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K Number
K063229
Device Name
REST ASSURED NITE PROTECTOR
Manufacturer
RANIR LLC
Date Cleared
2006-12-19

(55 days)

Product Code
OBR
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K053580,K024261,K014079,K022809
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.

Device Description

The Rest Assured™ Nite Protector, as packaged, is initially composed of two components: (1) a moldable soft upper component made of Elvax® thermoplastic resin and (2) a hard temporary fitting tray made of biocompatible medical grade Santoprene™ When heated and cooled, the upper Elvax® portion of the mouthguard may be molded to fit the consumer's upper teeth. During the brief fitting process, the Santoprene™ temporary fitting tray maintains the shape of the upper material and prevents the user from biting through the upper material. After the desired fit is achieved, the temporary fitting tray is removed and discarded.

AI/ML Overview

The provided document for K063229, "Ranir Rest Assured™ Nite Protector," explicitly states that "No performance data is required for this 510(k) notice."

Therefore, the following information cannot be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are presented.
  2. Sample sized used for the test set and the data provenance: No test set was used.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established for a test set.
  4. Adjudication method for the test set: No test set, so no adjudication method.
  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: No MRMC study was conducted, as the device is a dental protector, not an AI-based diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
  8. The sample size for the training set: No training set was used.
  9. How the ground truth for the training set was established: No training set, so no ground truth established.

Reason for no performance data:

The 510(k) submission seeks substantial equivalence to predicate devices (K053580, K024261, K014079, K022809). The document argues that the "Rest Assured™ Nite Protector" is substantially equivalent in terms of materials (Elvax® and Santoprene™) and intended use, and therefore no new performance data is required to establish its safety and effectiveness. The FDA concurred with this assessment, granting the 510(k) clearance based on substantial equivalence to already legally marketed devices.

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