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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

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.

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