Search Results

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)

Comparison of Compower Non-Rebreathing Valve to Seal Rite™ Non-Rebreathing Valve (Predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set for performance testing, nor does it detail the country of origin for the data or whether it was retrospective or prospective. The non-clinical testing was conducted to confirm conformance to specified requirements, implying internal laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

N/A. This type of information (experts, ground truth for test set, qualifications) is typically relevant for studies involving subjective interpretation (e.g., medical imaging AI). For medical devices like CPR masks and valves, performance is assessed through objective, quantifiable non-clinical tests based on engineering standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically used in clinical studies or studies requiring expert consensus for ground truth, which is not applicable to the non-clinical testing described for these devices.

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

N/A. This is a non-AI medical device. MRMC studies are not applicable.

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

N/A. This is a non-AI medical device. Standalone algorithm performance is not applicable.

7. The type of ground truth used

For the non-clinical performance and biocompatibility testing, the "ground truth" was established by objective measurements against established international and national standards (ISO 5356-1, AS 4259-1995, ISO 10993 series) and product specifications. This means the device's performance was compared to predefined, quantifiable limits and characteristics outlined in these standards.

8. The sample size for the training set

N/A. There is no "training set" as this is not an AI/ML device. The device design and materials are based on established engineering principles and comparison to existing predicate devices.

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

N/A. There is no "training set" or corresponding ground truth for this type of device.

Ask a specific question about this device