Search Results

ClearForm Aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusions. The aligners position teeth by way of continuous gentle forces.

ClearForm Aligners consist of a series of customized removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force.

A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop an orthodontic treatment plan. Using the software dental technicians produce a series of intermediate digital models corresponding to each stage of treatment, gradually aligning the patient's teeth according to the dental health professional's prescriptions.

The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

The prescribing doctor reviews and approves the treatment plan before the models/molds are produced.

Once approved, physical models are produced from the digital model files. The aligner trays are formed over the physical models by using thermal forming equipment and a thermoplastic sheet. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.

This document is a 510(k) Premarket Notification for ClearForm Aligners, an orthodontic device. It provides information for establishing substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance study.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (such as acceptance criteria table, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. The document describes a comparison to predicate devices, non-clinical performance data (manufacturing validation, material properties, biocompatibility), and states that no clinical performance data was provided.

Here's what can be extracted based on the provided text, while noting the limitations:

Device Name: ClearForm Aligners

Device Type: Orthodontic Plastic Bracket (Class II)

Purpose of this Document: 510(k) Premarket Notification to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of Device Acceptance/Evaluation from this Document:

The acceptance for this device is based on demonstrating substantial equivalence to predicate devices through similarities in indications for use, technology, and non-clinical performance testing.

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a 510(k) submission for an orthodontic aligner and not an AI/ML-driven device with specific performance metrics like sensitivity/specificity, a direct "acceptance criteria" table with reported performance in that sense is not present. However, the document outlines "acceptance criteria" for the manufacturing validation.

Note: These are manufacturing process validation criteria, not clinical performance criteria for diagnosis or treatment outcome effectiveness.

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

• Test Set Sample Size: Not applicable in the context of an AI/ML performance study. The "test set" here refers to samples used for manufacturing validation. The document states "Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners." The exact number of samples for each aspect is not specified, but it's related to a manufacturing process, not patient data for an algorithm's performance.
• Data Provenance: Not applicable in the context of patient data for an algorithm. The data provenance described is from their internal manufacturing validation process.

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

Not applicable. Ground truth for an AI/ML model for diagnostic/prognostic purposes is not established for this device's 510(k) submission. The "ground truth" here is the "target input value" (digital design) for manufacturing accuracy comparison.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process for diagnostic labels or classifications is described. The "adjudication" for manufacturing validation was likely based on comparison to design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Clinical performance data was not provided for ClearForm Aligners." Therefore, no MRMC study or effect size of human readers improving with AI assistance vs. without AI assistance was reported.

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

No. This device is not an AI/ML algorithm. The software mentioned (3Shape A/S Ortho System) is for treatment planning and model creation, and it has its own 510(k) clearance (K180941). The ClearForm Aligners itself is a physical medical device.

7. The Type of Ground Truth Used:

• For Manufacturing Validation: The ground truth used was the "target input value," which refers to the digital design specifications derived from the orthodontic treatment plan created using the specialized CAD/CAM software. The accuracy of the manufactured components (digital dentition models, 3D printed molds, thermoformed aligners) was measured against these digital design specifications.
• For Substantial Equivalence: The ground truth for this regulatory pathway is the characteristics and safety/effectiveness profile of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set of data.

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

Not applicable. (See #8)

In summary: This 510(k) document is for a physical medical device (orthodontic aligners). The regulatory pathway for this device is primarily based on demonstrating substantial equivalence to existing predicate devices and providing non-clinical performance data related to manufacturing accuracy and material properties. It does not involve a "study that proves the device meets acceptance criteria" in the context of AI/ML algorithm performance on patient data, nor does it present clinical trial data for effectiveness.

Ask a specific question about this device