(141 days)
A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
The provided text details the 510(k) summary for the New Stetic Artificial Teeth, which is a preformed plastic denture tooth. The submission asserts substantial equivalence to a predicate device (King Dental Corp - King-Hue, Royal Coral, Super-C Artificial Teeth, K931162).
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The device, New Stetic Artificial Teeth, is a Class II device (Preformed Plastic Denture Tooth) with product code ELM. The performance testing was conducted according to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses.
The text does not explicitly list specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water absorption) or reported device performance values in a table format. Instead, it states that "Performance testing was completed to ISO 22112 First edition 2005-11-01." This implies that the device met all the requirements outlined in this international standard for artificial dental prostheses.
Without specific performance values from the standard or the study, a "reported device performance" column cannot be fully populated with numerical data. However, based on the FDA's clearance, it is understood that the device did meet all applicable criteria within ISO 22112.
| Acceptance Criterion (from ISO 22112) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| (Specific physical, mechanical, and chemical properties as defined by ISO 22112)* | Met all specified requirements of ISO 22112 |
*Note: The 510(k) summary does not reproduce the detailed specifications of ISO 22112. These would typically include tests for properties like bond strength, color stability, water sorption, solubility, hardness, and mechanical strength relevant to dental prostheses.
Study Information
-
Sample sizes used for the test set and the data provenance:
The document does not specify the sample size used for the test set during performance testing. It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted to an international standard (ISO 22112), which dictates testing methodologies but not necessarily data provenance in this context. -
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 510(k) summary. Given that the testing was based on a laboratory standard (ISO 22112) for physical and material properties, the "ground truth" would be established through calibrated laboratory instruments and adherence to testing protocols, rather than expert human interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or provided. Laboratory-based performance testing following an ISO standard typically relies on objective measurements rather than human adjudication of results in the way clinical studies might. -
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 done. This device is a preformed plastic denture tooth, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. The assessment focuses on the material and physical properties of the teeth. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical product (artificial teeth), not an algorithm or software. Its performance is inherent in its material properties and manufacturing. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this type of device is established by objective measurements of material properties and performance characteristics defined by the international standard ISO 22112. This standard specifies tests for things like flexural strength, water absorption, color stability, and bond strength as relevant to artificial teeth. There is no "pathology" or "outcomes data" in the clinical sense for this type of premarket submission, as it relates to the physical product itself. -
The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set." -
How the ground truth for the training set was established:
Not applicable. As there is no training set for a physical product, this question is not relevant.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.