(126 days)
The Lamberg Sleep Well device is intended to reduce night time snoring. The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.
The Lamberg Sleep Well device is a one piece, custom-molded device that advances the mandible by 5 mm. The body of the device extends over the upper incisors, and is 2 – 3 mm thick. A central protrusive element hangs down to contact the lingual lower incisors. An Adams clasp is placed to hold the device securely to each of the upper first molars. The appliance ends at the distal of the first molars on the palate.
The provided text describes a 510(k) summary for the "Lamberg Sleep Well Device." Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Data | N/A | "No performance data are required in support of this 510(k) notice." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation explicitly states, "No performance data are required in support of this 510(k) notice." Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective) for a study demonstrating performance. The device's clearance is based on substantial equivalence to predicate devices, not on a new performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no performance data was required and no study was conducted, there were no experts used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no performance study was conducted, there was no adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The document focuses on substantial equivalence, not comparative effectiveness. Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was conducted or mentioned. The device described is a physical mandibular advancement device, not an algorithm.
7. Type of Ground Truth Used
No performance study was conducted, so no ground truth was established or used.
8. Sample Size for the Training Set
No performance study was conducted for the Lamberg Sleep Well Device itself in this submission, and it's a physical device, not an AI/algorithm that typically requires a training set. Therefore, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
Since no training set was used for this device, there is no information on how ground truth for a training set was established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
Based on the provided 510(k) summary, there was no specific study conducted to prove that the Lamberg Sleep Well Device meets acceptance criteria through performance data. Instead, the device received 510(k) clearance based on its substantial equivalence to predicate devices. The submission asserts that:
- The Lamberg Sleep Well device has the same intended uses and similar indications as its predicate device (TheraSnore - K973038).
- It shares similar technological characteristics and principles of operation with the predicate device.
- The minor technological differences between the Lamberg Sleep Well device and its predicate devices "raise no new issues of safety or effectiveness."
The FDA concurred with this assessment, stating that the device is substantially equivalent to legally marketed predicate devices and thus permits it to proceed to the market under general controls provisions.
§ 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.”