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The SIMS 1st Response Manual Adult Resuscitator is a pulmonary-assist device intended to provide respiratory support to adult patients suffering from respiratory distress by forcing a volume of fresh gas into the patient via compression of the ventilator bag.

SIMS 1st Response™ Manual Resuscitator, Adult

This FDA letter is a 510(k) clearance document for the SIMS 1st Response™ Manual Resuscitator, Adult. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific acceptance criteria for device performance or a study proving it meets those criteria, as typically found in a clinical study report or a more detailed submission. 510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technological characteristics and intended use, rather than extensive clinical performance studies for novel devices.

Therefore, for your questions regarding acceptance criteria and a study proving their fulfillment, the provided document does not contain the necessary information.

To elaborate:

• 1. A table of acceptance criteria and the reported device performance: Not present in this document.
• 2. Sample size used for the test set and the data provenance: Not present in this document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in this document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in this document.
• 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, as this is a manual resuscitator, not an AI-assisted diagnostic device, and such a study is not mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a manual resuscitator.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in this document.
• 8. The sample size for the training set: Not applicable, as this is a medical device, not a machine learning algorithm, and no training set is mentioned.
• 9. How the ground truth for the training set was established: Not applicable, as this is a medical device, not a machine learning algorithm.

This FDA letter primarily confirms the regulatory clearance based on substantial equivalence, rather than detailing a specific performance study.

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