(314 days)
Illusion Aligners Pro are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
A dental health professional (e.g., an orthodontist or a dentist) prescribes the Illusion Aligners Pro and Illusion Aligner Flx are based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes either the intraoral scans or physical impressions of the patient's teeth, determines the required corrections to align the teeth, and 3Shape's Ortho System is used for treatment planning. Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances 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 aligners are to be removed for eating and for cleaning. Illusion Aligners Pro and Illusion Aligner Flx are fabricated using a three- step process.
The first step is to obtain the dimensions and details of the patient's dentition. This is generally done using an intraoral scan or a physical impression. This scanned data (digital CAD/CAM models or patient models) is 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, Illusion Aligners Pro and Illusion Aligner Flx 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 models 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 standard thermoforming equipment and the appropriate material as specified. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished, and treatment is complete
The provided text is a 510(k) Summary for the devices Illusion Aligner Pro and Illusion Aligner Flx. It details the safety and effectiveness assessment based on substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.
Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set information are not present in this document.
The document explicitly states: "No clinical study was conducted." This is a key piece of information that means the device's performance was not evaluated through clinical trials or comparative effectiveness studies described in points 2-7 of your request.
Here's a breakdown of the available information based on your request, highlighting what is not provided:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The acceptance is based on demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: No quantitative performance data is present as no clinical or comparative performance study was conducted. The "performance tests" mentioned are likely non-clinical (e.g., material properties, dimensional accuracy relative to the manufacturing process), but specific metrics are not detailed.
The comparison tables (Table-1 and Table-2) focus on technological characteristics and intended use alignment with predicate devices, not on quantifiable performance metrics of the subject devices themselves.
2. Sample size used for the test set and the data provenance:
- Not provided. No test set or data provenance from a performance study is mentioned, as no clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or associated ground truth established by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is mentioned.
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:
- No MRMC study was done. This device is an orthodontic aligner, not an AI-assisted diagnostic tool for human readers. The document explicitly states, "No clinical study was conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a physical medical device (aligner), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No ground truth for a performance study is mentioned.
8. The sample size for the training set:
- Not applicable/Not provided. This document describes a physical medical device (aligner) requiring traditional substantial equivalence demonstration, not a machine learning model that would have a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, this concept does not apply to the type of device and submission described.
Summary of what the document does provide regarding acceptance and proof:
The acceptance criteria and proof of safety and effectiveness for Illusion Aligner Pro and Illusion Aligner Flx derive from demonstrating Substantial Equivalence (SE) to legally marketed predicate devices, as per the FDA 510(k) pathway.
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Acceptance Criteria (Implicit via Substantial Equivalence):
- Same Indications for Use: The subject devices align with the predicate devices in their indication for "alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion."
- Similar Technological Characteristics: The devices share fundamental design principles and mode of action (applying continuous gentle force for tooth movement).
- Equivalent Materials: Illusion Aligner Pro uses polyurethane, matching its predicate DailyMate. Illusion Aligner Flx uses co-polyester and polyurethane composite, matching its predicate Smylio Invisible Clear Aligners.
- Biocompatibility: The devices must meet ISO 10993 standards for permanent tissue-contacting mucosal membrane devices (contact > 30 days).
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Study Proving Acceptance (Method of Proof):
- The primary method of proof is comparison to predicate devices and non-clinical testing.
- Biocompatibility Testing: The devices were evaluated for:
- In Vitro Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2021)
- Intracutaneous Reactivity (ISO 10993-23:2021)
- Performance Tests: General statement that "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." However, no specific metrics or data from these tests are provided in this summary. These tests likely relate to physical properties and manufacturing quality control rather than clinical outcomes.
- Animal Study: The conclusion mentions "animal study provided in this submission," but no details of such a study are present in the extract provided.
- No Clinical Study: Explicitly stated, "No clinical study was conducted."
In essence, the "proof" is that the new devices are sufficiently similar to already legally marketed devices in terms of materials, intended use, and fundamental mode of action, and they meet relevant non-clinical safety standards (biocompatibility). The FDA assumes that if these similarities hold, the new device is as safe and effective as the predicate.
§ 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.