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Fas Aligner System is intended for the orthodontic treatment of malocclusion.

Fas Aligner System consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. This removable plastic orthodontic aligners intended as an alternative to conventional wire and bracket technology. Fas Aligner System are designed based on traditional mold impression or digital scans of the patient's dentition submitted by a dental health professional (e.g., a dentist or orthodontist).

Fas Aligner System 's staff in the Prescription and Planning area create the virtual planning including the attachments, as well as the movements they consider necessary to achieve the intended tooth correction. For this process the following previously released software Nemocast (K232549).

The 3D specialists use the planned data to produce the complete product design. The responsible of the Planning/Prescription department reviews the design to verify that it has been done as required and, if necessary, proposes changes.

Once the design has been approved by the clinician, the next phase of printing and preparation of models is carried out. This phase takes place in the Printer Room and is carried out by 3D Printing Technicians. For the entire manufacturing process, the models are identified with the clinical case number.

The thermoforming equipment is used for the manufacturing process of the aligners. The printed model is placed on the platform and the thermoforming sheet is placed, which is made with material previously released by means of the K200125 (Erkodur).

Once the printed thermoforming sheet is obtained, the contour of the thermoforming sheet is cut out, eliminating the edges. The gingival margins are trimmed.

The product is not sent sterile, it is cleaned to remove all residues that may have remained from the manufacturing process.

The product, the splint, is placed in labeled bags. The aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Fas Aligner System." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the Fas Aligner System itself. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for the Fas Aligner System is not explicitly provided in this document.

However, based on the non-clinical testing summary, we can infer some information about general performance and safety criteria, primarily through comparison to the predicate device and relevant standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" for the Fas Aligner System are primarily that its technological characteristics and performance are comparable to the predicate device, Nuvola® Aligner (K222418), and that it meets relevant safety standards.

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

• Test Set Sample Size: Not applicable/Not provided for the Fas Aligner System in this document. The document describes non-clinical testing (durability, manufacturing validation, biocompatibility) but does not refer to a "test set" of patient data for performance evaluation in the way a clinical study would.
• Data Provenance: The durability and manufacturing validation tests were "internal." The biocompatibility testing followed ISO standards. The material characterization references K200125, which would contain its own original data provenance.

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

• This information is not provided as no clinical or comparative performance study using human readers/experts to establish ground truth is described. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material properties, manufacturing robustness, and biocompatibility, as verified by technical personnel during the internal tests.

4. Adjudication Method for the Test Set

• Not applicable/Not provided as there is no described test set requiring human adjudication.

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

• No, a MRMC comparative effectiveness study was not conducted or presented in this submission. The document explicitly states: "No clinical testing was performed in support of this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study of the Fas Aligner System (as a whole device) or its underlying planning algorithm was not conducted or presented. The submission focuses on the substantial equivalence of the physical aligners and manufacturing process, and acknowledges the use of FDA-cleared Nemocast software for planning, but does not present a standalone performance evaluation of that software in the context of this submission.

7. Type of Ground Truth Used

• For the non-clinical tests described:
  • Durability and Manufacturing Validation: The "ground truth" would be established engineering specifications and internal quality standards for mechanical integrity and process robustness as validated through internal testing.
  • Material Characterization: Scientific and engineering standards for material properties.
  • Biocompatibility: International standard ISO 10993-1 and ISO 10993-5, representing accepted biological safety benchmarks.

8. Sample Size for the Training Set

• Not applicable/Not provided. This submission does not describe a machine learning algorithm developed by Xplora 3D Europe S.L. for which a training set would be relevant. The planning software mentioned (Nemocast) is a previously cleared device (K232549), and any training data for that software would have been part of its original submission.

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

• Not applicable/Not provided. See point 8.

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