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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 the AutoPulse™ Resuscitation System Model 100, an automatic mechanical chest compressor. However, the document does not contain specific acceptance criteria or study details in the format requested. It states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device" and that "Testing of the device modifications demonstrates the device meets and improves upon the predicate device." This indicates that internal testing was performed, but no details about the methodology, results, or specific criteria are provided.

Therefore, many of the requested fields cannot be populated based on the given information.

Here's an analysis of what can be inferred or what is explicitly missing:

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.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "product testing was conducted."

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

• Not applicable; the testing described is for device conformance and substantial equivalence, not a ground truth establishment by experts for diagnostic or interpretative performance.

4. Adjudication method for the test set

• Not applicable; the testing described is for device conformance and substantial equivalence.

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 device is a mechanical chest compressor, not an AI diagnostic imaging device that would involve human reader interpretation.

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

• The device operates as a standalone mechanical chest compressor, but this question typically refers to the "standalone performance" of an AI algorithm's diagnostic accuracy. The document does not describe such a study for this device.

7. The type of ground truth used

• The document implies that the "ground truth" for its performance would be its ability to perform mechanical chest compressions according to its specifications and "substantially equivalent" to (or improved upon) its predicate device. No external "ground truth" like pathology or outcomes data is mentioned in relation to specific performance metrics for the device itself in this summary.

8. The sample size for the training set

• Not applicable. This device is a mechanical system, not an AI algorithm requiring a training set.

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

• Not applicable.

Conclusion:

The provided 510(k) summary focuses on general device description, intended use, predicate device comparison, and regulatory status. It states that testing was conducted to demonstrate conformance and substantial equivalence but does not provide details about the specific acceptance criteria, study design, sample sizes, or performance metrics that would answer the posed questions. The questions are largely tailored to AI/diagnostic devices, which this medical device (a mechanical chest compressor) is not.

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