Search Results

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:

• Adult is indicated for use on adults >40 kg. .
• Child is indicated for use on children 10 40 kg. .
• · Infant is indicated for use on infants 5 10 kg

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.

The DMR2 Plus™ is available in three sizes: adult, child and infant. It may be used by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated; such as, hospital, transport, mobile and home.

The DMR2 Plus™ consists of a compressible resuscitator bag that is available in either processed natural rubber or PVC. The swivel, patient connection and CO2 detector cartridge are connected to the nonrebreathing Valve (NRV) housing - all housings are K-resin. The oxygen accumulator assembly enables the use of three different styles of oxygen accumulators: large bore, small bore or flat bag.

During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The provided text does not contain specific acceptance criteria with numerical targets or detailed results of a study designed to prove the device meets those criteria. Instead, it states that "The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing." It then lists the standards and guidance followed for this testing.

Therefore, the requested information cannot be fully extracted as there is no table of acceptance criteria with reported device performance, information on sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

Based on the provided text, here is what can be inferred and stated:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria (e.g., minimum flow rates, CO2 detection thresholds, etc.) or quantitative reported device performance data. It broadly states that the device was tested to relevant standards, implying it met the general requirements of those standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

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)

This information is not provided in the document. The CO2 detection relies on "color comparison," which typically implies a visual assessment by a healthcare professional rather than a complex ground truth establishment process involving multiple experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 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

No such study is mentioned or implied. The device is a manual resuscitator with an integrated CO2 detector, which is a physical device providing a direct visual indication (color change) rather than an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a manual resuscitator with a simple integrated CO2 detector (color comparison), not an algorithm or AI system. Its function is to provide a visual cue for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the CO2 detection aspect, the "ground truth" would likely be based on actual CO2 levels as measured by a gold-standard CO2 analyzer, or verification of endotracheal tube placement by other clinical methods (e.g., direct visualization). However, the document only states that the detector "detects approximate ranges of CO2 by color comparison," indicating a visual, qualitative assessment. The safety and effectiveness demonstrations relied on adherence to international standards for resuscitators (ISO 8382, ISO 5356-1, ASTM F 920-93) and environmental testing. These standards define performance requirements and test methods for the physical and functional aspects of the device, rather than requiring a complex "ground truth" as might be seen for diagnostic imaging.

8. The sample size for the training set

This information is not provided in the document and is not applicable given the nature of the device (not an AI/learning algorithm).

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

This information is not provided in the document and is not applicable given the nature of the device.

Ask a specific question about this device