(98 days)
Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: - dental prosthesis - partial prosthesis - clasp prosthesis -
Major.base 20 is a denture base, poly(methyl methacrylate)-based polymers for dental prosthesis. It can be used for: - Total prosthesis . - Partial prosthesis . - Clasp dentures e Major base 20 is a heat cure denture base material composed of a poly-methylmethacrylate polymer powder and a liquid consisting of methylmethacrylate and other ingredients solution.
The provided document describes the 510(k) premarket notification for Major.base 20, a denture base material. The submission relies on substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the typical sense of a diagnostic or therapeutic device. Therefore, some of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of an algorithm or diagnostic performance, is not directly applicable or available in the provided text.
However, I can extract information related to the device's technical specifications and how its performance was assessed in the context of demonstrating substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (for Substantial Equivalence)
The acceptance criteria for Major.base 20 are implicitly defined by its substantial equivalence to predicate devices (Paladon® 65 and Probase Hot) and compliance with relevant ISO/ADA standards. The "device performance" reported is based on technical data of the polymerized material.
| Acceptance Criteria (Standard / Predicate Equivalence) | Reported Device Performance (Major.base 20) |
|---|---|
| Compliance with ISO 1567:1999 or ADA/ANSI 12:2002 (Adoption of the ISO 1567:1999) for denture relining, repairing, or rebasing resin. | "Major base 20 has the same technological characteristics as the predicate devices since all the devices are complying with ISO 1567:1999 or ADA/ANSI 12:2002 (Adoption of the ISO 1567:1999)" |
| Specific Technical Parameters (Implied from Predicate/Standard Compliance): | |
| Flexural strength (no specific numerical criterion given, but implied to be comparable to predicates/standard) | 78 MPa |
| Flexural modulus (no specific numerical criterion given, but implied to be comparable to predicates/standard) | 2390 MPa |
| Water absorption (no specific numerical criterion given, but implied to be comparable to predicates/standard) | 22.0 µg/mm³ |
| Water solubility (no specific numerical criterion given, but implied to be comparable to predicates/standard) | 1.5 µg/mm³ |
| Residual monomer (no specific numerical criterion given, but implied to be comparable to predicates/standard) | 1.8 % |
| Same intended use as predicate devices. | "Same intended use" |
| Same polymers composition as predicate devices. | "Same polymers composition" |
| Same working technique as predicate devices. | "Same working technique" |
| Historically established safety and effectiveness (demonstrated by widespread use of similar product types over 50 years). | "inherently safe when used according to the instructions for use." "50 years history of clinical research, testing and literature" without records of human incompatibility or adverse effects. |
Study Information (Based on the 510(k) Submission)
For this type of device (denture base material), the "study" is primarily a nonclinical testing and comparison to existing, legally marketed predicate devices and reliance on extensive historical data and scientific literature.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a diagnostic AI study. The technical data provided (Flexural strength, modulus, water absorption, solubility, residual monomer) are physical properties measured on the material itself. The document does not specify the number of samples used for these tests.
- Data Provenance: The technical tests were "performed by NIOM Laboratory - Norway." The broader "data" for substantial equivalence relies on a vast body of dental literature and historical clinical experience over 50 years worldwide ("universal in the last fifty years manufacturing and clinical experience").
-
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)
- Not applicable. This device is a material, not one requiring expert human interpretation for ground truth or diagnostic assessment. The "ground truth" for the material's properties would be defined by the standardized testing protocols themselves.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a diagnostic interpretation scenario requiring adjudication.
-
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
- Not applicable. This is not an AI-assisted diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the reported performance metrics (flexural strength, etc.) is the results of standardized laboratory physical property testing.
- For the overall safety and effectiveness claim, the "ground truth" is established through extensive scientific literature, historical clinical experience (over 50 years with similar products), and compliance with international standards (ISO 1567:1999 / ADA/ANSI 12:2002), along with a lack of adverse event records from the manufacturer's long history.
-
The sample size for the training set
- Not applicable. This is not a machine learning device that requires a "training set."
-
How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.