(98 days)
- Intended Use: to prevent the soft palate from contributing to the airway restrictions that cause snoring.
- Indications for Use: treatment of snoring.
The soft palate elevator consists of an upper base appliance with a palatal plate from which a thin flat metal arm extends posterior end to terminate in a silicone rubber bulb that raises the center of the soft palate in order to "tent" that flexible structure to draw its distal end upward and forward away from the pharyngeal wall and to tighten the pharyngeal wall. The front end of the arm contains undercut tabs that extend out to the sides to lock into the acrylic in the palatal plate of the base appliance, and the back end of the arm contains features engineered to retain the rubber bulb. The arm is strong enough to elevate the middle of the soft palate about ¼'' when it is at rest during sleep and also flexible enough to move up and down with the natural action of the soft palate during swallowing when breathing stops anyway.
This document describes a 510(k) premarket notification for a medical device called the "Soft Palate Elevator," intended for the treatment of snoring. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML powered device.
Here's why and what information is missing:
- Device Type: The Soft Palate Elevator is a physical intraoral device, not an AI/ML powered diagnostic or therapeutic tool. Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically applied to AI performance (e.g., sensitivity, specificity, AUC) is not applicable here.
- No AI/ML Component: The document details the device's mechanical and material properties, its intended use, and a comparison to a predicate device. There is no mention of an algorithm, AI, or machine learning being part of this device.
- Testing: The document mentions "bench testing" for comparing the subject device and predicate, and "biocompatibility testing." It explicitly states, "Clinical testing was not performed." This means there is no clinical study data presented to demonstrate performance against specific clinical acceptance criteria in humans.
Therefore, I cannot fulfill your request for the following reasons:
- AI/ML Performance Metrics: The device described is a mechanical device, not an AI/ML system. There are no AI performance metrics (like sensitivity, specificity, AUC) or related acceptance criteria mentioned.
- Test Set Details: No test set (for an AI model) is described.
- Ground Truth Experts/Adjudication: These concepts are relevant to establishing ground truth for AI model training/testing, which is not applicable to this mechanical device.
- MRMC Study: No clinical study, let alone an MRMC study, was performed or reported.
- Standalone Performance: Not applicable to a non-AI device.
- Type of Ground Truth: Not relevant in the context of a mechanical device's 510(k) submission.
- Training Set Details: There is no AI model, so no training set.
- Ground Truth Establishment for Training: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (the adjustable soft palate lifter, K895189) based on similar intended use, indications for use, and technological characteristics (while highlighting key differences in materials and force application). The "acceptance criteria" for a physical device like this in a 510(k) submission are typically related to biocompatibility, mechanical durability, and safety, demonstrated through bench testing and material characterization, rather than clinical efficacy metrics.
§ 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.”