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The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Orthocaps TwinAligner® System consists of a series of custom made removable clear plastic orthodontic aligners that sequentially positions teeth by way of continuous gentle force.

An electronic scan or mold impression of the patient's teeth in an untreated state is provided by a dental or orthodontic professional. From the digital scan, Orthocaps technicians design a series of intermediate models corresponding to each stage of treatment 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, Orthocaps produces the aligner trays formed from clear, thin thermoformed plastic. The trays are sent back to the physician for patient fit and treatment. Additional trays are provided sequentially to gradually move the target teeth to the designed position, which is monitored throughout treatment by the physician. The aligner trays are held in place by pressure and can be removed by the patient at any time. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printed files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation for this subject device is the 3Shape reference predicate.

The Orthocaps TwinAligner® System is a medical device for orthodontic treatment. The information provided does not detail specific acceptance criteria for performance metrics (such as accuracy of tooth movement or treatment efficacy). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and safety (biocompatibility).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific quantitative performance acceptance criteria are not explicitly stated for the device's functional efficacy (e.g., degree of tooth movement precision), the acceptance criteria primarily revolve around demonstrating substantial equivalence to predicate devices and acceptable biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance:

• Biocompatibility Testing: The document does not specify a "sample size" in terms of number of devices tested for biocompatibility. The tests were performed "in accordance to ISO 10993-1 and its applicable parts," but the number of samples or batches is not mentioned.
• Verification and Validation Testing: The document mentions using "a physical model cast impression" but does not specify the sample size (i.e., how many casts or digital models were compared).
• Data Provenance: Not explicitly stated for biocompatibility or V&V testing, but it can be inferred that these were laboratory-based tests conducted by/for Ortho Caps GmbH. No country of origin for patients or specific retrospective/prospective study design is relevant here as no clinical data was submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Biocompatibility Testing: The ground truth is established by the specified ISO standards (e.g., ISO 10993-5, 10993-10). No human experts were used to "establish ground truth" beyond the standard laboratory procedures and interpretation of results according to ISO guidelines.
• Verification and Validation Testing: This involved comparing physical and digital models. The "ground truth" here is the design specification or the intended digital model. The comparison would likely be performed by engineers or technicians, but no specific "experts" for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set:

• Biocompatibility Testing: No human adjudication method (like 2+1 or 3+1) is described. The results are based on standardized laboratory assays and their interpretation against pass/fail criteria defined by the ISO standards.
• Verification and Validation Testing: No adjudication method is mentioned. The comparison of physical and digital models would likely involve quantitative measurements and adherence to pre-established specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not included in this submission." The submission relies on substantial equivalence to predicate devices which have established clinical safety and effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device is a physical product (aligners) manufactured using software for treatment planning. The "software application used for the manufacturing validation for this subject device is the 3Shape reference predicate."
Verification and validation testing confirmed "no measurable deviation between physical and digital models." This can be considered a standalone performance assessment of the manufacturing process driven by the software, ensuring the physical output matches the digital plan. However, this is not a standalone clinical performance study of the algorithm's ability to predict tooth movement in patients.

7. The Type of Ground Truth Used:

• Biocompatibility: The ground truth is defined by the objective pass/fail criteria specified in the international ISO 10993 standards for biological evaluation of medical devices.
• Verification and Validation: The ground truth is the "preestablished specifications" and the intended digital model for the aligners.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (aligners) and the manufacturing process uses "standard dental software" (like 3Shape Ortho System) which is a reference predicate. There is no mention of a proprietary AI algorithm developed by Ortho Caps GmbH that underwent a training phase.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no described training set for a proprietary algorithm. The software used is described as "standard dental software" or a "reference predicate." The ground truth for such software would typically be derived from extensive orthodontic principles, biomechanical models, and clinical experience embedded in their design and development, rather than a specific "training set" in the context of machine learning.

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