(198 days)
Ensmile Dental Plastic Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Ensmile is a sequence of transparent aligners created from a digital orthodontic treatment plan. The Ensmile aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The Ensmile Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.
The provided document is a 510(k) summary for the Ensmile Dental Plastic Aligners. It describes the device, its intended use, and its substantial equivalence to a predicate device (Invisalign System, K081960).
However, the document does not contain specific information regarding acceptance criteria for a performance study with numerical results, nor does it detail a study that proves the device meets such criteria in the way requested in the prompt.
The "Performance Data" section states that "Ensmile passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device." and lists:
- Biocompatibility testing per ISO 10993-1.
- Process Flow validation was performed to ensure that the finished device matches the software output specifications. "The output and work model and aligner were tested and compared. Aligners met the specifications of this testing."
It also mentions that "There are no differences between Ensmile and Invisalign System was defined therefore a performance testing was performed to Ensmile to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns."
Based on the provided text, I cannot fulfill the request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria with the level of detail requested, as that information is not present in the document. The document primarily focuses on establishing substantial equivalence through comparison of technological characteristics, materials, and mode of action, and high-level statements about passing tests.
Therefore, for each point requested:
- A table of acceptance criteria and the reported device performance: This information is not provided in a table format with specific metrics. The document only generically states that the aligners "met the specifications of this testing" for process flow validation and "passed" biocompatibility.
- Sample sizes used for the test set and the data provenance: No sample sizes are provided for any performance testing, nor is the data provenance (e.g., country of origin, retrospective/prospective) mentioned for the "Process Flow validation" which is the closest thing to performance testing mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a clinical or performance study involving human experts for ground truth establishment.
- Adjudication method for the test set: Not applicable, as no such test set or adjudication process is described.
- 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. This device is a physical aligner, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "software output specifications" and "Process Flow validation," implying the software's role in creating the aligner design. However, no specific "standalone" performance metrics of the algorithm itself are provided. The "performance testing" mentioned seems to be related to the physical product meeting design specifications rather than the software's interpretive abilities.
- The type of ground truth used: For the "Process Flow validation," the ground truth seems to be the "software output specifications" and the "work model." It's about manufacturing accuracy against a digital plan, not a clinical ground truth like pathology or outcomes data.
- The sample size for the training set: Not applicable, as there's no mention of an AI model being trained, or a training set being used in the context of device performance. The software mentioned is for design, not for data-driven diagnostic or predictive tasks in the way "training set" usually implies for AI devices.
- How the ground truth for the training set was established: Not applicable for the same reason as point 8.
§ 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.