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The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel.

The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation.

HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are modifications to the pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator. The HLR Model-601 and the HeartSaver 100 are compact, totally portable, automatic CPR Devices. The HLR Model-601 and the HeartSaver 100 are air-powered medical devices used for emergency resuscitation of patients who have stopped spontaneous breathing. The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines. The devices can control the depth of chest compressions and the volume of ventilation. The HLR Model-601 and the HeartSaver 100 allow the trained user three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without ventilation.

The provided text describes a Special 510(k) submission for the HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific performance acceptance criteria.

Based on the provided text, the following information can be extracted regarding acceptance criteria and a "study":

1. Table of acceptance criteria and the reported device performance:

Note: The document states that "Verification and validation testing demonstrated that the modified devices... conform to design and performance specifications," but it does not provide the specific numerical acceptance criteria for these specifications or the raw data/results of said testing. The primary "study" referred to is the comparison to the predicate device to establish substantial equivalence.

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

• Sample Size: Not specified. The document only mentions "Verification and validation testing" without detailing the number of units tested or specific test cases.
• Data Provenance: Not specified. It's likely that the testing was conducted internally by Medical Products Mfg., LLC, but the country of origin of testing data or whether it was retrospective/prospective is not mentioned.

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

This information is not provided in the document. The submission relies on "Verification and validation testing" and a claim of conformance to specifications and substantial equivalence, not a review by external experts to establish a "ground truth" for a test set in the context of AI/diagnostic device evaluation.

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

This information is not provided. As the document does not detail an expert review process for a test set, there is no mention of an adjudication method.

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, an MRMC comparative effectiveness study was not conducted. This device is a medical device for resuscitation, not an AI-powered diagnostic or assistive tool for human readers. It functions as an automatic CPR device.
• Effect Size: Not applicable.

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

• This is not an AI algorithm. The device, the HLR™ Model-601 and HeartSaver 100, is a standalone medical device designed to perform automatic CPR without continuous human intervention during the resuscitation action, although it is administered by trained medical personnel. The "performance testing" mentioned effectively serves as the standalone performance evaluation for the device's mechanical and operational functions against its design specifications and AHA guidelines. The document states it "provide automatic chest compressions and ventilation."

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

The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for disease presence) is not applicable here in the traditional sense. For this device, the "ground truth" for its performance is its conformance to established engineering design and performance specifications, and its ability to deliver CPR parameters (compression depth, ventilation volume, ratios) as defined by the current American Heart Association Guidelines. Whether these guidelines were strictly adhered to and measured during verification and validation testing would constitute the "ground truth" for device operation.

8. The sample size for the training set:

• Training Set: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

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