FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

The provided document describes the TEETHMATE DESENSITIZER device and its substantial equivalence to a predicate device, SUPER SEAL. The manufacturer's goal is to demonstrate that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be > 90%"). Instead, it focuses on demonstrating "substantial equivalence" to the predicate device, SUPER SEAL, in terms of effectiveness and performance. The acceptance criteria are implicitly defined by showing comparable outcomes to the predicate device across specific performance tests.

Acceptance Criteria	Reported Device Performance (TEETHMATE DESENSITIZER vs. SUPER SEAL)
Effectiveness and Performance:
Occlusion of dentinal tubules	The subject device (TEETHMATE DESENSITIZER) "transforms to a hardened material of hydroxyapatite and it suppresses hypersensitivity by sealing the dentin tubules and microcracks in the enamel." This is compared to SUPER SEAL which "demineralizes the organic and mineral debris... and restructures the demineralized material as a calcium oxalate precipitate. It creates an acid resistant lining layer bound both to the surface as well as into the dentinal tubules." Both devices achieve the goal of occluding dentinal tubules to reduce hypersensitivity, though by different mechanisms. The study concluded that the subject device was "substantially equivalent in effectiveness and performance" with respect to occlusion of dentinal tubules.
Dentin permeability inhibition	The study evaluated "dentin permeability inhibition" and concluded that the subject device was "substantially equivalent in effectiveness and performance" to the predicate device. Specific data or metrics for the inhibition were not provided in this summary.
Tensile bond strength to bovine dentin	The study evaluated "tensile bond strength to bovine dentin when used with bonding agent and composite resin" and concluded that the subject device was "substantially equivalent in effectiveness and performance" to the predicate device. Specific data or metrics were not provided in this summary.
Biocompatibility:	The subject device was evaluated referring to ISO 10993 series and ISO 7405. The results confirmed its biocompatibility, and it was concluded that the subject device was "substantially equivalent in biological safety to the predicate device."

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the test set for any of the performance studies (Occlusion of dentinal tubules, dentin permeability inhibition, tensile bond strength).
- The provenance for the tensile bond strength test is "bovine dentin," indicating an in vitro study using animal teeth. The provenance for the other tests is not explicitly stated but implies in vitro or potentially ex vivo lab studies, as human clinical data is not mentioned in this section.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are non-clinical, focusing on material science and dental properties rather than clinical outcomes requiring expert interpretation of patient data.
Adjudication method for the test set:
- This information is not applicable/provided. The studies are non-clinical performance tests, not clinical evaluations requiring adjudication of expert interpretations.
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 type of study was not done. This device is a dental material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental material, not an algorithm. The performance evaluation is standalone in the sense that it's evaluating the material's properties directly, without human intervention in the application of the material during the test, beyond standard lab procedures.
The type of ground truth used:
- For the non-clinical performance studies ("Occlusion of dentinal tubules," "dentin permeability inhibition," and "tensile bond strength"), the "ground truth" is established through direct measurement and comparison to an established predicate device's performance using standardized laboratory methods. For biocompatibility, the ground truth is established by adherence to international standards (ISO 10993 series and ISO 7405).
The sample size for the training set:
- This information is not applicable/provided. The document describes the evaluation of a dental material, not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

Summary

Regulation Number and Section

§ 872.3250 Calcium hydroxide cavity liner.

(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.