(84 days)
Ohlendorf Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The Ohlendorf Clear Alginer positions teeth by way of continuous gentle force.
The Ohlendorf Clear Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane.
A dental clinician prescribes the Ohlendorf Clear Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to the using standard dental software for planning the tooth alignments.
The software used is Ortho Analyzer by 3Shape (Reference device K180941). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models.
After the plan is developed by Ohlendorf, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, Ohlendorf produces the aligner trays. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.
The clear, thin, thermoplastic polyurethane-polyester composite resin material used for fabrication of the Ohlendorf Clear Aligner is commonly used in many dental and orthodontic appliances, including the predicate clear aligners.
The provided document is a 510(k) summary for the Ohlendorf Clear Aligner. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive study proving the device meets specific performance acceptance criteria for an AI/algorithm-driven medical device.
The "Device Testing" section mentions "Laboratory Testing" and states:
"Test data were submitted to:
- assure the mechanical properties of the aligner material ■ meet specifications for up to 5 years shelf life [according to ASTM D638 standard’s testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)];
- assure the aligner material packaging retains the required moisture barrier properties;
- validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner’s digital design and the manufactured aligners."
It then concludes with: "All testing met the pre-determined acceptance criteria."
However, the document does not provide the specific acceptance criteria values or the reported performance data for these physical and manufacturing properties. It also explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device."
Therefore, based on the provided text, it's not possible to fully answer your request regarding the acceptance criteria and study details as they would apply to an AI/algorithm-driven device with typically robust clinical or performance studies. The device in question is a physical medical device (clear aligners) and its clearance is based on substantial equivalence to a predicate device, primarily focusing on material and manufacturing process similarity, not on an AI algorithm's diagnostic or predictive performance.
The questions you've posed (e.g., MRMC studies, ground truth for AI, training set size) are highly relevant for AI/ML-based medical devices that perform tasks like image analysis or diagnosis. This document, however, does not describe such a device or its associated studies.
Given the information, I can only provide a hypothetical table based on the mention of "pre-determined acceptance criteria" for the physical and manufacturing aspects, and state that the detailed study information for AI-specific performance is not available in this document.
Based on the provided document, here's what can be extracted and what cannot:
The document describes the Ohlendorf Clear Aligner, a physical medical device for orthodontic treatment, and its 510(k) clearance process. The clearance is based on substantial equivalence to an existing predicate device. The performance claims primarily relate to the material properties and manufacturing consistency of the physical aligners, not the performance of an AI algorithm in a diagnostic or treatment planning context that would typically involve human-in-the-loop performance or standalone AI performance evaluation.
1. A table of acceptance criteria and the reported device performance
Based on the document, specific numerical acceptance criteria and reported performance values for the mechanical properties (tensile strength, elongation, etc.) or manufacturing validation are not provided. The document states: "All testing met the pre-determined acceptance criteria."
| Acceptance Criteria Category | Acceptance Criteria (Specific values not provided in document) | Reported Device Performance (Specific values not provided in document) |
|---|---|---|
| Material Properties | ASTM D638 standards for: | All tests met pre-determined acceptance criteria. |
| Tensile Strength (PSI) | To meet specifications for up to 5 years shelf life. | |
| Elongation (%) | ||
| Tensile @ Yield (PSI) | ||
| Elongation @ Yield (PSI) | ||
| Tensile Modulus (PSI) | ||
| Packaging Properties | Retain required moisture barrier properties. | All tests met pre-determined acceptance criteria. |
| Manufacturing Consistency | Validate processes to ensure consistency between digital design and manufactured aligners. | All tests met pre-determined acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993 (Parts 5, 10) | All testing showed material met requirements and is safe/biocompatible. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the material property or manufacturing consistency tests. It also does not mention the provenance of any data in terms of country of origin or clinical (retrospective/prospective) studies, as such studies were explicitly stated as "not required" for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a physical product (clear aligner), and the studies described are related to its material and manufacturing properties, not an AI algorithm requiring expert ground truth for clinical performance. The "ground truth" here would relate to laboratory standards (e.g., ASTM D638).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the type of testing described (material and manufacturing process validation).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC study was not done. The document explicitly states: "Neither animal nor human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This type of study is relevant for AI-assisted diagnostic devices, which the Ohlendorf Clear Aligner is not described as.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device description mentions the use of "Ortho Analyzer by 3Shape (Reference device K180941)" software for planning, but the submission is for the physical aligner product, not the software itself as a novel AI/ML device. The software is used by a dental clinician, who then approves the plan before manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the material and manufacturing tests, the "ground truth" would be established by engineering standards (e.g., ASTM D638 for material properties) and internal quality control specifications for manufacturing consistency. It does not involve clinical ground truth types like pathology or outcomes data for performance evaluation.
8. The sample size for the training set
This question is not applicable. The device itself is a physical product. While software (Ortho Analyzer) is used for planning, the document does not describe the development or training of a novel AI algorithm by the applicant, nor does it specify a training set for such a purpose. The 3Shape software is referenced as a separate device (K180941).
9. How the ground truth for the training set was established
This question is not applicable as no training set for a novel AI algorithm developed by the applicant is described in this document.
§ 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.