Search Results

Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base.

Yamahachi Denture Base Resins is supplied in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) beads with small quantities of initiator and color pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator.

To fabricate the denture base, the powder and liquid materials are mixed together and stirred to create a dough state that is packed or poured into a mold, saddle, or core. The resin then cures either through heat application (water bath, rapid immersion, or microwave oven) or a self-curing process (pressure vessel or via quick-setting).

While heat-cure resins are generally used to fabricate denture bases, self-cure acrylics are most often indicated for repair and relining of the dentures. The subject device includes three heat-cure resins (Basis, Basis HI, and Basis Twin Cure) and two self-cure resins (Basis Flow and Re-Fine Bright).

I am unable to answer most of your questions as this document is a 510(k) summary for a denture base resin, not an AI/ML medical device. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," are not applicable.

However, I can provide the following information based on the document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are established by the ISO 20795-1 standard for denture base polymers. The reported device performance is compared against the minimums/maximums set by this standard.

Heat-Cure Acrylics (Basis, Basis HI, Basis Twin Cure):

Self-Cure Acrylics (Basis Flow, Re-Fine Bright):

Summary of Device Performance: The document explicitly states: "All Physical Properties within specification" for both heat-cure and self-cure acrylics, and "All Physical Properties within specification" (duplicate entry) for self-cure acrylics. This indicates that the subject devices (Yamahachi Denture Base Resins) met all the specified acceptance criteria from ISO 20795-1.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes used for each physical property test. It refers to "Bench tests were performed on the subject device in conformity with ISO 20795-1." This standard would dictate the required sample sizes for each test.
• Data Provenance: The device manufacturer is Yamahachi Dental Manufacturing Co. in Japan. The testing was conducted in conformity with ISO 20795-1, which is an international standard. The specific country where the bench tests were performed is not explicitly stated, but it can be inferred to be associated with the manufacturer or a certified testing facility accredited to ISO standards. The tests are non-clinical bench tests, not clinical studies, so the terms "retrospective or prospective" do not directly apply in the same way they would for patient data. These are laboratory measurements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for the performance of these materials is established by the ISO 20795-1 standard, which defines standardized test methods and acceptance values for physical and chemical properties of denture base polymers. These are objective measurements determined in a laboratory setting, not subjective interpretations by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews where there is subjective assessment or disagreement amongst human readers. The tests performed are objective, standardized physical property measurements.

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

This question is not applicable. This device is a denture base resin, not an AI-powered diagnostic or assistive medical device. No human readers or AI assistance are involved in its intended use or performance evaluation as described.

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

This question is not applicable. This device is a physical material (resin), not an algorithm or software.

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

The "ground truth" for the performance criteria is defined by the ISO 20795-1 international standard for denture base polymers. This standard specifies scientifically validated benchmarks and test methodologies for physical properties like flexural strength, flexural modulus, impact resistance, residual monomer, sorption, and solubility. These are objective, measurable physical and chemical properties, not subjective assessments.

8. The sample size for the training set

This question is not applicable. This device is a physical material, not an AI/ML model that requires a training set. The term "training set" is relevant to machine learning, not the testing of physical properties of denture resins.

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

This question is not applicable for the reasons mentioned in point 8.

Ask a specific question about this device