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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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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.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

This device description is for the AutoPulse Resuscitation System Model 100, an automated chest compression device.

Based on the provided text, there is no specific acceptance criteria or detailed study results that prove the device meets acceptance criteria mentioned.

The document states:

• "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Section 1)

However, it does not provide any data, metrics, or specific acceptance criteria that were used in this testing. It only concludes that the device is "substantially equivalent" to predicate products based on indications for use, basic overall function, and materials.

Therefore, I cannot populate the requested table or provide details for most of the other questions.

Here's an assessment based on the available information:

1. Table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set details or ground truth establishment are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an automated mechanical device, not an AI-based diagnostic or assistive system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device itself as an "automated, portable, battery powered device that compresses the chest." While its performance would inherently be standalone in its function, no specific "standalone performance study" details (like accuracy or efficacy metrics) are provided. It operates as an adjunct to manual CPR, implying it's often used with human oversight, but its core function is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not a machine learning model with a training set.
9. How the ground truth for the training set was established: Not applicable.

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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.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

The provided text describes a 510(k) submission for the AutoPulse™ Resuscitation System Model 100, which is an automated chest compression device. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as requested.

The document states:

• "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Page 1, "Testing" section)
• "The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent." (Page 1, "Summary of Substantial Equivalence" section)

This indicates that some testing was performed to demonstrate substantial equivalence to predicate devices (Thumper™ Model 1005, K011046, and K022345), but the specifics of what those tests were, what the acceptance criteria were, and what the reported performance was are not included in this document.

Therefore, I cannot populate the table or answer most of the follow-up questions from the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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: Not specified. This device is an automated chest compressor, not an AI-assisted diagnostic tool, so an MRMC study in the context of "human readers" is unlikely to be relevant here.

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

• This device is inherently "standalone" in its operation as an automated chest compressor, but no specific study reporting its standalone performance metrics are provided in this document. The term "algorithm only" might not directly apply in the same way it would to a diagnostic AI, but the device's mechanical performance would be its standalone metric.

7. The type of ground truth used

• Type of ground truth: Not specified. For a resuscitation system, ground truth would typically relate to physiological parameters (e.g., blood flow, chest compression depth/rate) or clinical outcomes, but this is not detailed.

8. The sample size for the training set

• Sample size: Not specified.

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

• Ground truth establishment: Not specified.

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