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Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg

Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.

The provided text is a 510(k) premarket notification for a medical device (Disposable Manual Resuscitator). This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

Crucially, this document is NOT a study report for an AI/ML powered medical device, nor does it contain information about establishing ground truth, multi-reader multi-case studies, or training sets in the context of AI/ML.

The "Performance Data" and "Summary of Device Testing" sections refer to the physical and functional performance of the manual resuscitator as per established medical device standards (e.g., ISO 10651-4, ISO 5356-1, ISO 10993). These are tests for mechanical and material properties, not an AI algorithm.

Therefore, I cannot extract the information required for bullet points 1 through 9 from the provided text, as those points are specific to the validation of AI/ML systems.

Here's a breakdown of why the requested information cannot be found in this document:

• Acceptance Criteria for AI/ML and Reported Device Performance (Table 1): The document's "Performance Data" section in Table 1 refers to physical characteristics of a manual resuscitator (e.g., "Ventilation Bag Volume," "Max Delivered Volume," "Expiratory resistance," "Supplemental Oxygen%"). These are not acceptance criteria or performance metrics for an AI/ML algorithm.
• Sample Size for Test Set and Data Provenance: This pertains to data used to evaluate AI. The document describes testing of physical products, not data sets.
• Number of Experts and Qualifications for Ground Truth: No AI is involved, so no ground truth established by experts is mentioned.
• Adjudication Method: Not applicable for a non-AI physical device.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This is for evaluating changes in human performance with AI assistance. Not relevant here.
• Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are central to AI/ML model development. The document describes product manufacturing and testing processes, not AI training.

In summary, the provided document details the regulatory submission for a physical medical device (a manual resuscitator) and demonstrates its substantial equivalence to a predicate device based on physical and functional testing. It does not involve any artificial intelligence or machine learning components, and thus the requested details regarding AI/ML acceptance criteria and validation studies are not present.

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The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.

The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use.

The Infant CPR Mask without Oxygen Port is designed to provide immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use.

The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.

Compower Emergency CPR masks with non-rebreathing valves are designed to assist in providing immediate life support to health emergency victims requiring oxygen support and cardiopulmonary resuscitation rescue techniques. The devices subject to this 510(k) include the following: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm).

CPR Mask with Oxygen Port: comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

CPR Mask without Oxygen Port: comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Infant CPR Mask without Oxygen Port: comprised of an air cushion, mask cover and non-rebreathing valve. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Non-Rebreathing Valve: a non-sterile, single-use device designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. Compatible for use with 22mm connectors used in standard ventilation masks. Designed with 15mmOD and 18.5mm ports.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data primarily in the context of comparison to predicate devices, rather than explicit acceptance criteria with pass/fail values. The "acceptance criteria" are implied by meeting or falling within ranges comparable to the predicate devices and adherence to relevant standards.

Comparison of Compower CPR Mask (with/without Oxygen Port) to KYOLING CPR Mask (Predicate)

Comparison of Compower Infant CPR Mask to EMS Child/Infant Mask (Primary Predicate) & Laerdal Paediatric Pocket Mask (Reference)

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