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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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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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LUCAS® External Cardiac Compressor 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 manual chest compression would be used.

LUCAS® is only intended for temporary use.

LUCAS® is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.

LUCAS® consists of an upper part containing a pneumatically driven piston rod, which acts on the patients chest via a pressure pad integrated into the suction cup.

The support legs of the upper part are fastened to the back plate prior to starting compressions.

LUCAS® is powered by compressed air from a wall outlet in a hospital or an ambulance, or from a cylinder.

The provided text describes the 510(k) summary for Jolife's Modified LUCAS® external cardiac compressor. It does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the format requested.

The document is a regulatory submission for premarket notification (510(k)) to demonstrate substantial equivalence to predicate devices, not a clinical study report with detailed performance metrics against acceptance criteria.

Based on the provided text, the requested information cannot be fully extracted as it is not present.

Here's a breakdown of what can be inferred or stated about the requested points, and what is explicitly missing:

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

• Missing from the text. The document states that the device provides compressions "according to the guidelines given by the American Heart Association (AHA)," but it does not specify quantitative acceptance criteria (e.g., minimum compression depth, rate, or recoil) or report specific device performance metrics against such criteria.

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

• Missing from the text. No information on a test set sample size or data provenance is provided. The document mentions "Appropriate product testing was conducted and included a number of function tests during different operating conditions," but these appear to be engineering/functional tests rather than clinical or performance studies with a "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing from the text. No information about experts establishing ground truth for a test set is provided.

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

• Missing from the text. No adjudication method for a test set is mentioned.

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

• Missing from the text. This device is a mechanical chest compressor, not an AI-assisted diagnostic tool for human "readers." Therefore, an MRMC study related to human interpretation with/without AI assistance would not be applicable to this product.

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

• Partially addressed/Inferred: The device is a standalone mechanical compressor. Its performance is described as "consistent and uninterrupted compressions according to the guidelines given by the American Heart Association (AHA)" and it allows for "hands-free compressions." The testing section (Section 6) states, "These tests demonstrated that the functionality, safety and capability of LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected." This indicates standalone functional testing was performed, but no specific performance metrics are reported.

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

• Inferred/Contextual: The "ground truth" for this device, which performs chest compressions, would be its ability to deliver compressions that meet established medical guidelines for CPR (e.g., AHA guidelines for depth, rate, recoil). The text does not elaborate on how this "ground truth" was explicitly measured or used in the "functional tests."

8. The sample size for the training set

• Missing from the text. No training set is mentioned as this is a mechanical device, not a machine learning algorithm requiring a training set in the typical sense.

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

• Missing from the text. See point 8.

Summary of Device and Regulatory Context (from the provided text):

• Device Name: Jolife's Modified LUCAS® External Cardiac Compressor (referred to as LUCAS®)
• Intended Use: Performing external cardiac compressions on adult patients with acute circulatory arrest (absence of spontaneous breathing and pulse, loss of consciousness), where manual chest compression would be used. Intended for temporary use.
• Mechanism: Pneumatically powered mechanical chest compression system with an upper part containing a pneumatically driven piston rod and a pressure pad integrated into a suction cup.
• Modification in K062401: This 510(k) is for a modification to re-introduce "active decompression" by eliminating holes in the suction cup, which were previously added to "deactivate" this component. The sponsor states active decompression will be limited to 3lbs. The FDA considered this a "change in fundamental scientific technology as compared to the predicate [compression only] device" and required clinical data for the active decompression component.
• Predicate Devices: Lucas (K053403), Thumper model 1007 (K972525), Autopulse model 100 (K040453).
• Substantial Equivalence: The submission claims substantial equivalence based on indications for use, basic overall function, and materials used being equivalent to predicate products.
• Testing: "Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety and capability of LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected."

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the modified LUCAS® device to predicate devices through functional testing and comparison of core features, rather than presenting detailed acceptance criteria and a study demonstrating the device's performance against those criteria in a quantitative, clinical manner. It highlights the FDA's concern regarding the active decompression feature, deeming it a "fundamental scientific change" that would typically require clinical data, but the document does not present such data.

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LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontancous breathing and pulse, and loss of consciousness.

LUCAS® can be used in cases where manual chest compression would be used.

LUCAS® is only intended for temporary use.

LUCAS is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.

LUCAS consists of an upper part containing a pneumatically driven piston rod, which acts on the patient's 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.

LUCAS can be powered by oxygen or air from a wall outlet in a hospital or an ambulance, or from a cylinder.

LUCAS is designed to provide:

• · Consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
• · Good circulation during the patient transport process;
• · Safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS delivers continuous, consistent and uninterrupted compressions;
• · Hands-free compressions in any situation.

LUCAS can be applied to the patient in less than 20 seconds.

This document, K053403, is a 510(k) summary for the LUCAS® external cardiac compressor. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria.

The document 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 and capability of the LUCAS comply with the product specifications and supports substantial equivalence to predicate devices." However, it does not provide details of these tests, specific acceptance criteria, or the reported performance data in a quantifiable manner.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, or specific study designs (such as MRMC or standalone studies), as this information is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Thumper 1007 and Autopulse model 100) based on similar function, indications for use, and materials, rather than presenting a performance study against novel acceptance criteria.

Key takeaway: This 510(k) summary does not include the detailed performance study information you are asking for. It asserts that testing was done and compliance achieved, but does not provide the specifics of those tests or results.

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