(141 days)
"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (aligners) that apply gentle pressure to teeth, gradually moving them into alignment.
A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to Nanjing Jiahe Dental Technology Co., Ltd along with the physician's prescription.
An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner travs are then manufactured by thermoforming a dental thermoplastic sheet over each model.
The "Al Smile Aligners" have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.
The provided text is a 510(k) Summary for the "Al Smile Aligner" and primarily focuses on demonstrating substantial equivalence to a predicate device ("iSMILE"). It outlines the device's description, indications for use, and a comparison with the predicate.
However, the document does not contain the information requested about acceptance criteria and a study proving the device meets those criteria (e.g., performance metrics like sensitivity, specificity, or accuracy for an AI-powered diagnostic device). The "Summary of Device Testing" section mentions "nonclinical performance tests" and "Laboratory Testing" (physical, chemical, mechanical properties, process validation, and mechanical property/elasticity according to ASTM standards), but these are related to the physical properties and manufacturing of the aligners, not the performance of an AI component in a diagnostic or treatment planning context as might be expected for an "AI Smile Aligner" if the "AI" referred to a diagnostic algorithm.
Given the context of "Al Smile Aligner" being aligners for orthodontic treatment and the description of the design process involving FDA-cleared dental software, it appears the "AI" in the device name might refer to the software used to design the aligners, rather than an AI performing a diagnostic task. The document specifically states: "An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription." This implies the AI/software is an internal design tool, and the focus of the 510(k) is on the physical aligner product's substantial equivalence.
Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance) are not applicable or not present in this type of 510(k) submission for a physical medical device (orthodontic aligners). The information provided focuses on the physical and material properties, and manufacturing process of the aligners themselves, not the clinical performance of an AI diagnostic or planning algorithm that is directly assisting a human.
Here's a breakdown of the requested information based on the provided text, indicating what is present and what is absent/not applicable:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not describe acceptance criteria for AI performance in terms of diagnostic metrics (e.g., sensitivity, specificity, accuracy). It mentions mechanical and material testing according to ASTM standards and ISO 10993 for biocompatibility, implying those standards serve as "acceptance criteria" for the physical product, but no specific numerical performance is reported in a table format for those tests. The claim is that the device "meets all the requirements" and confirms "design output meets design inputs and specifications."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not present. There is no "test set" described for evaluating AI performance in a clinical context. The tests performed are laboratory tests on the physical aligners.
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/Not present. No clinical AI evaluation or ground truth establishment is described. The "ground truth" for the aligners is the doctor's prescription and the physical/material specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present.
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/Not present. This is not an AI diagnostic device for which human reader improvement would be measured. The AI is described as "FDA cleared dental software" used internally for design, not for direct clinical decision support provided to users of the "Al Smile Aligner" product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not present. As above, the AI is not presented as a standalone diagnostic or clinical decision-making algorithm that the product's 510(k) seeks to clear for direct clinical use. It's a tool in the manufacturing process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for the physical aligner production seems to be adherence to the dental clinician's prescription and established engineering/biocompatibility standards.
8. The sample size for the training set
- Not applicable/Not present. No information about a training set for an AI algorithm is provided.
9. How the ground truth for the training set was established
- Not applicable/Not present.
Summary of what is covered in the document regarding "device performance":
The document focuses on the substantial equivalence of the physical aligner product to a predicate device. The "Summary of Device Testing" section mentions:
- Performance (physical, chemical, mechanical properties): The device "meets all the requirements for overall design... and performance results confirming that the design output meets the design inputs and specifications for the device."
- Process Validation: Validate the processes used for the design and manufacture of the customized aligners.
- Mechanical Properties & Elasticity: Studied following ASTM standards (ASTM D570, ASTM D638, ASTM D790, and ASTM D1525).
- Biocompatibility: Tested according to Good Laboratory Practices and ISO 10993 (Parts 3, 5, 10, 11). The device "Meet ISO 10993-1."
- Bench Testing and Process Validation: "Bench Testing and Process Validation" is listed in the comparison table as part of performance and is stated to be met by both the subject and predicate devices.
The "AI" in "Al Smile Aligner" refers to the software used for the design of the aligners, which is described as "An FDA cleared dental software used for teeth alignment." The 510(k) is for the physical aligner product itself, not for the "AI" software as a separate, new clinical decision support or diagnostic device. As such, the performance evaluation is centered on the physical attributes and manufacturing processes of the aligners, not on the clinical performance of an AI algorithm in a test set.
§ 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.