(266 days)
The Arcad SmileStudio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The Arcad Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Arcad Aligner System positions teeth by way of continuous gentle force.
The use of the Arcad SmileStudio and Aligner System requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
The Arcad SmileStudio software is an orthodontic diagnosis and treatment simulation software for use by dental professionals. SmileStudio imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
The Arcad Aligner System is a series of customized clear plastic removable aligners that are fabricated from a clear. thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
ArcadLab manufactures the customized aligners based on either standard impressions or intraoral scans sent to the company by the prescribing dentist or orthodontist. Arcadlab manufactures models from the impressions and those models are scanned using standard validated software. The digital files are used to produce the aligner series with the thermoplastic polyurethane.
The packaged aligners are sent to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, including the predicate aligners.
Acceptance Criteria and Study for Arcad SmileStudio and Aligner System (K192244)
The provided document describes the Arcad SmileStudio and Aligner System, an orthodontic diagnosis and treatment simulation software, along with customized clear plastic aligners. The submission mainly focuses on demonstrating substantial equivalence to predicate devices for FDA clearance, rather than presenting a standalone study with detailed performance metrics and acceptance criteria for an AI component.
Based on the information provided, it's not possible to generate a table of acceptance criteria and reported device performance for an AI component with specific quantitative metrics. The document primarily focuses on the "Arcad SmileStudio software" as an "orthodontic diagnosis and treatment simulation software" and "Arcad Aligner System" as a physical aligner system. While the software provides tools for "systematic inspection, detailed analysis, treatment simulation and virtual design," the document does not mention or quantify any AI components within this software, nor does it define specific performance acceptance criteria for such components.
Therefore, the following responses are based on what can be inferred from the provided text, acknowledging the limitations in scope regarding AI-specific evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not specify quantitative acceptance criteria or detailed performance metrics for any AI components. The "device testing" section primarily mentions validation processes for design and manufacture of aligners and testing for the SmileStudio software in general, without isolating or quantifying AI performance. The overall "Substantial Equivalence Conclusion" implies that the device performs similarly to its predicates, which is a qualitative assessment for regulatory purposes rather than a detailed performance report.
Therefore, a table cannot be constructed with the requested information from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set related to the performance of the Arcad SmileStudio software (or any potential AI components within it). It only mentions "Test data were submitted to validate the processes used for the design and manufacture of the clear customized aligners" and "Testing to verify and validate the Arcad SmileStudio software was included in the premarket notification." The provenance of any such data (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for any test set, particularly concerning any software or AI performance. The "Indications for Use" statement emphasizes that "The use of the Arcad SmileStudio and Aligner System requires the user to have the necessary training and domain knowledge in the practice of orthodontics," implying expert involvement in the use of the system rather than in validating its performance with ground truth.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) for a test set is described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI assistance versus without AI assistance. The focus is on demonstrating substantial equivalence to predicate devices, not on comparative effectiveness studies involving AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document does not explicitly state whether a standalone (algorithm only) performance study was conducted. Given the description of the Arcad SmileStudio as a "medical front-end device providing tools" and emphasizing the need for user training and domain knowledge, it suggests a human-in-the-loop system rather than a purely standalone algorithm.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing of the Arcad SmileStudio software or its potential AI components. Terms like expert consensus, pathology, or outcomes data are not mentioned in relation to performance evaluation.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is consistent with the lack of explicit mention or details about AI components within the software.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth might have been established.
§ 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.