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The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and custom-made by dental professionals using uLab Systems proprietary technology. The aligners are made of aesthetic and medical grade materials chosen by doctors for their patients. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

The provided document does not describe a study that proves the device meets specific acceptance criteria in the context of AI performance for a diagnostic or treatment planning system.

The document is a 510(k) summary for the ULab Systems Dental Aligner Kit, a physical medical device (clear aligners) used for orthodontic treatment. The "performance data" section focuses on biocompatibility, design verification, user validation, packaging verification, and physical properties testing for the physical aligner product itself, not the performance of an AI algorithm in a diagnostic or treatment planning capacity.

Therefore, I cannot extract the requested information regarding AI acceptance criteria and study details from this document. The document describes the aligners as "designed and custom-made by dental professionals using uLab Systems proprietary technology," and mentions "dental software, the uLab Systems uDesign, K171295, for tooth alignment." However, it does not provide details on the AI performance or any studies related to its AI components.

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3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion

The 3M Clarity Aligners are 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 3M Clarity Aligners 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 trays 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 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.

There are no changes being made to the 3M Clarity Aligners themselves. Both the proposed 3M Clarity Aligners and the primary predicate 3M Clarity Aligners (K183159) have the same indications for use. The present premarket submission is to account for the overall software cumulative changes including the integration of the ULab software (K171295).

The provided document is a 510(k) summary for the 3M Clarity Aligners. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a standalone study with performance metrics, human reader studies (MRMC), or a detailed breakdown of sample sizes, ground truth establishment, or expert qualifications for testing and training sets.

The relevant section for performance testing states:
"Results of verification and validation testing demonstrate the proposed 3M Clarity Aligners showed conformity with pre-established specifications and acceptance criteria. Software testing was conducted in accordance with "General Principles of Software Validation; Final Guidance for Industry and FDA Staff'' dated January 11, 2002 and Medical Device Software - Software Life Cycle Processes; ANSI/AAMI/IEC 62304:2015."

This statement confirms that testing was performed against acceptance criteria and established standards, but it does not provide the acceptance criteria themselves, nor the specific performance results or details of the study proving the device met them.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement.
6. If a standalone performance (algorithm only) was done (beyond the general statement of "conformity with pre-established specifications").
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on the claim of substantial equivalence based on the device's identical indications for use, technological characteristics (except for software improvements), and manufacturing processes compared to its predicate device. The software changes are noted to include the integration of ULab software, which allows the Dental Health Professional to directly own and submit the treatment planning process for manufacturing without interaction with 3M technicians.

In summary, while the document states performance testing was conducted, it does not disclose the detailed results or methodologies required to answer your specific questions.

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