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510(k) Data Aggregation
(263 days)
DailyMate Orthodontic Aligner System
The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.
The DailyMate® Orthodontic Aligner System is a series of dental aligners fabricated of clear, plastic removable aligners are designed and custom-made by dental professionals. The aligners are made of aesthetic and medical grade materials. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them, specifically for the DailyMate Orthodontic Aligner System (K212803).
Based on the document, it's clear this is a premarket notification (510(k)) submission for an orthodontic aligner system. The review focuses on substantial equivalence to predicate devices rather than proving specific device performance criteria through clinical studies or AI algorithm validation in the way one might for a diagnostic AI device.
Therefore, the requested information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in terms of performance metrics for an AI algorithm is largely not applicable in the context of this 510(k) submission. This document describes a medical device, but not an AI/ML powered device that would have the specific types of performance studies (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts) commonly associated with AI/ML medical devices.
The acceptance criteria here are for demonstrating substantial equivalence primarily through comparison of design, materials, indications for use, and a limited set of non-clinical (bench) tests.
Despite the non-applicability to AI/ML device validation, I will extract and present the relevant information that is available in the document, framed within the lens of substantial equivalence.
Overview of "Acceptance Criteria" for K212803 (DailyMate Orthodontic Aligner System)
The "acceptance criteria" for this 510(k) submission are not defined as specific performance metrics of an AI algorithm, but rather as meeting the requirements for substantial equivalence to predicate devices. This is achieved by demonstrating comparable:
- Indications for Use
- Mechanism of Action
- Method of Use
- Method of Manufacture
- Raw Material (Biocompatibility)
- Software Use (for aligner design)
- Sterilization (or lack thereof)
- And performing specific non-clinical (bench) tests to show material equivalence.
The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission package, which includes a comparative analysis table and results from non-clinical bench testing.
Details as per the requested format:
1. A table of acceptance criteria and the reported device performance
| Criteria Area (for Substantial Equivalence) | Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance / Comparison |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate device (K182329) and reference device (K143630). | DailyMate: "treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force." |
| Predicate (SureCure): Same wording. | ||
| Reference (Invisalign): "alignment of teeth during orthodontic treatment of malocclusion." | ||
| Conclusion: "Same as the predicate device" for SureCure. (Slight difference with Invisalign's wording, but considered equivalent for treatment purpose). | ||
| Mechanism of Action | Substantially equivalent. | DailyMate: "Based on the clinician's treatment plan, each aligner is used for a defined period of time to exert gentle force to achieve progressive realignment of the teeth. This occurs over time until the final correction has been achieved." |
| Predicate (SureCure): Same wording. | ||
| Reference (Invisalign): "Sequential aligners apply continuous gentle force to the teeth." | ||
| Conclusion: "Same." (For SureCure). | ||
| Method of Use | Substantially equivalent. | DailyMate: "Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next sequential aligner tray." |
| Predicate (SureCure): Same wording. | ||
| Reference (Invisalign): "Aligners are worn for approximately 2 weeks of 20-22 hours of wear per day, after which it is replaced by the next stage aligners." | ||
| Conclusion: "Same as the predicate device." (For SureCure). | ||
| Method of Manufacture | Substantially equivalent. | DailyMate: "Using software, molds/models are 3D printed based on the treatment plan. Aligners are fabricated on the molds using a thermoforming machine." |
| Predicate (SureCure): Same wording. | ||
| Reference (Invisalign): Uses 3-D software, scans, generates images of final/intermediate states, practitioner approval, then fabrication. | ||
| Conclusion: "Same as the predicate device." (For SureCure). | ||
| Raw Material Used | Substantially equivalent/similar. | DailyMate: "Thin thermoformed polyurethane." |
| Predicate (SureCure): "Thin thermoformed polyurethane." | ||
| Reference (Invisalign): "Thin thermoformed polyurethane." | ||
| Conclusion: "Similar." | ||
| Biocompatibility | Materials must be biocompatible for intended use (mucosal membrane contact > 30 days). Tested per ISO 10993 Parts 5 (Cytotoxicity) and 10 (Sensitization, Oral Mucosa Irritation). | Results: "The testing results demonstrate that the material of DailyMate® Orthodontic Aligner System is biocompatible for the intended use." |
| Non-Clinical Bench Testing (Material) | Demonstrates equivalence in material properties. Tests included pH change, water absorption change, and tensile strength change. | Comparison: Bench tests comparing DailyMate® Orthodontic Aligner System and Invisalign System showed "substantial equivalent" results for pH change, water absorption change, and tensile strength change. |
| Software Use | Utilizes 510(k) cleared dental software for aligner design and review, similar to predicate. | DailyMate: Uses "3Shape Ortho System" (K152086). |
| Predicate (SureCure): Uses "3Shape Ortho System". | ||
| Reference (Invisalign): Uses "Invisalign System 3-D software." | ||
| Conclusion: "Same as the predicate device." (For SureCure, both use the same cleared software). | ||
| Regulatory Class/Code/Rx Status | Match predicate device. | All are Class II, Product Code NXC, Rx Use. Conclusion: Same. |
| Manufacturing Standards | Adherence to Quality System (QS) regulation / GMP standards (e.g., ISO 13485 certification). Mitigation of risks associated with customized treatment plans. | Reported: Manufacturer is "an ISO13485 certified facility which follows GMP standards during the manufacturing processes." Risks mitigated by using 510(k) regulated software and requiring certified dental practitioner approval for every treatment plan. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to is biocompatibility testing (material samples) and non-clinical bench testing (device material samples). No human patient "test set" was used for performance evaluation.
- Data Provenance: The document does not specify the country of origin for the non-clinical testing data. The biocompatibility and bench testing data would be from laboratory experiments rather than patient data. The manufacturer is 3D Global Biotech Inc. from Taiwan. The correspondent contact is in California, USA.
- Retrospective/Prospective: Not applicable, as no clinical study on patient data was performed. The non-clinical tests are prospective laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no AI/ML test set requiring expert-established ground truth. The "ground truth" equivalent for this device is the established safety and efficacy profiles of the predicate devices and the physical/chemical properties of the materials and device.
4. Adjudication method for the test set
- Not applicable. No expert adjudication was relevant or required for this type of submission.
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. An MRMC study was not performed, as this is not an AI/ML assistance device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not a standalone AI algorithm device. The device itself is the physical aligner system. The software mentioned (3Shape Ortho System) is separate, already 510(k) cleared software used in the design process of the aligners and is human-in-the-loop (dental practitioner reviews and approves).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility and material equivalence, the "ground truth" is established laboratory testing standards (e.g., ISO 10993) and the known properties/performance of the predicate device materials. There is no "truth" in the diagnostic sense (like pathology or outcomes data).
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, no ground truth needed to be established for it.
Summary regarding AI/ML related criteria:
The provided document describes a 510(k) submission for a physical medical device (orthodontic aligners). While software (3Shape Ortho System) is used in the design and manufacturing process of the aligners, the submission emphasizes that this software is already 510(k) cleared (K152086) and is used by a human dental practitioner who reviews and approves the treatment plan. Therefore, the DailyMate Orthodontic Aligner System itself is not an AI/ML-powered diagnostic or therapeutic device requiring validation studies typical for AI/ML products (e.g., MRMC, standalone algorithm performance, specialized ground truth establishment). The "acceptance criteria" and "proof" in this context are solely related to demonstrating substantial equivalence to predicate devices through design comparison, material testing, and adherence to manufacturing standards.
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