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The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without additional oxygen. The child model is intended for patients weighing less than 30kg. The adult model is intended for patients weighing more than 30kg.

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This is a 510(k) premarket notification for a medical device (STURDY Manual Resuscitator), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, ground truth, and training sets is not applicable in this context.

The document indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning it meets the safety and effectiveness standards without requiring extensive de novo studies like those typically associated with new AI/ML technologies.

The acceptance criteria for a traditional medical device like a manual resuscitator would typically involve performance specifications for characteristics such as:

• Volume delivery: The amount of air delivered per squeeze.
• Leakage: Ensuring no significant air leakage from the device.
• Operating pressure: The pressure generated during manual ventilation.
• Patient valve resistance: Resistance to airflow through the patient valve.
• Exhalation valve function: Proper operation of the exhalation valve.
• Material biocompatibility: Ensuring materials are safe for patient contact.
• Sterilization efficacy (if applicable): For reusable devices, the ability to be effectively sterilized.
• Durability and functional life: How long the device can perform as intended.

These criteria are typically established through recognized standards (e.g., ISO standards for medical devices) and verified through bench testing, mechanical testing, and potentially some limited human factors or simulated use testing, rather than the types of clinical studies and expert reviews you'd see for AI/ML diagnostic tools.

Since this is not an AI/ML device, the specific questions about sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not relevant to this submission.

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