(30 days)
The 3MM Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
The 3M Clear Tray Aligner System is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the 3M Clear Tray Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic travs intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
The provided text describes the 3M™ Clear Tray Aligner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report or performance study for a diagnostic or AI-driven device.
The document is a 510(k) summary for a medical device, focusing on demonstrating substantial equivalence to already marketed predicate devices (Invisalign® System and ClearCorrect System) rather than presenting a performance study with detailed acceptance criteria for a novel AI or diagnostic algorithm.
Here's a breakdown of why this information is not present in the provided text, and what is available:
1. A table of acceptance criteria and the reported device performance:
- Not Available: The document does not provide a table of acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for device performance in the context of an AI or diagnostic tool.
- What is available: The document focuses on demonstrating that the 3M™ Clear Tray Aligner is "as safe, as effective, and is substantially equivalent" to predicate devices based on:
- Shared indications for use.
- Similar technological characteristics (thermoplastic material, incremental tooth movement principle).
- Similar mechanism of action.
- Bench testing for material properties (translucency, shelf life, life expectancy) which showed "acceptable" properties.
- Biocompatibility testing (cytotoxicity, sensitization, irritation) which "met the requirements of the study protocols" and found the material "non-cytotoxic, non-sensitizing and is not an intracutaneous irritant."
- Software verification and validation for the ordering and processing software, which was considered "moderate" level of concern.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Available: There is no mention of a "test set" in the context of evaluating an AI or diagnostic algorithm's performance. The document describes testing of the physical material and software, not an algorithm's diagnostic accuracy on a dataset.
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 Available: Not applicable, as there's no mention of a test set requiring expert-established ground truth for an AI or diagnostic assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Available: Not applicable for the same reason as above.
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 Available: The device is a physical orthodontic aligner system, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Available: The device is a physical product. While it uses software for ordering and design, the submission does not perform a standalone performance evaluation of a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available: Ground truth, in the context of AI/diagnostic evaluation, is not mentioned. The "ground truth" for the material and software testing would be established by the specifications of those tests (e.g., chemical composition standards for biocompatibility, functional requirements for software).
8. The sample size for the training set:
- Not Available: Not applicable, as there is no AI model or algorithm being "trained" in the sense of machine learning for diagnostic purposes. The software mentioned facilitates ordering and processing, but it's not described as an AI algorithm that learns from a training set.
9. How the ground truth for the training set was established:
- Not Available: Not applicable for the same reason as above.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (orthodontic aligners). Its purpose is to demonstrate substantial equivalence to existing devices through comparisons of indications for use, technology, materials, and limited bench and biocompatibility testing. It does not describe an AI or diagnostic algorithm, nor does it present a study with performance-based acceptance criteria typical for such technologies.
§ 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.