(84 days)
To reduce or alleviate snoring by holding the tongue and lower jaw in a 60-75% of patient maximum protrusion forward position during sleep.
The Snore Peace® is a single piece device which is form custom fitted to the users upper and lower teeth and inner lips. It is meant to be worn at night while sleeping.
Here's an analysis based on the provided document:
This 510(k) submission for the Snore Peace® device does not contain specific acceptance criteria or a study proving that the device meets those criteria. Instead, it relies on a claim of "substantial equivalence" to predicate devices.
Summary of Information - K981923 (Snore Peace®)
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not specified Not specified Explanation: The document states, "The effectiveness and suitability to the intended purpose of The Snore Peace® is assured via the widespread use and length of use of the many similar devices on the market." This is a qualitative claim based on predicate device performance, not a set of quantitative acceptance criteria for the Snore Peace® itself.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No specific test set or study data for the Snore Peace® device is presented.
- Data Provenance: Not applicable.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth establishment for a test set is described.
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Adjudication Method for the Test Set:
- Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No.
- Effect size of human readers with vs. without AI: Not applicable.
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Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Was it done? No. The Snore Peace® is a physical anti-snoring device, not an algorithm.
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Type of Ground Truth Used:
- Not applicable. The submission relies on "widespread use and length of use of the many similar devices on the market" rather than specific ground truth data for the Snore Peace®.
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Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device requiring a training set.
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How Ground Truth for the Training Set Was Established:
- Not applicable.
Conclusion from the Provided Document:
The K981923 submission for the Snore Peace® device does not include a study with defined acceptance criteria and evidence of the device meeting those criteria. Instead, the submission relies entirely on a claim of substantial equivalence to existing legally marketed predicate devices. The rationale is that because similar devices are already on the market and have been used widely for a long time, the Snore Peace®, having a similar design and intended use, should also be considered safe and effective. This is a common pathway for medical device clearance, particularly for devices deemed unclassified or low-risk, where new clinical data demonstrating effectiveness against specific endpoints may not be required if substantial equivalence can be demonstrated.
§ 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.”