(308 days)
Vivid Aligner is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
Orthodent Laboratory, Inc. Vivid Aligner are intraoral thermoformed plastic aligner that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner are to be removed for eating and for cleaning. Orthodent Laboratory, Inc. Vivid Aligner are fabricated using a three-step process. The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Orthodent Laboratory utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.
This document describes the 510(k) premarket notification for the Vivid Aligner by Orthodent Laboratory, Inc. This submission seeks to establish substantial equivalence to existing legally marketed devices, rather than proving a new device's performance against specific acceptance criteria for a novel technology.
Therefore, many of the requested details regarding acceptance criteria, specific study design for device performance (especially for AI/algorithmic components), and clinical efficacy studies are not applicable to this type of submission. This document primarily focuses on demonstrating that the Vivid Aligner is similar enough to predicate devices in terms of materials, intended use, and general manufacturing process to be considered safe and effective.
Here's an breakdown of the available information based on your request, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not applicable in this context. The submission's goal is to demonstrate "substantial equivalence" to predicate devices, not to meet specific performance metrics for a novel AI or algorithmic device. The "device performance" here is primarily tied to material properties and biocompatibility, not an AI's diagnostic or therapeutic accuracy.
The document states the following device testing:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993 standards: Part 3 (Bacterial Mutagenicity – Ames Assay), Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal Reactivity), Part 10 (Oral Mucosa Irritation), Part 10 (Maximization for Delayed-Type Hypersensitivity), Part 11 (Subacute Systemic Toxicity). |
| Non-Clinical Physical Properties | Device material tested to and meets acceptance criteria for: |
| • Elongation @ Yield (%) ASTM D638 | |
| • Elongation @ Break (%) ASTM D638 | |
| • Tensile @ Yield (PSI) ASTM D638 | |
| • Tensile Strength (PSI) ASTM D638 | |
| • Tensile Modulus (PSI) ASTM D638 | |
| • Flexural Modulus (PSI) ASTM D790 | |
| • Flexural Strength (PSI) ASTM D790 | |
| • Specific Gravity g.cm3 ASTM D792 | |
| • Water Absorption (%) 24 hours @ 23°C ASTM D570 | |
| • Gardner Impact Strength 23°C J/mm ASTM D5420 |
2. Sample size used for the test set and the data provenance
This information is not provided as there wasn't a "test set" in the context of an AI/algorithmic device performance study. The tests conducted were material property and biocompatibility tests, which would have their own sample sizes for the materials themselves, but these are not disclosed.
- Data Provenance: N/A (for AI performance). For material testing, it would be lab-generated data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic AI systems. This submission is for orthodontic aligners, where performance is measured by material properties and biocompatibility, not diagnostic accuracy requiring expert panel review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies involving human interpretation or performance evaluation of AI systems.
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
This is not applicable. MRMC studies are relevant for diagnostic devices that assist human readers. The Vivid Aligner is a physical orthodontic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for the device's primary function. While the device manufacturing involves software (3Shape Software K180491), the submission does not describe standalone performance testing of this software in isolation as if it were a diagnostic AI. The software's role is in treatment planning and model generation for the physical aligners. The submission notes the software is "FDA 510K cleared" and its "use/manufacturing process has been validated by ODL."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable in the context of diagnostic AI ground truth. For the material testing, the "ground truth" would be established by the standardized test methods (e.g., ASTM, ISO standards) and their defined acceptance criteria for material properties. For biocompatibility, the ground truth is adherence to ISO 10993 testing protocols and passing results.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set for an algorithm.
Summary of Device Acceptance / Substantial Equivalence:
The core of this 510(k) submission for the Vivid Aligner is to demonstrate substantial equivalence to existing predicate devices (K173784 Smylio Invisible Clear Aligner, K173785 Derby Dental, Custom Clear Aligner System, and K182826 Ormco Spark Aligner System).
The "study that proves the device meets the acceptance criteria" (in the context of a 510(k) for this type of device) consisted of:
- Biocompatibility Testing: The device's materials were tested according to ISO 10993 standards (Parts 3, 5, 10, 11) and found to be biocompatible. This is a critical "acceptance criterion" for any medical device coming into contact with the patient.
- Non-Clinical Physical Properties Testing: The device material was tested against various ASTM standards for properties like elongation, tensile strength, flexural modulus, specific gravity, water absorption, and impact strength, and met the predefined "acceptance criteria" for these material parameters (actual pass/fail thresholds are not detailed in the summary, but it states they "meet the acceptance criteria").
- Comparison to Predicate Devices: A detailed comparison table (pages 4-6) was provided to show that:
- The Indications for Use are identical to the predicate.
- The Mode of Action is the same.
- The Method of Use is the same.
- The Material (thin thermoformed polyurethane) is the same.
- It is Biocompatible (as demonstrated by testing).
- It is a Prescription Use device, similar to the predicate.
- It uses Software, and the software used (3Shape K180491) is also FDA 510(k) cleared.
- It is Non-Sterile, like the predicate.
- Minor differences (Orthodent prepares treatment plan vs. doctor, specific 3Shape software version, specific ISO standard citation for biocompatibility) were assessed and deemed to "not affect substantial equivalence or safety and effectiveness."
Conclusion from the Document:
Based on the material testing and the demonstration of substantial equivalence in intended use, technological characteristics, and performance to the predicate devices, the FDA determined that the Vivid Aligner is "substantially equivalent" and may be legally marketed. This process does not involve the in-depth AI-specific performance studies envisioned in many of your questions.
§ 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.