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The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.

The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles.

The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger).

The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use.

The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use.

The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits.

The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways.

The AutoPulse® NXT System comprises the subject devices included in this 510(k).

The provided document is a 510(k) premarket notification for the AutoPulse NXT Resuscitation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as an MRMC study or detailed analysis of ground truth establishment for AI models). The document primarily presents non-clinical evidence related to software verification and validation, safety testing against recognized standards, and usability testing.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially for AI/ML based devices), and ground truth establishment methods for large datasets is largely not applicable or not detailed in this document, as the device is a mechanical chest compressor and not an AI/ML diagnostic tool.

However, I can extract the information that is present and indicate where the requested details are not provided by this document:

Acceptance Criteria and Device Performance for AutoPulse NXT Resuscitation System

The provided document describes the AutoPulse NXT Resuscitation System, a mechanical chest compressor. The "acceptance criteria" in this context refer to the device's adherence to its design specifications, safety standards, and functional requirements, rather than performance metrics typically associated with AI/ML diagnostic tools (like sensitivity, specificity, or AUC). The study proving the device meets these criteria primarily involves non-clinical testing (software verification, safety standard compliance, and usability testing) rather than clinical trials with patient outcomes or large-scale data analysis for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document details a comparison of technological characteristics between the proposed device (AutoPulse NXT System) and its predicate (AutoPulse Resuscitation System Model 100). The "performance" here refers to operational parameters rather than diagnostic accuracy.

Intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective or consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). | Yes |
| Target Patient Population | Clinically dead adults as defined by a lack of spontaneous breathing and pulse. | Same | Yes |
| Min. Patient Chest Width | 9.8" | Same | Yes |
| Patient Chest Circumference | Minimum: 30", Maximum: 51.2" | Minimum: Same (30"), Maximum: 56" | Yes (Improved) |
| Maximum Patient Weight | 300 lbs. | 400 lbs. | Yes (Improved) |
| Operating Temperature | 0 – 40° C, 5 – 95% non-condensing relative humidity | 0 – 45° C, 15 – 95% non-condensing relative humidity | Yes (Improved range) |
| Compression Frequency | 80 ± 5 compressions per minute | Same | Yes |
| Compression Depth | Chest displacement equal to 20% reduction in anterior-posterior chest depth, +0.25/-0.5 inches. | Chest displacement equal to 20%, up to 2.1 +0.25/-0.5 inches reduction in anterior-posterior chest depth for each patient. | Yes (Clarified/Slightly adjusted limit) |
| Compression Modes | 30:2; 15:2; Continuous | 30:2; Continuous | Yes (Modified to 2 modes) |
| Physiologic Duty Cycle | 50 ± 5% | Same | Yes |
| Patient Basline/Depth Control | Determined and controlled via load cell. | Determined and controlled via motor current. | Yes (Different mechanism) |
| User Control Panel | One (1) LCD screen with buttons on the side. | Two (2) identical simple non-LCD user interfaces on both sides for glanceability, intuitiveness, and minimizing physical, cognitive, and visual workload. | Yes (Improved design) |
| Band change (patient position)| Patient must be off the platform. | Patient can be either on or off the platform. | Yes (Improved flexibility) |

Note: The "Acceptance Criteria Met?" column is inferred based on the FDA's clearance of the device, indicating that the differences were deemed acceptable and did not raise new questions of safety or effectiveness.

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

This document describes a medical device (mechanical chest compressor), not an AI/ML algorithm. Therefore, the concept of a "test set" in the sense of a data pipeline for AI validation does not directly apply. The "testing" involved here is primarily:

• Software Verification and Validation: Conducted internally by the manufacturer. No specific sample sizes (e.g., number of cases/patients) are mentioned as it relates to software functionality testing, not diagnostic performance on a dataset.
• Safety Testing: Compliance with international standards (e.g., ISO, IEC). This involves device testing under various conditions, not patient data sets.
• Usability Testing: Formalized human factors analyses. While a "Summative Usability Test" was conducted, the document does not specify the number of participants (sample size) or their provenance. The testing was simulated use conditions.

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

Not applicable. This device is a mechanical therapeutic device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as there isn't a "test set" as defined for AI/ML diagnostic purposes.

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

No. An MRMC study is relevant for diagnostic imaging AI. This document does not mention such a study, and it's not typically required for a mechanical chest compressor in a 510(k) submission, especially one relying on substantial equivalence to a predicate device. The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm but a mechanical device. Its performance is inherent to its mechanical and software operation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance would be its ability to mechanically deliver compressions according to its specifications and safely interact with users/patients, as verified by engineering tests, compliance with standards, and usability studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes a training phase with a dataset.

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

Not applicable. No training set is involved for this type of device.

In summary, the provided document is a regulatory submission for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, many of the questions asked, which are highly relevant to AI/ML device validation, are not applicable or detailed in this context. The "acceptance criteria" are met through adherence to design specifications, safety standards, and documented performance comparison to a predicate device, as demonstrated through engineering tests, software verification, and usability studies rather than clinical data from human subjects or AI model performance metrics.

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The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest.

The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

· Provide consistent depth and rate chest compressions.

• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.

• Be applied to the patient with minimal interruption of CPR.
  The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions.

The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module.

Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge.

A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.

The provided text describes a 510(k) premarket notification for the Defibtech RMU-2000 Automated Chest Compression System, asserting its substantial equivalence to the predicate device, the LUCAS Chest Compression System. This document focuses on demonstrating that the RMU-2000 functions safely and effectively, similar to an already cleared device. As such, it does not contain details about a study evaluating AI performance, specifically the acceptance criteria or device performance in the context of AI. The device described is a mechanical system, not an AI or software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets these criteria because the document does not pertain to an AI device.

However, I can extract the information related to the performance testing and safety/effectiveness claims made for this non-AI mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria and a direct comparison table for the RMU-2000 against pre-defined performance thresholds (as would be typical for an AI study) are not detailed. Instead, the submission relies on demonstrating substantial equivalence to a predicate device. The performance claims are primarily comparative:

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LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult Patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

LUCAS must only be used in cases where chest compressions are likely to help the patient.

The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/ consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The LUCAS Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.

The LUCAS Chest Compression System can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.

The main parts of the LUCAS Chest Compression System include:

• . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
• . An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the compression mechanism with the disposable Suction Cup.
• . A Stabilization Strap which helps to secure the position of the device in relation to the patient.
• . A Carrying Case.

In addition the following optional Accessories are offered as part of the system:

• LUCAS Battery, Dark Grey .
• . LUCAS Power Supply
• . LUCAS Car Power Cable, 12-28VDC
• . LUCAS PCI Back Plate
• o LUCAS Battery Charger
• o LUCAS Anti Slip, Slim Back Plate
• . LUCAS Trolley

The LUCAS 3 version 3.1 is the same device as the cleared LUCAS 3 device (K161768) with exception of the option to change device factory default settings according to local protocols. LUCAS 3 version 3.1 in its factory default settings has identical performance characteristics as the predicate device LUCAS 3.

The provided text describes the LUCAS 3 version 3.1 Chest Compression System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria other than general statements about software verification and validation.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the ability to configure settings like compression rate, depth, ventilation alerts, etc., but does not provide a table with specific quantitative acceptance criteria for these parameters (e.g., "Compression depth must be X mm +/- Y mm") nor does it report the device's measured performance against such criteria.

2. Sample Size for Test Set and Data Provenance:

The document states: "No new clinical testing has been performed for this version." This implies no specific test set was used to empirically demonstrate performance against new acceptance criteria for the LUCAS 3 version 3.1 itself. The assessments are "based on already available clinical data in combination with recommendations by the American Heart Association (AHA)."

Therefore, sample size for a device-specific test set and data provenance related to this version are not applicable/not provided.

3. Number of Experts and Qualifications for Ground Truth:

Since no new clinical testing was performed and the assessments are based on existing clinical data and AHA recommendations, the document does not describe the use of experts to establish ground truth for a test set specific to the LUCAS 3 version 3.1. The ground truth (AHA recommendations, existing clinical data) is implied to be established by the broader medical community and previous research.

4. Adjudication Method:

Given the lack of a specific test set requiring expert review, no adjudication method is described.

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

No MRMC study is mentioned. The device is an automatic chest compression system, not a diagnostic aid where human readers would typically be involved in interpreting results with/without AI assistance.

6. Standalone Performance:

The device is a standalone (algorithm only) device in the sense that it performs automated chest compressions. The performance data mentioned refers to "Nonclinical performance testing under simulated physiological conditions... demonstrating the reliability of delivering specific compression depth and rate over the intended duration of use." However, specific quantifiable results of this standalone performance are not provided in the document.

7. Type of Ground Truth Used:

The ground truth for the device's operational parameters is implicitly the American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines for CPR, along with "already available clinical data."

8. Sample Size for the Training Set:

The device is not an AI/machine learning model that typically has a "training set" in the conventional sense. Its "intelligence" is made up of CPUs and software following programmed logic consistent with resuscitation guidelines. Therefore, a training set sample size is not applicable.

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

As mentioned above, the concept of a training set for this device type is not applicable. The device's operational parameters are based on established medical guidelines (AHA, ERC) and existing clinical knowledge pertaining to effective CPR.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices and adherence to established medical guidelines for CPR, rather than presenting a detailed study with specific acceptance criteria and performance metrics for the LUCAS 3 version 3.1 itself. The changes in version 3.1 primarily involve software modifications to allow configuration of settings and wireless data transmission, with the claim that its factory default settings have "identical performance characteristics as the predicate device LUCAS 3." The performance testing mentioned is general verification and validation of the software and non-clinical testing under simulated conditions, but specific data is not presented.

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LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

LUCAS must only be used in cases where chest compressions are likely to help the patient.

The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The LUCAS 3 Chest Compression System is a portable tool designed to serve as an adjunct to manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association quidelines and the European Resuscitation Council quidelines.

The LUCAS chest compression system can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.

The device consists of the following components:

• . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
• An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the ● compression mechanism with the disposable Suction Cup.
• A Stabilization Strap which helps to secure the position of the device in relation to the ● patient.
• A Carrying Case. ●

In addition the following optional Accessories are offered as part of the system:

• LUCAS Battery, Dark Grey ●
• LUCAS Power Supply
• LUCAS Car Power Cable, 12-28VDC ●
• LUCAS PCI Back Plate ●
• LUCAS Battery Charger ●
• LUCAS Anti Slip, Slim Back Plate
• o LUCAS Trolley

The LUCAS 3 CHEST COMPRESSION SYSTEM captures data for post event review which may be transmitted locally using Bluetooth (transmission only available when device is powered OFF).

LUCAS 3 has substantially the same performance characteristics as the predicate device LUCAS 2.

The provided 510(k) summary for the LUCAS 3 Chest Compression System does not contain specific acceptance criteria tables nor detailed performance study results that would allow for a complete description as requested. It is a summary arguing substantial equivalence to a predicate device (LUCAS 2) based on general performance testing and compliance with various standards.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or specific precision values. Instead, it asserts compliance with various safety and performance standards.

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

The document states that "Appropriate performance testing has been conducted by both external and internal parties." However, it does not provide specific details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The type of device (mechanical chest compression system) does not typically involve expert review for diagnostic ground truth in the same way an AI diagnostic algorithm would. The "ground truth" here is compliance with technical specifications and standards for chest compression parameters (depth, rate).

4. Adjudication Method

This information is not provided. Given the nature of the device testing (compliance with technical standards and functional performance), an adjudication method like 2+1 or 3+1 (common for expert review in diagnostic studies) would likely not be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers, often with and without AI assistance, especially in image-based diagnostics. The LUCAS 3 is a mechanical device for chest compressions, not a diagnostic AI.

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

This concept is not directly applicable to the LUCAS 3 Chest Compression System as it is a mechanical device, not an AI algorithm performing a diagnostic task. The device's performance stands alone in delivering compressions, but it is operated by a human, making it implicitly "human-in-the-loop" in its application. However, the performance assessment described focuses on the device's ability to meet its technical specifications independent of human variability in manual CPR, thus in a sense its mechanical output is "standalone." The document mentions that the LUCAS 3 itself delivers compressions without explicitly comparing it to human performance in a quantitative study.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance is primarily compliance with recognized standards for medical electrical equipment, battery safety, and ambulance compatibility. Additionally, the device's functional characteristics (e.g., ability to deliver chest compressions at a certain depth and rate) would have been validated against its product specifications and the performance of the predicate device (LUCAS 2).

8. The Sample Size for the Training Set

This information is not applicable as the LUCAS 3 Chest Compression System is a mechanical device, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques.

• 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest.
• 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit.
• 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient.
• 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.

The provided text describes the ROSC-U Mini Chest Compressor (RMCC), a mechanical cardiopulmonary resuscitator, and makes claims of substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a device's performance, nor does it describe a study that explicitly proves the device meets specific performance acceptance criteria in the manner requested.

The document summarizes the device's technological characteristics and lists non-clinical performance tests. These tests are about fundamental safety and electromagnetic compatibility standards, not specific performance metrics like compression depth accuracy, rate stability, or physiological outcomes, which would typically be included in acceptance criteria for a device like this.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only mentions the following non-clinical performance tests:

It concludes that "After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor." This suggests that the studies primarily aimed to show equivalence based on safety and general functional standards rather than defined performance acceptance criteria related to its CPR efficacy.

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The CPRmeter™ is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.

This document describes the FDA 510(k) summary for the CPRmeter™ CPR Feedback Device with a Modified Cover. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (CPRmeter™ with Predicate Cover) by showing that the new Modified Cover does not raise new questions of safety or effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table for each criterion. Instead, it states that "The following tests demonstrate that the Modified Cover met applicable design and performance requirements and support a determination of substantial equivalence." and mentions general outcomes.

Implied Acceptance Criteria & Reported Performance (Based on the text):

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

The document does not specify a sample size for any test set in terms of patient data or a specific number of units tested.
The "Data Used in Determination of Substantial Equivalence" section refers to "Bench testing," "Shelf life testing," and "Biocompatibility analysis." These are likely laboratory or in-vitro tests, not clinical studies with patient data.

• Sample Size: Not specified (refers to bench testing, not human subjects).
• Data Provenance: Not explicitly stated as retrospective or prospective human data. The tests described (bench, shelf life, biocompatibility) are typically performed in a laboratory setting. The device manufacturer, Laerdal Medical AS, is based in Norway.

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

This information is not provided in the document as the tests described are bench tests and material analyses, not studies requiring expert clinical judgment for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are bench tests and material analyses, not studies involving human interpretation or adjudication.

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

No, an MRMC comparative effectiveness study was not reported. The submission focuses on substantial equivalence of a modified accessory (the cover) through bench testing, not clinical effectiveness studies comparing human reader performance.

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

The CPRmeter™ is a physical device that provides real-time feedback during CPR. Its function relies on sensors (accelerometer and force sensor) and internal processing to provide visual feedback to a human rescuer. Therefore, the concept of a "standalone algorithm" acting without human-in-the-loop performance is not directly applicable in the typical sense of AI-driven diagnostic tools.

However, the "bench testing" and "shelf life testing" could be considered as evaluating the device's intrinsic performance (its 'algorithm' for sensing and displaying data) independent of a human rescuer, under controlled, simulated conditions. The document states these tests demonstrated "acceptable performance," implying the device's sensing and feedback mechanism functions correctly.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be known physical parameters (e.g., precisely controlled compression depths, rates, and release) against which the device's reported measurements are compared. For biocompatibility, the ground truth is established by biocompatibility standards and test protocols.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The document describes a 510(k) submission for a physical device with a modified cover, not an AI/ML device that typically requires a training set. The device's functionality is based on established biomechanical principles and sensor technology, not machine learning trained on large datasets.

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

This information is not applicable/not provided as there is no mention of a training set for an AI/ML algorithm.

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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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• Defibrillation
• ECG Monitoring
• Cardioversion ●
• CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

• AED Pro
• M Series ●
• E Series ●
• R Series ●

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

• . Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians ●
• Cardiovascular Laboratory Technicians
• First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.

The provided text does not contain specific acceptance criteria for a device, nor does it describe a study detailing the device's performance against such criteria. The document is a 510(k) premarket notification for the "CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel," which is an FDA submission for substantial equivalence to legally marketed predicate devices.

Instead of acceptance criteria and device performance, the document states:

• "Substantial Equivalence - Non-Clinical Evidence:" "Safety, efficacy and substantial equivalence was shown through verification and validation testing." And earlier: "The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. ... The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742."
• "Substantial Equivalence - Clinical Evidence: N/A - Clinical evidence was not necessary to show substantial equivalence."
• "Performance Testing:" "The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document refers to "Section 18 of this submission" for performance testing details, which is not included here. The core of this FDA submission is to demonstrate equivalence to existing devices (K100565 and K110742) rather than presenting a novel study against specific, new acceptance criteria.

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The RMU-1000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport, or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR).

The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

• Provide consistent depth and rate chest compressions.
• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.
• Be applied to the patient with minimal interruption of CPR.

The major elements of the RMU-1000 ACC are the Backboard, Frame and Compression Module. The Backboard is placed under the patient to provide a base for the RMU-1000 ACC system. The Frame is placed over the patient and snaps into the Backboard with two self-locking latches, one on each side of the Frame. The Compression Module mounts into the Frame and contains the user interface, the replaceable lithium ion battery and the piston drive (and motor) used to generate the chest compressions. A replaceable, single-use Patient Interface Pad at the distal end of the Piston contacts the patient's chest and serves to soften the edges of the Piston during compressions.

Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated using a simple three-step operational sequence once the RMU-1000 ACC has been applied to a patient:

• the Compression Module is turned on by pressing the power button;
• the Piston height adjusted for the patient's chest size by pressing the appropriate height adjust button; and
• the appropriate compressions button pushed (either continuous compressions or an automatic pause for breaths).

Additional user interface features include a compression pause function button, service warning indicator, warning mute button, and battery capacity gauge.

The RMU-1000 ACC can be operated using a replaceable, rechargeable lithium-ion battery pack or with an external power supply. A fully-charged, new battery can provide continuous operation for over an hour and can be recharged while in the Compression Module.

A USB port on the Compression Module allows maintenance functions to be performed (outside of emergency use) through a connection to a personal computer.

The RMU-1000 ACC fits in a carry case that holds all the various System elements and accessories, spares (optional) and labeling.

The provided document is a 510(k) Summary for the Defibtech RMU-1000 Automated Chest Compressor (ACC) System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove device performance in a clinical sense. Therefore, many of the requested items cannot be definitively answered from this document.

Here's an attempt to extract what is available and note what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it broadly states that the device "meets functional and/or performance specifications" and "demonstrates functionally equivalent performance characteristics as the predicate device."

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

This information is not provided in the document. The document refers to "testing" and "performance evaluations" but does not specify the type of test set (e.g., patient data, simulated data), its size, or its provenance.

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

This information is not applicable and not provided. The documentation describes a medical device for automated chest compressions, not an AI or diagnostic device that requires expert-established ground truth from a test set like medical images. The "ground truth" for the performance of this device would be its ability to physically deliver compressions according to established standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, this is not an AI/diagnostic device where adjudication of expert opinions on a test set would be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

This is not applicable as the device is an Automated Chest Compressor, not an AI-assisted diagnostic tool that would involve human readers interpreting medical cases. No MRMC study was performed or mentioned.

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

This concept is somewhat applicable but presented differently for an automated mechanical device. The document explicitly states the device is "an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest." Its performance is evaluated inherently as a standalone system (when in operation) in terms of its ability to deliver consistent compressions. The performance testing mentioned ("hardware verification, software validation, design validation, and compression waveform comparison") would assess its standalone capabilities.

7. The Type of Ground Truth Used

For a mechanical device like an automated chest compressor, the "ground truth" is typically defined by established resuscitative guidelines (e.g., American Heart Association guidelines for compression depth and rate). The device's performance is measured against these objective, quantifiable standards, not against expert consensus, pathology, or outcomes data in the way a diagnostic tool would be. The document notes that "Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated."

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a mechanical device, there isn't a "training set" in the machine learning sense. The device's design and operation are based on engineering principles and medical guidelines, not data-driven machine learning models.

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

This information is not applicable. As explained above, there is no "training set" for this type of device.

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The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

The CPR RsQ Assist consists of a rigid plastic top with an integrated plastic support collar, a flexible plastic bellows filled with foam, and a removable silicone base platform. LED lights and a speaker component provide visual and audio cues, respectively, to the user during manual CPR compressions. The CPR RsQ Assist is provided non-sterile.

The provided 510(k) summary for AvanTech, Inc.'s CPR RsQ Assist describes performance data based solely on bench testing. It does not include clinical studies involving human subjects or extensive AI/algorithm-based performance assessments typically associated with the detailed criteria requested.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "bench testing" and "simulated use on conventional CPR manikin."

• Sample Size: Not specified for any of the tests. It is likely a small number of devices or test cycles typical of bench testing.
• Data Provenance: Not human data. Derived from in-house bench testing and simulated use experiments. No country of origin for data as it's not clinical. Retrospective or prospective is not applicable as it is not human data.

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

• Number of Experts: Not applicable. The ground truth for bench testing is typically derived from engineering specifications, industry standards (e.g., AHA guidelines for CPR rate/depth), and recognized test methodologies. There's no mention of human expert consensus for these physical and functional tests.
• Qualifications of Experts: Not applicable. The "ground truth" here is the expected performance based on design and standards, not expert interpretation of data.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers assess the same cases and their disagreements need to be resolved. This document describes physical, electrical, and functional bench tests where outcomes are objective measurements against defined standards.

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

• MRMC Study: No. The device is a "Cardiopulmonary Resuscitation Aid" providing real-time feedback (visual and auditory cues), not an AI-driven image analysis tool or diagnostic algorithm that would typically be evaluated in an MRMC study. There is no mention of "AI" in the document.
• Effect Size: Not applicable as no MRMC study was conducted.

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

• Standalone Performance: Not applicable in the context of typical AI algorithm evaluation. The device itself is designed to work as an assist with a human in the loop (a rescuer). Its "standalone" performance would be its ability to accurately measure and report compressions, which is what the bench tests on the manikin assessed. However, this is not an "algorithm-only" performance in the sense of a diagnostic or predictive AI.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications: For mechanical strength, structural integrity, low battery indication, and EMC/EMI.
  • Industry Standards/Guidelines: Specifically, the American Heart Association (AHA) recommended rate of 100 compressions/minute for simulated use on the manikin (chest displacement depth and rate, chest compression force).
  • ISO Standards: For biocompatibility (ISO 10993-1).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is described as a mechanical and electronic aid, not a machine learning or AI system that undergoes training with a "training set." Its functionality is based on pre-programmed logic for measurements and feedback, not learned from data.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning involved. The device functions based on established engineering principles and AHA guidelines.

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