(131 days)
The Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner positions teeth by way of continuous gentle force.
The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.
A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition. 3Shape A/S Ortho System is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
The provided document is a 510(k) Premarket Notification from the FDA for the Redline Aligner. It primarily demonstrates substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific acceptance criteria in the manner one might expect for an AI/ML medical device.
Therefore, it is not possible to fully answer all aspects of your request as the document does not contain information about a study that "proves the device meets the acceptance criteria" in the context of an AI/ML device. The document focuses on showing the Redline Aligner's equivalence to existing devices based on design, materials, and manufacturing processes, rather than on its performance in a clinical trial or a specific AI-driven task.
However, I can extract the information that is present and indicate what is missing:
Description of Acceptance Criteria and Device Performance (Based on provided document)
The document describes non-clinical testing for the Redline Aligner, focusing on manufacturing accuracy and material properties, rather than clinical performance data against specific outcomes.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manufacturing Dimensional Accuracy: | Translational measurement: Within 0.150mm (150 microns) of the target input value. There were no statistical differences in measured values among groups, indicating results were within the predefined tolerance. |
| Final Aligner Fitness: | All aligners included in the study passed and were deemed an excellent fit. |
| Biocompatibility: | Redline Aligners were concluded to be biocompatible for their intended use. Material testing was performed according to ISO 10993-1. Additional cytotoxicity testing was performed on final manufactured aligners according to ISO 10993-5:2009. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions an "internal manufacturing validation" where "The final aligner fitness was evaluated according to the in-house fitness acceptance criteria," and "all the aligners including in the study passed." A specific number of aligners tested is not provided.
- Data Provenance: The testing was "internal manufacturing validation," implying it was conducted by Johns Dental Laboratories. The country of origin of this internal data is not specified, but the applicant (Johns Dental Laboratories) is based in Terre Haute, Indiana, United States. It is a retrospective evaluation of manufacturing output.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "in-house fitness acceptance criteria" would likely be based on internal quality control standards established by qualified personnel, but the roles and qualifications are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. The document only states that "all the aligners including in the study passed and were deemed an excellent fit," suggesting a straightforward pass/fail assessment against defined criteria rather than a multi-reader adjudication process typically associated with AI/ML ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with/without AI Assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The Redline Aligner is a physical medical device (orthodontic plastic bracket) and not an AI/ML algorithm that assists human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, a standalone performance study for an algorithm was not done. The "3Shape A/S Ortho System" software is mentioned as being used "to develop treatment plan" and "to generate standard format 3D files," but this software's performance as a standalone AI/ML device is not evaluated here. The 510(k) is for the physical aligner.
7. The Type of Ground Truth Used:
- Ground Truth: For dimensional accuracy, the "target input value" from the digital treatment plan served as the reference. For aligner fitness, "in-house fitness acceptance criteria" were used as the standard. For biocompatibility, international standards (ISO 10993-1, ISO 10993-5:2009) were the ground truth for material safety.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. The Redline Aligner is a manufactured physical device, not an AI/ML algorithm that requires a training set. The 3Shape A/S Ortho System is external software, and its training set information is not provided nor relevant to the Redline Aligner's 510(k).
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for the physical device.
§ 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.