special 510(k) for modifications to the Powerheart AED G3 and G3 Automatic devices. The acceptance criteria and device performance are primarily evaluated through functional and safety testing to ensure equivalence with predicate devices.

2. Sample Size and Data Provenance

The document states that "Representative samples of the device and adapter cables were tested." However, it does not specify the exact sample size used for the functional and safety testing. The data provenance is derived from internal testing conducted by Cardiac Science Corporation in Bothell, WA. The study is prospective in the sense that the new device and adapter cables were subjected to testing.

3. Number and Qualifications of Experts for Ground Truth

Based on the provided document, there is no mention of external experts or a panel used to establish ground truth for a test set. The evaluation relies on the device meeting pre-defined functional and safety specifications.

4. Adjudication Method

Since there is no mention of a test set requiring expert interpretation or a ground truth established by experts, there is no adjudication method described in the document.

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

An MRMC comparative effectiveness study was not conducted as described in the provided document. The focus of this 510(k) is on demonstrating substantial equivalence of a modified device and accessory through functional and safety testing rather than evaluating reader performance.

6. Standalone (Algorithm Only) Performance Study

The document describes testing of the device and adapter cables as a complete system, including its automatic analysis of ECG and delivery/advising of shock. Therefore, a standalone performance of the algorithm without human-in-the-loop is inherent to its functionality. However, it does not explicitly present a separate "algorithm only" performance study distinct from the overall system's functional testing. The device itself is an automated external defibrillator, meaning its core function is algorithmic analysis and action.

7. Type of Ground Truth Used for Test Set

The "ground truth" for the test set (functional and safety testing) is based on pre-established system, safety, functional, and performance specifications. The device's ability to operate according to these engineering and regulatory standards serves as the ground truth. This is not clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical diagnoses).

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI model training in the context of this 510(k) submission. Therefore, no sample size for a training set is provided. The device likely uses established algorithms for ECG analysis that predate this specific submission.

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

Since a training set is not mentioned, the method for establishing its ground truth is not applicable based on the provided information.

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Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.

Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.

The electrodes are intended for short term use (

The model 9131 and the 9133 Defibrillation Electrodes consists of a pair (2 each) of hydrogel polymeric self adhesive electrode pads of equal dimension. The outer dimension for each pad is 4.88in (12.4cm) by 4.88in (12.4 cm). Each electrode pad has a conductive hydrogel polymeric area of at least 50cm2 to comply with the AAMI DF-80 (AAMI DF-39) specifications. The total surface area of the two electrodes is greater or equal to 150cm2.

The electrodes pads are packaged in such a way that the two conductive hydrogel surfaces are in electrical contact. This feature enables the Cardiac Science AED to run diagnostic checks on the electrodes by checking the inter-electrode impedance when the electrode package is connected to and stored in the device.

The Cardiac Science 9133 defibrillation electrodes may be used in conjunction with adaptor cables that allow the electrodes to be used with compliant AEDs other than the Cardiac Science brands. These adaptor cables are provided as accessories to the Cardiac Science defibrillation electrodes.

The provided document is limited in the information it provides regarding acceptance criteria and study details. It refers to a 510(k) summary for defibrillation electrodes, focusing on substantial equivalence to a predicate device rather than a comprehensive de novo validation study with specific acceptance criteria and detailed performance metrics of an AI component.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states, "Representative samples of the electrodes were tested." It does not specify the exact number of samples used in the "Functional and Safety Testing."
• Data Provenance: Not specified. This document is a 510(k) summary, which typically reports on internal testing or testing required for regulatory submission. It does not provide details on the origin of the data beyond "representative samples." It is likely internal testing data.
• Retrospective/Prospective: Not specified.

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

• Not Applicable. The device (defibrillation electrodes) is a hardware component and accessory. Its "performance" is assessed through functional, electrical, and safety testing against engineering and regulatory standards (e.g., AAMI DF-80). It does not involve human interpretation of outputs that would require expert-established ground truth in the context of, for example, medical image analysis or diagnostic algorithms.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this is a hardware device. No adjudication method for expert consensus is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This document describes a 510(k) submission for defibrillation electrodes, which are passive medical devices. MRMC studies are typically performed for diagnostic devices (especially those involving AI or human interpretation) to assess improvements in human reader performance with computational assistance. This is not relevant here.

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

• No. This device is hardware. It does not have an "algorithm only" component in the sense of AI. Its function is to deliver electrical energy and monitor. The "testing" referred to is about its physical and electrical properties.

7. The Type of Ground Truth Used

• Engineering and Regulatory Standards/Specifications. The "ground truth" for the device's performance is established by compliance with recognized industry standards (e.g., AAMI DF-80 (AAMI DF-39) specifications) and the device's own internal functional and safety specifications. For instance, impedance, adhesion, and energy delivery capabilities would be measured against predefined acceptable ranges derived from these standards.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an AI/machine learning algorithm for this type of hardware device.

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

• Not Applicable. No training set is involved.

Summary of Device and Study Type:

This 510(k) summary is for physical defibrillation electrodes. The "study" described is a series of functional and safety tests to demonstrate that the new models (9131 and 9133) meet established performance specifications and are substantially equivalent to a previously cleared predicate device (Survivalink-9130 Defibrillation Electrode, K971149). It is not a clinical efficacy study involving patient outcomes or a diagnostic AI validation study. The acceptance criteria are based on engineering and regulatory standards for defibrillation electrodes.

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The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis and ventricular ectopic beat detection; generation, review, and storage of stress reports; and treadmill or ergometer control. These devices consist of a patient cable, preamplifier, PC, display, mouse, printer, keyboard, and isolation power supply. Approved serial devices such as non-invasive blood pressure measurement may be supported by these devices. Electrocardiographic data is obtained by the preamplifier and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.

The provided text is a 510(k) summary for the Cardiac Science Corporation's Q-Stress and HeartStride devices. It describes the devices, their intended use, and their substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.

The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device (K001492, Q-Stress). In such submissions, extensive clinical studies with detailed performance metrics are often not required if the new device shares the same intended use, technological characteristics, and fundamental principles of operation as a legally marketed predicate device. The FDA typically relies on the established safety and effectiveness of the predicate.

Therefore, I cannot provide the requested information based on the input text. The table and other details you asked for are not present in this 510(k) summary.

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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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Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.

This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.

The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem.

The differences between the Atria 3100 and 6100 are as follows:

1. Screen Size:
   Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
   Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
2. Storage:
   . Atria 3100 = 50 records
   Atria 6100 = 150 records .
3. The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.

Here's an analysis of the provided information regarding the Atria 3100 and Atria 6100 electrocardiographs, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It primarily describes the device, its intended use, and argues for substantial equivalence to predicate devices. It does NOT contain detailed information on specific acceptance criteria or the studies that would typically prove a device meets those criteria in a rigorous fashion (e.g., performance metrics, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance).

Therefore, I will extract relevant information where available and explicitly state when information is not present in the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Its clearance is based on substantial equivalence to predicate devices. This means the FDA determined the new device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.

The document states the "intended use, indication for use and principle of operation are substantially equivalent to the predicate devices, and do not raise any new types of safety and effectiveness questions." This is the core "acceptance criteria" from a regulatory perspective for a 510(k) submission, rather than specific performance numbers.

Predicate Devices:

• PageWriter Trim Series Cardiograph - Phillips Medical Systems (K031422)
• CP 100 and CP 200 - Welch Allyn, Inc. (K050074)

Detailed Study Information (Based on Available Text)

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

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided text. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to existing predicate devices regarding safety and effectiveness, and not raising new safety/effectiveness questions.
   • Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity for ECG interpretation) are reported in this document. The device "can display, print, electronically send and save ECG recordings" and "provides an optional interpretation." The document repeatedly states it's "not designed to produce a definitive interpretation nor exhaustive evaluation" but rather "provide an effective beginning for evaluation."

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

   • Not provided in the document. The 510(k) summary focuses on device description and substantial equivalence, not detailed clinical study results.

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 in the document. No information on ground truth establishment for any test set (since no test set is described).

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

   • Not provided in the document. No information on adjudication methods.

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 provided in the document. This type of study is not mentioned as part of the 510(k) submission, likely because the primary claim is not about improved human performance with AI assistance, but rather the device's basic functionality and equivalence. The "optional interpretation" is mentioned, but its performance or impact on human readers is not detailed.

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

   • Not provided in the document. While the device offers "optional interpretation," the document specifically states it's "not designed to produce a definitive interpretation nor exhaustive evaluation." This implies that a standalone, definitive diagnostic performance study was likely not part of this 510(k) given its intended use as an initial evaluation tool.

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

   • Not provided in the document. No information on ground truth, as no specific performance study is detailed.

8. The sample size for the training set

   • Not provided in the document. No information on any training set, as the document doesn't detail the development or validation of the "optional interpretation" algorithm.

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

   • Not provided in the document.

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