(225 days)
The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.
Composite brackets provide a clear, aesthetic option for patients undergoing orthodontic treatment. The Composite Bracket system is designed to provide simple, aesthetic bonded brackets to correct minor to complicated mal-alignments in patients with permanent dentition (second molars) or mixed dentition using current orthodontic diagnosing techniques with orthodontic arch wires. The system consists of a series of clear, plastic brackets that conform to each tooth and its anatomy and adheres with a bracket base bearing a mechanical retention surface. They are provided with or without a metal archwire slot. Additional accessories to the brackets, depending on the dental professionals' technique, mav include small hooks for the use of elastics and auxiliary arch wire tubes. Each bracket applies incremental, progressive force to reposition teeth to achieve ideal alignment, as prescribed by the treating dental practitioner. The composite brackets are bonded to the patient's teeth by traditional orthodontic direct and indirect bonding techniques using Orthodontic adhesives.
The provided text describes a 510(k) premarket notification for "Composite Brackets" by Ortho Specialties, Incorporated. This document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML-driven device with acceptance criteria and a study proving performance against those criteria in the typical sense of AI model evaluation.
Therefore, many of the requested sections about AI study specifics cannot be answered from the provided text. I will extract the information that is present.
This document is a 510(k) premarket notification for a medical device called "Composite Brackets." It is a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study evaluating the performance of an AI/ML algorithm. As such, the typical acceptance criteria and study design for AI models (e.g., sensitivity, specificity, ROC curves, human reader improvement) are not applicable here.
However, I can extract information related to the device's characteristics and the biological evaluation studies performed for regulatory clearance.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML algorithm evaluation, there are no "acceptance criteria" in the traditional sense of performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the biological safety tests and the claim of substantial equivalence to predicate devices based on technological characteristics.
| Property | Acceptance Criteria (Implied) | Reported Device Performance (Composite Brackets) |
|---|---|---|
| Cytotoxicity (ISO 10993-5 Elution Method) | No evidence of cell lysis or toxicity, grade less than 2 | Showed no evidence of causing cell lysis or toxicity; met requirements with a grade of less than 2 (Mild reactivity). |
| Oral Mucosal Irritation (ISO 10993-10) | Considered a non-irritant to oral mucosa | Considered a nonirritant to the oral mucosa of the hamster. |
| Technological Equivalence | Similar intended use, composition, aesthetics, physical properties, application, and manufacturing method to predicate devices (Dentsply Elation MB and CDB Reflections) | Demonstrated similar intended use, composition (Polycarbonate), aesthetic features (Clear/translucent), mode of use (Archwire implementation), application (Bonded), and manufacturing method (Molded, thermo-formed). |
| Physical Properties | Similar shear bond and compressive strength to predicate devices | Physical property testing showed similar shear bond and compressive strength to predicate devices. (Specific values not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cytotoxicity Test: The ISO 10993-5 Elution Method involves in vitro mammalian cell culture. The sample size refers to the number of cell cultures or replicates tested, which is not specified but follows ISO guidelines. Data provenance is implied by adherence to ISO standards.
- Oral Mucosal Irritation Test: Performed in hamsters. The number of hamsters (sample size) is not specified but follows ISO 10993-10 guidelines. Data provenance is implied by adherence to ISO standards.
- Technological Equivalence Comparison: This is a comparison of device characteristics against predicate devices, not a test with a "test set" of patient data.
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)
Not applicable to this type of device and study. The "ground truth" for the biological evaluations is determined by the standardized test methods outlined in the ISO standards. The evaluation of technological equivalence is a comparison of product specifications by regulatory professionals and engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The biological tests follow standardized laboratory protocols. The comparison to predicate devices is a regulatory assessment.
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 document is for an orthodontic bracket, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cytotoxicity: The "ground truth" is defined by the cellular response to the eluted materials as per ISO 10993-5 (e.g., cell viability, morphological changes indicating toxicity).
- Oral Mucosal Irritation: The "ground truth" is based on observed inflammatory responses in the hamster oral mucosa as per ISO 10993-10 (e.g., erythema, edema).
- Technological Equivalence: The "ground truth" for comparison is the documented characteristics and performance of the legally marketed predicate devices.
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. There is no training set for this 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.