(367 days)
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilation used for ventilation and oxygen inhalation with either a mask or tube.
Patient groups
Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate.
Users Qualified medical personnel only
Intended environments of use
· Mobile use for emergency medicine and primary care during emergency deployments
· During land or air transport or transfer between hospital rooms and departments
MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator. Highly compressed medical oxygen is used as the ventilation gas; this is reduced to the necessary operating pressure via an external pressure reducer. The oxygen is supplied at the compressed gas connection. The ventilation parameters – frequency and tidal volume - are linked together and can be set using the adjusting knob on the device. The ventilation gas is transported to the patient through the ventilation hose via the patient valve and ventilation mask or via the tube. The lip membrane in the patient valve allows the patient exhalation of expiration gas. In order to monitor the patient, the device features continuous measurement of the airway pressure as well as a visual and audible alarm system.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the MEDUMAT Easy CPR device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" for each performance metric in a table format with specific numerical targets. Instead, it states that various tests were conducted to "verify the safety and effectiveness" and that "the performance of MEDUMAT Easy CPR is at least as good as the performance of the predicate device." The "Test results" section for performance testing only indicates "Passed."
However, we can infer some criteria and reported performance from the comparison table and performance testing section.
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993 and ISO 18562 series standards | Passed (Non-cytotoxic, non-sensitizer, non-irritant, no systemic toxicity, exposures to particulates and VOCs unlikely to result in toxicological effects, no organic compounds identified as leachable) |
| EMC and Electrical Safety | Meet IEC 60601-1-2, -6, -8, -12 and AIM 7351731 standards | Passed |
| Ventilation Mode Characteristics (IPPV, Manual Mode) | Similar to predicate device (Pneupac VR1 Standard) | Passed |
| Demand Flow Mode (Inspiration Trigger, Expiration Trigger, Flow) | Similar to predicate device (Pneupac VR1 Standard) | Passed |
| Pressure Limits | Similar to predicate device (Pneupac VR1 Standard) | Passed (Differences noted but determined not to raise additional concerns) |
| Endurance and Functional Test of Pressure Relief Valve / Safety Valve | Functional operation and endurance | Passed |
| Inspiratory and Expiratory Respiratory Resistances | Comparable to predicate device (Pneupac VR1 Standard) across different operating conditions | Passed |
| Tidal Volume (Vt) Accuracy | ± 40 ml or ± 20% (the larger tolerance applies) | Stated as the tolerance; assumed to be met. (Predicate device has similar tolerances: ±15%) |
| Operating Conditions (Temperature, Air Pressure, Humidity) | Within specified ranges and similar to predicate device | Tested for the subject device; operating conditions are similar and tested. |
| Alerts (High Airway Pressure, Low Airway Pressure, Low gas supply, Low battery) | Functionality as specified | Present and stated to increase safety. (Predicate only has high airway pressure alarm). |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test set in terms of number of devices or data points used for each performance test.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer (Weinmann Emergency Medical Technology GmbH + Co. KG, Germany) or by testing labs on their behalf.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance tests appear to be engineering verification and validation against technical specifications and predicate device performance, rather than clinical studies requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. The performance testing described is objective, technical verification against standards and predicate device characteristics, not subjective assessment requiring adjudication by multiple experts.
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:
This is not applicable. The MEDUMAT Easy CPR is a hardware device (ventilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a ventilator, not an algorithm. Performance testing was done on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance testing can be considered:
- International Standards: For biocompatibility (ISO 10993, ISO 18562) and electrical safety/EMC (IEC 60601 series, AIM 7351731).
- Predicate Device Performance: For ventilation characteristics, pressure limits, demand flow mode, and respiratory resistances, the predicate device (Pneupac VR1 Standard) served as a benchmark for comparison.
- Internal Specifications/Design Requirements: For various technical data and functional tests.
8. The sample size for the training set:
This is not applicable. The MEDUMAT Easy CPR is a hardware medical device and does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).