(102 days)
Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).
Orthodontic Acrylic is a fast curing self-cure 2-part system. The system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.
The provided document is a 510(k) premarket notification for an orthodontic acrylic device. It does not contain any information about an AI/ML powered device, a comparative effectiveness study, or details about ground truth establishment with experts. The document focuses on the substantial equivalence of the Orthodontic Acrylic to a predicate device based on chemical composition and physical/mechanical properties.
Therefore, many of the requested sections regarding AI/ML powered devices, expert adjudication, and ground truth establishment cannot be answered from the provided text.
Here's a breakdown of the information that can be extracted, acknowledging the limitations for AI/ML related questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance data in terms of physical/mechanical properties and biocompatibility. It does not explicitly state "acceptance criteria" with numerical targets, but rather mentions "meeting the requirements" or providing "similar" results to the predicate.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical Properties | Demonstrates similarity to the predicate device per ISO 20795-2:2010. | Tested for flexural strength, flexural modulus, fracture toughness, water sorption, and water solubility. The information provided demonstrates that they are similar to the predicate. (Specific values are not provided in this summary but are referenced as being in the 510(k)). |
| Biocompatibility | Meets requirements of ISO 7405:2008 and ISO 10993-1. | Orthodontic Acrylic was tested for Guinea Pig Maximization Sensitization Testing and Oral Mucosal Irritation (ISO 10993-10) and cytotoxicity (ISO 10993-5); Orthodontic Acrylic met the requirements for these tests. |
| In-vitro Testing | Not explicitly stated as acceptance criteria. | In-vitro testing was conducted on Candida albicans, Streptococcus mutans, and Actinomyces naselundii. (Results or specific criteria for these tests are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document refers to "in-vitro testing" and "biocompatibility testing" but does not give sample sizes for these tests.
- Data Provenance: Not explicitly stated but implied to be laboratory testing ("tested in the lab") for physical/mechanical properties and in-vitro/in-vivo animal testing for biocompatibility. There is no information regarding country of origin for the data (beyond the applicant being in Illinois, USA) or if it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes the evaluation of a dental material, not an AI/ML device that would require expert-established ground truth from medical images or clinical data. The "ground truth" for this device comes from standardized chemical, physical, and biological tests.
4. Adjudication method for the test set
- Not Applicable. As above, no expert adjudication is mentioned or relevant for this type of device evaluation.
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
- No. This document is for a dental material, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This document is for a dental material. There is no algorithm discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established through objective, standardized laboratory measurements of physical/mechanical properties (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) against established international standards (ISO). For the in-vitro testing, the ground truth would be the observed bacterial/fungal growth or inhibition under controlled lab conditions.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, so there is no "training set."
§ 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.