(56 days)
Clear Miracle is a clear orthodontic appliance designed to treat malocclusions in patients with permanent dentition (i.e., all second molars). It uses a series of gradual tooth movements to position teeth sequentially with continuous gentle force. Clear Miracle is intended for professional use only.
Clear Miracle is a methacrylate-based resin designed for creating clear, light-cured aligners. It is supplied in 250-gram bottles made of high-density polyethylene (HDPE) and is a light yellow in color. Exposure to ultraviolet (UV) light within the 405–412-nanometer (nm) wavelength range causes the liquid resin to solidify into a three-dimensional structure. The resin contains a photoinitiator that begins the curing process at wavelengths between 405 and 412 nm. During additive manufacturing, Clear Miracle forms 50-μm-thick layers, achieving a resolution of 0.022 mm in the X and Y axes. This ensures the creation of high-precision orthodontic aligners through a layer-by-layer curing process.
This document is a 510(k) Clearance Letter from the FDA for a medical device called "Clear Miracle," an orthodontic clear aligner. According to the document, clinical testing was not required for this device due to its substantial equivalence to a predicate device. Therefore, the provided text does not contain information about explicit acceptance criteria for device performance based on a study, a test set, expert involvement, or any human-in-the-loop (MRMC) or standalone algorithm performance studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (TERA HARZ CLEAR, K223355) through non-clinical testing and comparison of technological characteristics.
Here's a breakdown of the information that can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a clinical study that the device must meet to prove its efficacy/safety in real-world scenarios. Instead, it reports performance values obtained from non-clinical mechanical property tests and compares them to the predicate device's values and relevant ISO standards. The implicit "acceptance criteria" here are that the 'Clear Miracle' device performs at least as well as the predicate device or meets the relevant ISO standard requirements.
| Characteristic / Test | Acceptance Criteria (Implicit / From Standard) | Reported Device Performance (Clear Miracle) | Predicate Device (TERA HARZ CLEAR) | Difference |
|---|---|---|---|---|
| Ultimate Flexural Strength | ≥50 MPa (ISO 20795-2:2013) | Min. 99 to Max. 105 MPa | Min. 62 to Max. 67 MPa | Superior |
| Flexural Modulus | ≥1500 MPa (ISO 20795-2:2013) | Min. 1,629 to Max. 1924 MPa | Min. 1,545 to Max. 1,595 MPa | Superior |
| Residual Methyl Methacrylate Monomer | Implied: 0% (as per predicate) | 0% | 0% | No difference |
| Solubility | ≤5 μg/mm³ (as per standard / predicate) | Min. 0 to Max. 1.0 μg/mm³ | Min. 1.5 to Max. 2.1 μg/mm³ | Superior (lower is better for solubility) |
| Water Sorption | ≤32 μg/mm³ (as per standard / predicate) | Min. 14.0 to Max. 17.0 μg/mm³ | Min. 13.0 to Max. 14.8 μg/mm³ | Difference (slightly higher, but within standard) |
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatible | Biocompatible | No difference |
| Appearance, Weight, Surface Characteristics, Color, Porosity | Smooth surface, high gloss, matched color, no porosity | Met expectations | Met expectations | No difference |
| Dimensional Accuracy (via Validation) | within ±0.150 mm | Within ±0.150 mm | N/A (Process validation for Clear Miracle) | N/A |
2. Sample size used for the test set and the data provenance:
- Test Set (for performance validation): The document does not specify a "test set" in the context of patient data or clinical cases. The "testing" referred to is laboratory-based non-clinical testing of materials and manufacturing processes. Therefore, information about patient sample sizes or their provenance (country, retrospective/prospective) is not applicable/provided.
- The mechanical properties tests were conducted on "specimen plates" as per ISO 20795-2:2013. The exact number of specimens tested for each characteristic is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/provided. As there was no clinical study testing the device's performance against human ground truth (e.g., diagnostic accuracy), there were no experts establishing ground truth in that sense. The "ground truth" for the non-clinical tests is based on the methods and measurements defined by the ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/provided. No adjudication method was mentioned as there was no clinical reading or expert review process involved.
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. The device "Clear Miracle" is described as a "clear orthodontic appliance" made of resin, a physical device, and not an AI/software. Therefore, no MRMC study or AI assistance evaluation would be relevant or conducted for this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. See point 5. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical mechanical property tests, the "ground truth" is established by the measurement standards and methodologies prescribed by ISO 20795-2:2013. This involves precise laboratory measurements of physical properties.
8. The sample size for the training set:
- Not applicable/provided. There is no "training set" in the context of machine learning for this physical device. The manufacturing process does involve "optimization" and "validation" of print parameters, but this is not a machine learning training process.
9. How the ground truth for the training set was established:
- Not applicable/provided. As there's no training set for an AI model, this question is not relevant.
In summary:
This FDA clearance for "Clear Miracle" is for a physical medical device (orthodontic aligner resin), not an AI/software product. The substantial equivalence determination was primarily based on non-clinical laboratory testing against well-established international standards (ISO 20795-2:2013, ISO 10993-1) and direct comparison of its material properties and manufacturing process with a previously cleared predicate device. Therefore, many of the questions related to clinical trials, AI performance, expert review, and ground truth establishment in a diagnostic context are not relevant to this specific device clearance.
§ 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.