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The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

The Concinnity Aligners™ is a custom clear aligner system. They are a series of doctor (orthodontist or dentist) prescribed clear plastic removable aligners that are used as alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.

The Concinnity Aligners™ comes in two forms: a polyurethane-based material used to treat malocclusion in heavy bruxers, and a second form made from cycloaliphatic co-polyester polyurethane used in for all other patients. The polyurethane material is identical to the predicate device's material, and the cvcloaliphatic co-polyester and polyurethane materials are used in the reference device.

The manufacturing of Concinnity™ Aligners begins with the clinician prescribing aligners to treat a patient's malocclusion. The decision to use clear aligner-based treatment is made by the clinician. In addition to the prescription the clinician also provides Drake Precision Dental Laboratory (DPDL) with a model of the patient's dentition. The clinician can generate a digital file by scanning the patient's mouth directly using Intraoral scanner (IOS) software, such as 3Shape Trios or iTero software. A mold of the patient's dentition is obtained using traditional impression material or by converting the mold to a stone model.

Impressions are taken by the dental clinician and submitted to Drake Labs along with the physician's prescription. All incoming impressions are logged and tracked under the DPDL QMS system. If DPDL receives a digital file it is tracked through its QMS system without any modifications. If DPDL receives a stone model from the information is entered and tracked as per QMS. The stone model is scanned using a digital scanner and converted into a digital file. Upon receipt of traditional impression molds, they are converted to stone models which can be scanned and digitized.

The digital files are sent to a third party design firm which develops the treatment plan. The third-party design firm utilizes the digital files and the prescription from the clinician to create a customized treatment plan that is reviewed and approved by the clinician. The customized plan generates a series of *.stl CAD files for building models that allow fabrication of aligners that gently move the teeth in small increments. The third party uses the 3Shape Clear Aligner Studio (K180941) to develop the treatment plan. The treatment plan is sent to the prescribing clinician for approval before it is sent back to DPDL.

Once DPDL receives these *.stl CAD files of the treatment plan the CAD unit in DPDL receives the documents, updates the QMS documentation and manufacturing begins. The DPDL manufacturing unit generates sequential 3D printed models replicating the clinician approved treatment plan. The sequential models are 3D printed and are used to generate clear thermoplastic aligners.

The aligners are cut to fit dentition, the cleaned and polished to remove rough edges. The sequential aligners are the packaged and labeled. Quality assurance ensures that the correct aligners are being shipped to the prescribing physician. The final product is released and shipped to the prescribing clinician who is responsible for ensuring the patient's safe use of the device.

The Concinnity™ Aligners are manufactured using thermoplastic polymers used by the predicate and reference devices. Manufacturing, processing, labeling, and shipping of the aligners are performed under strict quality control procedures that ensures Concinnity Aligners™ is manufactured under the QMS.

Drake Labs sends the aligners to the doctor who delivers them to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.

The provided text describes the Concinnity Aligners™ and a study conducted to demonstrate their performance. However, much of the requested information regarding acceptance criteria and performance study details (e.g., specific metrics for acceptance, sample sizes for test and training sets, expert qualifications, and detailed statistical results) is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and manufacturing fit validation, rather than a clinical trial with human-in-the-loop or standalone AI performance.

Therefore, many sections of your request will be answered with "Not explicitly stated in the document" or derived from the available information.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

2. Sample size used for the test set and data provenance

• Sample Size for Test Set: For the "manufacturing fit validation study," four complete orthodontic cases were evaluated.
• Data Provenance: The document does not explicitly state the country of origin for these four cases. It implies they are real orthodontic cases from clinicians providing prescriptions and dental impressions to Drake Precision Dental Laboratory. The study was conducted by Drake Precision Dental Laboratory (DPDL). The study is retrospective in the sense that existing case data (impressions/digital scans) for the chosen cases would have been used for the manufacturing validation.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

• Number of Experts: "A licensed clinician then evaluated the clear aligner's quality for fit, function, and adaptability." This suggests at least one licensed clinician.
• Qualifications of Experts: Assumed to be a "licensed clinician." Specific qualifications (e.g., orthodontist, years of experience) are not explicitly stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: None explicitly described. The evaluation was performed by "a licensed clinician." There is no mention of multiple reviewers or an adjudication process for the manufacturing fit validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for AI-assisted diagnostic devices. The Concinnity Aligners™ are a physical medical device (orthodontic aligners), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: The core device (Concinnity Aligners™) is not an algorithm, but a manufactured product. The software used for treatment planning (3Shape Clear Aligner Studio, K180941) is a third-party design firm's tool. The submission is for the aligners themselves, not independent software performance. Therefore, a "standalone algorithm performance" study is not applicable in the context of this device. The closest equivalent would be the assessment of the digital model files' accuracy, which was part of the manufacturing fit validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the "manufacturing fit validation," the ground truth or reference points were:
  • The digital model files (presumably approved by the clinician, representing the intended treatment plan).
  • The "pre-determined evaluation criteria" used by the licensed clinician for assesssing fit, function, and adaptability. These criteria are not detailed in the document.
  • It is not based on pathology or clinical outcomes data, but on the physical accuracy of the manufactured aligners against the digital design and their subjective fit assessment by a clinician.

8. The sample size for the training set

• Sample Size for Training Set: The document describes the device, its manufacturing process, and a manufacturing fit validation study. There is no mention of a "training set" as this is not a machine learning/AI device that requires a training phase.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" or AI component described in the submission that would require establishing ground truth for training.

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