(108 days)
The Headrest® with Nasal Seal is a reusable accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
The Headrest® with Nasal Seal is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP. The Headrest® with Nasal Seal is initially used under the direct supervision of a trained medical professional. The Headrest® with Nasal Seal function and applications are applied in a clinical or home setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy. The Headrest® with Nasal Seal has three significant components: 1) Headrest, 2) Nasal Seal, and 3) Tubing. The Headrest holds the device Tubing and the Nasal Seal in place on the user's head. The Headrest is adjustable by the user. The Nasal Seal is made from a silicone material which connects to the Headrest. The Nasal Seal provides the airflow pathway to the user's nasal openings. The Tubing connects to the CPAP System. The Tubing and Headrest pass the constant air pressure of the CPAP System to the Nasal Seal. The Headrest allows the positioning of the Nasal Seal for the comfort of the user. The Headrest and Nasal Seal are reusable components. The Tubing is single patient use.
This document is a 510(k) summary for the AEIOMed Reusable Headrest® with Nasal Seal, an accessory for CPAP devices used to treat Obstructive Sleep Apnea. It covers the device description, intended use, technology, and conclusion of substantial equivalence to predicate devices. However, it does not provide the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as requested in the prompt.
Specifically, the document does not provide information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document mentions "Laboratory testing and guidance document compliance were provided to support the reusable Headrest with Nasal Seal Instructions for cleaning and disinfection, and performance after cleaning and disinfection." However, it does not detail the nature of this "laboratory testing," the specific metrics or acceptance criteria used, or the results. It only states that the device "continued to meet specifications" after 30 cleaning and disinfection cycles, which is a very high-level statement without supporting data.
Conclusion:
Based on the provided text, it is not possible to answer the detailed questions regarding acceptance criteria and the specifics of the study proving device performance. The document focuses on regulatory summary and substantial equivalence to predicate devices rather than a detailed performance study report.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).