(129 days)
DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.
DynaFlex ® Clear Brackets & Buttons is a series of clear, lightweight, ceramic brackets, and buttons. DynaFlex ® Clear Brackets & Buttons are used in the alignment of teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
DynaFlex ® Clear Brackets & Buttons are designed to move teeth to improve their alignment. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic brackets are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Bonding supplies are used to bond the bracket on to a tooth. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Bracket & Buttons is for prescription only.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device performance study. The document is a 510(k) summary for DynaFlex Clear Brackets & Buttons, which are orthodontic physical devices, not an AI/ML software.
The document discusses performance characteristics based on bench testing for bond strength and other non-clinical performance tests for overall design, biocompatibility, and manufacturing process validation. It then establishes substantial equivalence to a predicate device (Carriere SLX 3D Clear) based on similar design, materials, manufacturing methods, intended use, and similar technological characteristics.
Therefore, many of the requested elements pertaining to AI/ML device performance studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable or available in this document.
However, I can extract the relevant information regarding the performance characteristics and the non-clinical testing performed to establish substantial equivalence for this specific medical device.
Here's the information derived from the provided text, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from predicate or internal requirements) | Reported Device Performance |
|---|---|---|
| Minimum Bond Strength (N/MPa) | Predicate: 103.7 / 7.63 (implied as benchmark for "within range") | 80 / 6.0 (Met minimum specification) |
| In/Out (dimension) | Predicate: .025" - .046" | .027" - .039" (Within range of predicate) |
| Torque (dimension) | Predicate: -17° through +17° | -12° through +12° (Within range of predicate) |
| Angulation (dimension) | Predicate: Up to +9° | Up to +9° (Within range of predicate) |
| Rotation (dimension) | Predicate: Up to +12° | Up to +5° (Within range of predicate) |
| Biocompatibility | ISO 10993-1 and its applicable parts | Passed ISO 10993-1 and series |
| Manufacturing Process Flow Validation | Specifications of technical requirements | Met specifications |
| Overall Design Performance | Design inputs and specifications | Met design inputs and specifications |
2. Sample size used for the test set and the data provenance
- Bond Strength Testing: "all samples tested" (specific number not provided).
- Other Non-Clinical Testing: Not specified.
- Data Provenance: Not specified, but generally, bench test data is generated in-house by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not an AI/ML device performance study requiring expert ground truth for image/data interpretation. Performance is based on physical property measurements and adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Performance is based on direct measurement against defined physical or material standards, not interpretive human judgments.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used
- For bond strength: Quantitative measurement of physical breaking point against a specified minimum.
- For other properties (In/Out, Torque, Angulation, Rotation): Quantitative measurement of dimensions and angles against a specified range (derived from the predicate device).
- For biocompatibility: Compliance with ISO 10993 series through laboratory testing.
- For manufacturing process: Adherence to internal technical specifications and standards.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as 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.