Search Results

Nuvola® aligner is intended for the orthodontic treatment of malocclusion.

The Nuvola® device is a doctor-prescribed series of removable plastic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient's teeth in rements from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient's dentition in its current state and then each subsequent aligner stage of the dentition shifted gradually toward the final desired position.

The provided document for the K222418 submission of the Nuvola aligner does not contain the detailed information necessary to fully address all aspects of acceptance criteria and the study proving device performance as requested. Specifically, it lacks a dedicated section outlining acceptance criteria with corresponding performance metrics from a study dataset.

However, based on the non-clinical studies summarized, we can infer some aspects related to device validation. The document emphasizes that "Non-clinical tests have been conducted to verify that the Nuvola® aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate and reference devices."

Here's an attempt to construct the information based on the provided text, highlighting where data is not available or explicitly stated.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Nuvola® Aligner

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Invisalign System K220287) and a reference device (Ortho Aligner System K212496) primarily through non-clinical testing and comparison of technological characteristics. A formal study explicitly outlining acceptance criteria and a detailed performance study against a predefined test set with quantified metrics is not presented in the provided text in the typical format for AI/algorithm performance.

The "acceptance criteria" here appear to be framed around meeting pre-established specifications for manufacturing accuracy, biocompatibility, shelf life, packaging, and treatment planning software validation to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Manufacturing Validation: "The test has been repeated for 5 times with 5 different patient 3rd party software was used to perform point-to-point and critical displacement."
  • Data Provenance: The document does not explicitly state the country of origin for these 5 patient cases or whether they were retrospective or prospective. Given the company is based in Italy, the data could be European. The description suggests these were real patient cases used for validation.

3. Number of Experts Used and Qualifications:

• Manufacturing Validation (Aligner Fitting): The "prescribing doctor" checked the suitability, function, and form of the aligners. The number of doctors is not specified beyond "the prescribing doctor" checking the 5 treatment plans.
  • Qualifications: "Prescribing doctor" implies a dental practitioner, likely an orthodontist, but no specific years of experience or board certifications are stated.
• Other validations (Biocompatibility, Shelf life, Packaging, Software): These appear to be laboratory or engineering tests run against industry standards and regulations, rather than requiring expert adjudication of clinical outcomes.

4. Adjudication Method for the Test Set:

• Manufacturing Validation: For aligner fitting, the "prescribing doctor" checked. This implies a single expert review for each of the 5 cases. There is no mention of consensus or multiple adjudicators (like 2+1, 3+1). For manufacturing accuracy via software, it was likely an automated comparison to a tolerance.

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

• No MRMC comparative effectiveness study was done.
• The clinical performance testing for the device was not conducted, as stated: "Clinical Studies was not conducted for this 510(k) Notification. Clinical Performance testing was not needed to establish substantial equivalence to the predicate and reference devices." This suggests no human-in-the-loop performance evaluation was performed or necessary for this submission.

6. Standalone (Algorithm Only) Performance:

• The Nuvola®Web software is a "Treatment Planning platform," and the 3Shape Ortho System software is used for "tooth alignment" and "to produce standard 3D printer files."
• While the software components (Nuvola®Web and 3Shape Ortho System) were validated for compliance with specific standards (IEC 62304:2006+AMD1:2015 and 21 CFR part 11 for Nuvola®Web; implicit for 3Shape Ortho System which is an already cleared device K152086), there is no standalone performance study of the algorithm's output (e.g., predicted tooth movement accuracy) independent of the physical aligner or human intervention. The validation focused on the software's ability to manage treatment plans and produce correct 3D printer files, and the physical aligners' fit.

7. Type of Ground Truth Used:

• Manufacturing Validation (Digital to 3D Print): The ground truth appears to be the intended digital model (CAD/CAM model) from the treatment planning software, against which the 3D printed molds were measured.
• Manufacturing Validation (Aligner Fitting): The ground truth was based on the "pre-established specifications and acceptance criteria" for fit and function, assessed by the "prescribing doctor." This implies a clinical assessment or expert consensus on the desired fit.
• Biocompatibility, Shelf Life, Packaging: Ground truth for these was established by industry standards and regulatory guidelines (e.g., ISO 10993-1, ISTA 2A) and manufacturer's pre-defined specifications.
• Software Validation: Ground truth was compliance with specified software development and quality standards (IEC 62304, 21 CFR Part 11).

8. Sample Size for the Training Set:

• The document describes the device as a physical aligner and associated software for treatment planning. It does not indicate the use of machine learning or AI models developed by G.E.O. requiring a "training set" in the deep learning sense.
• The software components (Nuvola®Web and 3Shape Ortho System) are either COTS (Commercial Off-The-Shelf) software (3Shape Ortho System is K152086) or custom-developed traditional software validated per IEC 62304. Therefore, discussions of "training sets" are not applicable in this context.

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

• Not applicable, as no AI/ML training set is mentioned or implied. The software validation is based on traditional software engineering principles and regulatory compliance.

Ask a specific question about this device