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K Number
K072968
Device Name
STRESSGARD NIGHTGUARD
Manufacturer
TOTALGARD CORPORATION
Date Cleared
2008-07-01

(253 days)

Product Code
OBR
Regulation Number
N/A
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K053580,K072147,K071404
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Stressgard™ Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.

Device Description

The TotalGard™ Stressgard™ Night Guard is composed entirely of a soft, flexible semitransparent FDA compliant material, Monprene® thermoplastic elastomers. As packaged, the Stressgard ™ Night Guard is ready for use by the consumer. If desired, the Stressgard™ Night Guard is easily trimmed by the consumer, however it requires no forming or molding for use.

AI/ML Overview

Here's an analysis of the provided text regarding the Stressgard™ Night Guard, focusing on the absence of performance data:

The provided 510(k) summary for the Total-Gard Corporation Stressgard™ Night Guard (K072968) explicitly states:

VIII PERFORMANCE DATA
No performance data is required in support of this 510(k) Notification.

This means that no specific acceptance criteria or study data demonstrating the device meets those criteria were provided or required for this particular submission. The FDA granted substantial equivalence based on other factors.

Therefore, I cannot populate the requested information regarding acceptance criteria and study details because the submission itself declares that no such data was needed.

Here’s a breakdown of what can be inferred from the document and why no further information is available for your specific questions:

  1. A table of acceptance criteria and the reported device performance: Not applicable. No performance data was required or provided.
  2. Sample size used for the test set and the data provenance: Not applicable. No test set data was required or provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set was established as no performance study was conducted.
  4. Adjudication method: Not applicable. No performance study or ground truth establishment was conducted.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for evaluating diagnostic accuracy with human readers and AI. The Stressgard™ Night Guard is a physical device, and its 510(k) submission did not involve such a study.
  6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: No. This device is a physical night guard, not an algorithm, and no such standalone performance study was conducted or required.
  7. The type of ground truth used: Not applicable. No ground truth was established as no performance study was conducted.
  8. The sample size for the training set: Not applicable. This refers to machine learning algorithms, which is not relevant for this physical device.
  9. How the ground truth for the training set was established: Not applicable. This refers to machine learning algorithms.

Reasoning for "Not Applicable" or "No Data Provided":

The basis for the 510(k) clearance was "Substantial Equivalence" to predicate devices, as explained under section IX of the summary:

IX SUBSTANTIAL EQUIVALENCE
"The TotalGard™ Stressgard™ Night Guard is as safe and effective as the predicate devices. With respect to the physical composition of the Stressgard™ Night Guard, not unlike the predicate devices, the Stressgard™ Night Guard is comprised of FDA compliant Monprene® which has been determined to be safe and effective for use in FDA cleared medical devices. The Stressgard™ Night Guard has similar intended uses and indications as the predicate devices and the labeling and instructions are appropriate for over the counter use. As a result, the TotalGard™ Stressgard™ Night Guard is substantially equivalent to the predicate devices with respect to safety and effectiveness."

This means the FDA determined that because the device is made of similar materials (FDA compliant Monprene®), has comparable intended uses and indications as already cleared predicate devices (K053580, K072147, K071404), and appropriate labeling, it does not raise new questions of safety or effectiveness. Therefore, the detailed performance data typically associated with new or significantly different devices was not required for this submission.

N/A