(225 days)
Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.
The provided document is a 510(k) premarket notification for "Ceramic Brackets Orthometric". It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.
However, I can extract information related to the performance tests conducted to demonstrate equivalence for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes performance tests carried out to prove the technical equivalence to the predicate device. The comparison table (Table 5.1) focuses on equivalence of characteristics rather than specific performance metrics and acceptance thresholds.
Based on the text: "Performance tests were carried out to prove the technical equivalence between the Orthometric's Ceramic Brackets and the predicate Clarity Advanced Ceramic Brackets (K102803)."
And the findings:
- "The data demonstrates the similarity of the dimensional characteristics when compared."
- "The results of adhesion strength tests demonstrate that both products had similar behavior, showing equivalence, both in the measurement of the external force necessary for detachment and in the shear stress."
- "The Orthometric's Ceramic Brackets demonstrated similarity in the friction resistance test."
A summary table for performance could be constructed as follows, with the understanding that "acceptance criteria" here is implicitly "demonstrate similarity/equivalence to the predicate":
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Orthometric Ceramic Brackets) |
|---|---|---|
| Dimensional Characteristics | Demonstrate similarity to predicate | Data demonstrates similarity when compared to predicate. |
| Adhesion Strength | Demonstrate similar behavior to predicate | Similar behavior to predicate in external force for detachment and shear stress. |
| Friction Resistance | Demonstrate similarity to predicate | Demonstrated similarity in the friction resistance test compared to predicate. |
| Biocompatibility | Meet applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for the performance tests (dimensional characteristics, adhesion strength, friction resistance). It also does not mention data provenance (country of origin, retrospective/prospective) for these non-clinical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. This document describes material and mechanical property equivalence.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device requiring adjudication.
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
Not applicable. This is not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The type of ground truth used
Not applicable in the context of expert-derived ground truth for an AI/ML device. For this device, "ground truth" would refer to established physical and material properties (e.g., actual dimensions measured by instruments, measured forces, biological reactions to materials as per ISO standards).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.