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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 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 AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

The AutoPulse Resuscitation System Model 100 is an automated, portable, batterv powered device that compresses the chest of an adult human as an adjunct to manual CPR. The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. The AutoPulse Platform contains the mechanical drive mechanism, control system, software and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. The AutoPulse Platform and LifeBand are unchanged. A new battery and battery charger are the subject devices of this 510(k).

The provided documentation is a 510(k) summary for the AutoPulse® Resuscitation System Model 100, focusing on changes related to its battery and charger. It is not a study reporting on the clinical performance of the device in relation to patient outcomes or a diagnostic algorithm's accuracy.

Therefore, many of the requested fields are not applicable to this specific document as it details a submission for a modification to an already cleared device, primarily concerning electrical components, rather than a clinical effectiveness study.

Based on the provided text, here is the information that can be extracted:

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

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

• Sample Size: Not specified in terms of clinical patient data. The testing was "extensive bench testing" on the device components (new battery and charger).
• Data Provenance: Not applicable as this was bench testing, not human patient data.

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

• Number of Experts: Not applicable. Ground truth for electrical and mechanical performance is established through engineering specifications and standards, not expert clinical consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This was bench testing against engineering specifications and international standards, not a study requiring adjudication of clinical findings.

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. This document is about a mechanical resuscitation device's electrical component update, not an AI-assisted diagnostic tool.
• Effect size: Not applicable.

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

• Standalone Study: The "standalone" performance here refers to the device's functional integrity with the new battery and charger. The summary states that "the system level compatibility was verified to ensure that the AutoPulse powered with the new Li-lon battery meets the operating parameters in a safe and intended manner" and that "the new battery chemistry did not alter functioning of the AutoPulse in any way and that it operates identically to the NiMH Battery powered AutoPulse." This effectively describes the standalone performance of the modified device meeting its operational specifications.

7. The type of ground truth used

• Ground Truth: Engineering specifications for power output, charging characteristics, battery life, environmental resilience, electrical safety, and electromagnetic compatibility established by relevant international standards (e.g., IEC 60601-1, IEC 60068, CISPR11, IEC 62133).

8. The sample size for the training set

• Sample Size: Not applicable. This is not a machine learning or AI-based device requiring a training set.

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

• Ground Truth Establishment: Not applicable.

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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 miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air.

The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.

Here's an analysis of the provided text to extract the acceptance criteria and details of the supporting study:

The provided document describes a mechanical chest compressor (MCC) and its premarket notification, not an AI/algorithm-based device. Therefore, many of the requested fields related to AI performance, human-in-the-loop, training sets, and expert adjudication are not applicable or cannot be determined from the given text.

The primary study mentioned is a non-clinical animal study comparing the MCC to a predicate device.

Here's the breakdown based on the provided information, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Test Set): Not explicitly stated for either bench testing or animal testing. The animal study mentions "animal testing" but doesn't specify the number of animals.
• Data Provenance:
  • Bench Testing: Simulated cardiopulmonary resuscitation (simulated environment).
  • Animal Testing: Animal models (type of animal not specified).

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

• Not Applicable. The device is a mechanical chest compressor, not an imaging or diagnostic AI device requiring expert ground truth for a test set. The validation relies on objective physical measurements and biological outcomes in animals.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication of results is mentioned for the mechanical device performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-assisted device.

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

• Not Applicable. This is a mechanical device, not an algorithm. Bench testing evaluated its standalone mechanical performance.

7. The Type of Ground Truth Used

• For Bench Testing: "Recommended by the CPR guidelines" implies a standard for mechanical compression parameters (e.g., depth, rate) as ground truth.
• For Animal Testing: "CPR efficacy and ultimately on outcomes after prolonged cardiac arrest" suggests physiological outcomes (e.g., return of spontaneous circulation, survival metrics) were used as "ground truth" to determine effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model that requires a training set.

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

• Not Applicable. This is a mechanical device, not an AI model that requires a training set.

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LUCAS 2 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 2 must only be used in cases where chest compressions are likely to help the patient.

LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest. LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients chest via a pressure pad. The pressure pad is surrounded by a suction cup. The support legs of the upper part are fastened to the back plate prior to starting compressions.

The provided text describes the Jolife LUCAS 2, an electrically powered mechanical chest compression system. However, the document only discusses the device's design, intended use, and substantial equivalence to predicate devices, along with regulatory approval. It does not include detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device performance study, especially for AI/algorithm-based devices.

The "Testing" section broadly states that "Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices." This is a general statement and does not provide the specifics requested in your prompt.

Therefore, I cannot fully answer your request based on the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed de novo clinical or performance study report with specific acceptance criteria and detailed study methodology.

Below is a breakdown of what can be inferred or what is explicitly missing based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document mentions "a number of function tests during different operating conditions" but does not give sample sizes for any test sets or specific data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not specified. This type of information is relevant for studies involving human interpretation or expert-driven assessments, typically for diagnostic or imaging devices. The LUCAS 2 is a mechanical chest compression system, and its performance evaluation would likely involve engineering and physiological metrics, not expert ground truth in the diagnostic sense. The document does not mention any expert panel for ground truth.

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

• Not applicable/Not specified. Similar to point 3, adjudication methods are typically used for expert assessments, which are not detailed or implied for this device's testing.

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 is not relevant for a mechanical chest compression device. This type of study assesses reader performance, typically in imaging. The LUCAS 2 is a standalone mechanical device, not an AI or imaging assistance tool for human readers.

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

• Yes, effectively. The "Testing" section implies standalone testing of the device's mechanical functions: "Appropriate product testing was conducted and included a number of function tests during different operating conditions." The device itself is a standalone mechanical system. The performance evaluated would be the device's ability to deliver compressions according to guidelines, maintain consistent operation, and ensure safety, independent of human interaction during the compression delivery. The function tests described are inherently standalone performance evaluations for a mechanical device.

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

• Not explicitly stated, but implied to be engineering/physiological specifications. For a mechanical chest compression device, "ground truth" would likely refer to its ability to meet predefined physical compression parameters (depth, rate, recoil) as per AHA guidelines, safety standards, and product specifications. This would be measured instrumentally rather than through expert consensus, pathology, or outcomes data in the traditional sense used for diagnostic devices.

8. The sample size for the training set:

• Not applicable/Not specified. This device is a mechanical system, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable/Not specified. As there is no AI/ML component or "training set" mentioned, this question is not relevant.

Summary of what is known from the document regarding testing:

• Device: LUCAS 2, an electrically powered mechanical chest compression system.
• Purpose of testing: To demonstrate functionality, safety, efficacy, and capability, and to support substantial equivalence to predicate devices (LUCAS 1, Thumper 1008, Autopulse Model 100).
• Nature of testing: "A number of function tests during different operating conditions."
• Outcome: "In all instances, the LUCAS 2 functioned as intended and all results observed were as expected."
• Type of equivalence: Substantial equivalence to predicate devices is claimed, meaning the new device has "the same intended use and substantially similar indications for use, basic overall function, and performance." It is compared to predicate devices like LUCAS 1 (cleared under K062401).

The provided text focuses on regulatory clearance via the 510(k) pathway, which often relies on demonstrating equivalence rather than extensive de novo clinical trials with detailed performance metrics and acceptance criteria for a novel technology.

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