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The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.

Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

The provided text describes a 510(k) premarket notification for "Clear Image Aligners" by Specialty Appliance Works, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or not provided in this regulatory submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance. Instead, it aims to demonstrate substantial equivalence to a legally marketed predicate device.

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

Not applicable. No "test set" in the context of performance evaluation (e.g., for AI algorithm metrics) is described. The submission states that clinical testing was not necessary due to the established performance of sequential aligners.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. No ground truth establishment by experts for a performance study is described.

4. Adjudication Method

Not applicable. No adjudication method for a test set is described.

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

Not applicable. No MRMC study is mentioned. This device is an aligner, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical orthodontic aligner, not an algorithm. The manufacturing process uses 3Shape orthodontic software, but the submission doesn't describe a standalone performance study of this software or the aligner.

7. Type of Ground Truth Used

Not applicable. No performance study with ground truth is described.

8. Sample Size for the Training Set

Not applicable. No training set for an AI algorithm is described.

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

Not applicable. No training set or ground truth establishment process is described.

Summary of the Study and Substantial Equivalence Claim:

The submission asserts that clinical testing was not necessary because:

• Established Performance: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998."
• Substantial Equivalence: The Clear Image Aligners are deemed substantially equivalent to the predicate device (Derby Dental Laboratory Custom Clear Aligner System, K173785) in terms of:
  • Indications for Use
  • Design and Technology
  • Device Classification Name (Orthodontic Plastic Bracket)
  • Product Code (NXC)
  • Classification (Class II)
  • Mode of Action (alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays)
  • Method of Use
  • Prescription Status (Prescription)
  • Software Used during manufacturing (3Shape Ortho System)
  • Sterility (Provided Non-Sterile)
  • Material (Essix Ace plastic - K062828, described as a thin thermoformed polyurethane). The mechanical properties of this plastic were previously demonstrated by the manufacturer.

In essence, the "study" demonstrating the device meets the acceptance criteria (of being safe and effective) is the history of successful use of similar predicate devices and the demonstration that the proposed device shares the same fundamental technological characteristics and intended use as the predicate. This is a common approach for 510(k) clearances when a novel technology is not being introduced.

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