(101 days)
The Straight T Clear Dental Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
A dental health professional (e.g. orthodontist or dentist) prescribes the Straight T Dental Aligners based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. Straight T Clear Dental Aligner are intraoral thermoformed plastic aligners that are worn 20 to 21 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. Straight T Clear Dental Aligners 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, Straight T Dental 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. 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 describes a 510(k) summary for the Straight T Clear Dental Aligner, focusing on demonstrating substantial equivalence to a predicate device (Smylio Invisible Clear Aligners K173784). It primarily presents non-clinical testing for material properties and biocompatibility rather than a study on device performance in terms of its intended use (teeth alignment).
Therefore, there is no information in the provided text to answer most of the questions regarding device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The device itself is a physical aligner, not an AI or imaging device, so many of these questions are not applicable in this context.
However, I can extract the acceptance criteria for material properties and the type of ground truth used for biocompatibility.
Here's a breakdown of what can be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists physical and biocompatibility tests. For physical properties, the acceptance criteria are not explicitly stated as numerical targets but rather that the material "meet the criteria" of the listed ASTM standards. For biocompatibility, the acceptance criteria are implicit in passing the ISO 10993 tests.
| Test Category | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Part 3 (Bacterial Mutagenicity) | Pass (non-mutagenic) | Passed |
| Part 5 (Cytotoxicity Elution) | Pass (non-cytotoxic) | Passed | |
| Part 10 (Intracutaneous Reactivity) | Pass (non-irritating) | Passed | |
| Part 10 (Oral Mucosa Irritation) | Pass (non-irritating) | Passed | |
| Part 10 (Maximization for Delayed-Type Hypersensitivity) | Pass (non-sensitizing) | Passed | |
| Part 11 (Subacute Systemic Toxicity) | Pass (non-toxic) | Passed | |
| Physical Properties | Elongation @ Yield (%) ASTM D638 | Meet ASTM D638 criteria | Met criteria |
| Elongation @ Break (%) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile @ Yield (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile Strength (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile Modulus (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Flexural Modulus (PSI) ASTM D790 | Meet ASTM D790 criteria | Met criteria | |
| Flexural Strength (PSI) ASTM D790 | Meet ASTM D790 criteria | Met criteria | |
| Specific Gravity g.cm3 ASTM D792 | Meet ASTM D792 criteria | Met criteria | |
| Water Absorption (%) 24 hrs @ 23°C ASTM D570 | Meet ASTM D570 criteria | Met criteria | |
| Gardner Impact Strength 23°C J/mm ASTM D5420 | Meet ASTM D5420 criteria | Met criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the physical or biocompatibility tests. It also does not provide information on data provenance (country, retrospective/prospective).
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. The tests performed are laboratory tests for material properties and biocompatibility, not clinical studies requiring expert ground truth for outcome assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical outcomes.
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 device is a physical dental aligner, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental aligner, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" is established by the standardized methods and results of the ISO 10993 tests themselves, which determine toxicity, mutagenicity, irritation, etc. These are objective laboratory measurements against established biological standards.
For physical properties, the "ground truth" is the measured values of the material properties as determined by the specified ASTM standards. These are objective, quantifiable measurements.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.