(86 days)
PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep.
PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.
The provided text describes the regulatory clearance for the "PillowPositive Cervical Pillow" and includes a summary of performance data from a pilot study and a pivotal study. However, it does not explicitly define acceptance criteria as a table with specific metrics or detail the study methodology with the granularity requested in the prompt.
Based on the provided text, here's an attempt to extract and infer the information:
1. Table of acceptance criteria and reported device performance:
The document states that the PillowPositive reduces the Respiratory Disturbance Index (RDI), which is defined as apneas and hypopneas, in subjects with mild obstructive sleep apnea. It also mentions "statistically significant reduction." However, it does not provide specific numerical thresholds or target values for this reduction to constitute "acceptance criteria."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction in Respiratory Disturbance Index (RDI) | Pivotal Study: Produces a statistically significant reduction in RDI. |
| (No specific quantitative target or lower bound for reduction) | Pilot Study: Showed a statistically significant reduction in RDI. |
| Safety and Effectiveness (Relative to predicates) | No new issues of safety and effectiveness compared to predicate devices. |
| Similar intended use, principles of operation, and technological characteristics to predicate devices | Has the same intended use as Dr. Jonathan A. Parker's PM Positioner and Adjustable PM Positioner. Similar principles of operation to PM Positioner, Adjustable PM Positioner, and A-Just Right Pillow. Similar technological features to Ortho-Rest Company's A-Just Right Pillow. Minor differences present no new issues of safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either the pilot or pivotal study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted "to assess the PillowPositive's use."
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 studies assess the product's effect on RDI, which is typically measured by polysomnography, but the details of who interpreted these studies are not mentioned.
4. Adjudication method 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:
This is not applicable to this device. The PillowPositive Cervical Pillow is a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the PillowPositive is a physical medical device and not an algorithm.
7. The type of ground truth used:
The "ground truth" for evaluating the device's performance appears to be the Respiratory Disturbance Index (RDI), which is an objective physiological measure obtained through sleep studies (polysomnography).
8. The sample size for the training set:
There is no mention of a training set as this is a physical medical device undergoing clinical studies, not an AI algorithm.
9. How the ground truth for the training set was established:
This question is not applicable as there is no training set mentioned in the context of this device.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”