(157 days)
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.
This document is a 510(k) premarket notification for a medical device called "Denture Base Polymers." It's a submission to the FDA (U.S. Food & Drug Administration) to demonstrate that the device is "substantially equivalent" to legally marketed predicate devices, meaning it's as safe and effective as a device already on the market.
However, the provided text does not describe a study involving "acceptance criteria" and "device performance" in the context of an AI/algorithm-based diagnostic or prognostic device. It's for a dental material (denture base polymers), which is a physical product, not a software or AI device.
Therefore, I cannot extract the information required for your request, such as a table of acceptance criteria for AI performance, sample sizes for test sets in an AI study, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Chemical composition of the denture material.
- Technological characteristics (e.g., heat curing, self-curing).
- Physical and chemical properties that meet ISO standards (ISO 20795-1 for Dental base material).
- Biocompatibility testing (following ISO 10993 standards) to ensure it's safe for use in the human body.
- Comparison to predicate devices to demonstrate substantial equivalence for its intended use (fabrication and repair of partial and full denture base).
It explicitly states: "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies in the sense of a performance study for an AI device were conducted or are being reported here.
§ 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.