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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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