(55 days)
The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.
The Koo Americas Valve PEEP is an adjustable valve, which is placed in a circuit and provides for positive end expiratory pressure for the patient. It is spring actuated and is a single patient use device. It is clear in construction allowing confirmation of functionality. Graduated markings allow for confirmation of settings. A convenience connector is provided to allow for conversion to 22mm. The connector is a male 30mm that connects to the female Peep Valve to provide 22mm.
The provided text describes a medical device, the "Koo Americas Valve PEEP," and its substantial equivalence to a predicate device for FDA clearance (K050918). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a 510(k) summary and the FDA's clearance letter, which focuses on regulatory approval based on equivalence to an existing device rather than detailed performance study results that would typically include the requested information.
Therefore, I cannot provide the requested information from the provided text. The output will be a statement indicating the absence of this information in the input.
Output:
The provided document (K050918) describes the "Koo Americas Valve PEEP" and its FDA clearance based on substantial equivalence to a predicate device. However, the document does not contain information regarding:
- Acceptance criteria and reported device performance.
- Sample sizes used for test sets or their data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a regulatory submission summary and clearance letter, which typically does not include the detailed performance study data requested.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).