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TEETHMATE DESENSITIZER is indicated for reduction of tooth hypersensitivity by the following treatments:

[1] Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease and/or acid erosion

[2] Treatment of dentin after mechanical tooth cleaning, scaling and/or root planing

[3] Treatment of tooth surface before and/ or after bleaching

[4] Treatment of prepared dentin for fillings and/or prosthetic restorations

The subject device consists of POWDER which contains Calcium Phosphate as a major component and LIQUID which mainly contains water. POWDER and LIQUID are mixed to obtain paste. The paste applied to the affected area transforms to a hardened material of hydroxyapatite and it suppresses hypersensitivity by sealing the dentin tubules and microcracks in the enamel.

The provided text describes a 510(k) premarket notification for a medical device called TEETHMATE DESENSITIZER. This submission is for a partial change to a predicate device, specifically altering the wording of one "Indications for use" statement.

The core of the submission argues for substantial equivalence to the predicate device, K122421, rather than presenting a new study with explicit acceptance criteria and device performance metrics in the format requested. The document states that the effectiveness and performance are "substantially equivalent" because the chemical ingredients, hypersensitivity-suppressing mechanism, and technological characteristics are the same as the predicate device.

Therefore, many of the requested fields cannot be directly extracted from the provided text as it focuses on demonstrating equivalence rather than reporting on a new performance study with specific acceptance criteria and detailed study methodology for the modified device.

However, based on the information provided, here's what can be inferred and explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (K122421) under the modified indication for use. This means demonstrating that the device is as safe and effective as a legally marketed device. The specific criteria for demonstrating this substantial equivalence are outlined by the FDA's 510(k) regulations, which in this case, focus on:
  • Same intended uses (with the minor modification in wording)
  • Same chemical ingredients/safety
  • Same technological characteristics/effectiveness and performance
  • Same biocompatibility
• Reported Device Performance: The document doesn't provide quantitative performance metrics for "TEETHMATE DESENSITIZER" against a new set of acceptance criteria. Instead, it asserts its performance is equivalent to the predicate.
  • It does mention two specific investigations regarding the effect of the modification:
    • "it was confirmed that there was no difference in sealing performance between before and after bleaching teeth when investigated the ability of the subject device to seal microcracks in the enamel before and after bleaching."
    • "it was confirmed that the subject device used before bleaching did not affect the bleaching performance when investigated the effect of the subject device on the performance of the bleaching material."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document refers to "investigated the ability of the subject device to seal microcrecks" and "investigated the effect of the subject device on the performance of the bleaching material," but does not provide details on the sample sizes used for these investigations.
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from "Kuraray Noritake Dental Inc." which is based in Japan, it's possible the testing was conducted in Japan, but this is not confirmed. The study type appears to be internal verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable/Not specified. The document describes internal investigations rather than clinical studies involving expert consensus on ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not specified.

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. This is not an AI/software device, and no MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a dental desensitizing material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the limited investigations mentioned (sealing performance and effect on bleaching) would likely be in-vitro laboratory measurements or potentially small-scale in-vivo observations. The document states, "it was confirmed that there was no difference in sealing performance..." and "...it was confirmed that the subject device used before bleaching did not affect the bleaching performance...". This suggests direct measurement of physical properties (e.g., microcrack sealing) and functional outcomes (e.g., bleaching efficacy).

8. The sample size for the training set

• Not applicable. This is a partial change application for a physical dental device. There is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no training set for this type of device.

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