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The MyClearALIGN Dental Aligner System is indicated for the alignment of all permanent teeth/full permanent dentition during orthodontic treatment of malocclusions by way of continuous gentle forces.

MyClearALIGN Dental Aligner System device is a clear aligner system fabricated using the commercially available Zendura FLX, a clear, thin thermoformed Copolyester – Polyurethane Composite with 2 outer layers of cycloaliphatic polyester and an inner layer of polyether polyurethane. The pressure areas create forces that combine to form couples and thus a moment around or near the center of resistance or center of rotation of the tooth. A series of aligners is fabricated to sequentially move the teeth from their original positions of better alignment. Each set of aligners is designed to be replaced after approximately 2 weeks of 20-22 hours of wear per day (Approximately 300 hours per aligner). Each tooth is moved no greater than 0.25mm in one aligner stage (approximately 2 weeks of 20-22 hours of wear per day).

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative performance acceptance criteria through the kind of study structure typically seen for novel diagnostic AI/ML devices. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, expert adjudication, MRMC studies, ground truth for training) are not applicable to this type of medical device (physical dental aligners).

This document demonstrates the MyClearALIGN Dental Aligner System's equivalence to a predicate device primarily through bench testing and biocompatibility studies, not performance studies based on human interpretation or AI algorithm output. There is no mention of an AI/ML component to this device.

Acceptance Criteria and Study for MyClearALIGN Dental Aligner System

Based on the provided FDA 510(k) summary for the MyClearALIGN Dental Aligner System (K221475), the device is cleared based on its substantial equivalence to a predicate device (ULab Systems Dental Aligner Kit, K192596), not on meeting specific quantitative performance acceptance criteria like those used for AI/ML diagnostic tools.

The "acceptance criteria" here are implicitly satisfied by demonstrating that the device is "as safe, as effective, and performs as well as the predicate device" through non-clinical (biocompatibility and bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (physical dental aligner) and the 510(k) pathway, direct quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance is based on demonstrating equivalence in materials, function, and safety to a legally marketed predicate.

• Trouser Tear strength
• Light Transmission and Haze
• Thermoforming verification
• Compatibility with Commercial Denture Disinfectant
• Exposure to Common Beverages
• Extended Saline Exposure (37°C and 47°C)
• Outdoor Exposure Effects
• Stain resistance
• Flexural Properties
• Tensile & Elongation
• Stress Relaxation
  Conclusion: Results of all testing demonstrate the device is comparable to other currently marketed devices and is substantially equivalent. |
  | Indications for Use Equivalence: Device performs the same function for the same patient population as the predicate. | The MyClearALIGN Dental Aligner System is indicated for "alignment of all permanent teeth/full permanent dentition during orthodontic treatment of malocclusions by way of continuous gentle forces," which is stated to be the same as the predicate device. |
  | Technological Equivalence: Device operates on the same scientific principles and has similar design features as the predicate. | Both are clear plastic sequential aligners, have the same intended/indications for use, same principle of operation, fabricated from digital scans, and made of thermoplastic (Zendura-FLX). Conclusion: Substantially equivalent in terms of technological characteristics, features, specifications, materials, and mode of operation. |
  | Safety and Effectiveness: Overall, the device is as safe and effective as the predicate. | Conclusion: "MyClearALIGN Dental Aligner System is as safe, as effective, and performs as well as the predicate device." |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission for a physical device. The "test set" here refers to samples of the material and finished product used in bench testing (e.g., samples for tensile strength, biocompatibility). The document does not specify the exact number of samples for each bench test, but implies that sufficient samples were tested to gain confidence in the material properties and device performance.
• Data Provenance: Not directly applicable as this isn't clinical performance data from patients. The testing was conducted "in accordance with and in conformance to applicable device regulations and guidance," implying standard laboratory testing practices.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for material properties and biocompatibility as defined by the referenced ISO standards and design verification reports.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication in the context of the bench and biocompatibility tests conducted for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI tools that assist human readers. This product is a physical dental aligner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• For Biocompatibility: Ground truth is established by adherence to recognized international standards (ISO 10993 series) and their defined toxicological endpoints.
• For Performance Bench Testing: Ground truth is established by engineering specifications, material science principles, and adherence to internal design verification reports and standard testing methodologies (e.g., for tensile strength, flexural properties, chemical resistance).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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