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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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