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The DigiLine Direct Print Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The DigiLine Direct Print Aligner System repositions teeth by way of continuous gentle force.

The Proposed Device, DigiLine Direct Print Aligner System consists of multiple stages of 3D printed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental movements that move teeth by way of gentle continuous force to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. Once the treatment plan is reviewed and approved by a dental health professional, each aligner stage is fabricated by additive manufacturing, specifically 3D printing. The 3D printed aligner then undergoes post-processing and cleaning prior to packaging for patient use. DigiLine Direct Print Aligner System are direct-printed using DigiLine Direct Print Resin. DigiLine Direct Print Resin is a light-cured, methacrylate-based resin. Methacrylate-based resins are commonly used for the production of dental structures.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Device Name: DigiLine Direct Print Aligner System
Regulation Name: Orthodontic Plastic Bracket
Product Code: NXC
Predicate Device: Tera Harz Clear (K223355)
Reference Device: LuxCreo Clear Aligner (K212680)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for device performance (e.g., a specific percentage of dimensional accuracy or a force measurement). Instead, it describes general compliance with standards and internal specifications. The performance is assessed by demonstration of manufacturing validation and material testing meeting requirements.

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

• The document does not specify the sample size for any test sets.
• Data Provenance: The document does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. Given that no clinical studies were performed, this information is not applicable to patient data. The non-clinical tests would have been performed in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission relies on non-clinical performance testing (manufacturing validation, material testing, biocompatibility) against established standards rather than clinical data requiring expert review for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical studies requiring expert review for ground truth were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical Testing was not required for the Predicate Device or the DigiLine Direct Print Aligner System."
• Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. The device is a physical orthodontic aligner system, not an AI software.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The DigiLine Direct Print Aligner System is a physical orthodontic device manufactured using 3D printing. It is not an algorithm or AI software for which standalone performance would be measured. While a "digital scan" is used for design, the core device under review is the physical aligner.

7. Type of Ground Truth Used

• The "ground truth" for proving the device meets acceptance criteria is based on engineering standards, internal design specifications, and quality control metrics established for manufacturing, materials, and biocompatibility.
• Specifically:
  • Compliance with ISO 20795-2:2013 for material performance.
  • Compliance with ISO 10993-1 for biocompatibility.
  • Demonstration of successful fabrication and meeting pre-established dimensional accuracy and quality criteria during manufacturing validation.

8. Sample Size for the Training Set

• Not applicable. This section relates to the training of an AI algorithm. The DigiLine Direct Print Aligner System is a physical medical device. The "design" phase involves digital scans and physician approval, but this is distinct from a machine learning training set.

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

• Not applicable, as there is no AI algorithm training set for this physical device.

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