(97 days)
DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state. DynaFlex EZ-Align® is for prescription only.
DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state.
The device will be custom made for each patient and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.
Aligners are fabricated from .030 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aliener. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.
Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.
The DynaFlex® EZ-Align® device is a series of clear, lightweight, plastic retainers designed to correct minor anterior tooth misalignment. The available documentation does not describe a study with explicit acceptance criteria or reported device performance metrics in the way one might expect for an AI/CADe device. Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed devices.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or device performance metrics (e.g., success rates of tooth movement) are stated in the document.
The "Performance Characteristics" section explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."
Instead of performance metrics against acceptance criteria, the document relies on comparing the device's technological characteristics and intended use to predicate devices. The implicit acceptance criterion is that the device is substantially equivalent to the predicate devices, thereby ensuring comparable safety and effectiveness.
The table below summarizes the comparison of characteristics for substantial equivalence. While not "performance," these are the aspects evaluated for acceptance.
| Characteristic | DynaFlex® EZ-Align® | ALLESEE ORTHODONTIC APPLIANCES (RED, WHITE & BLUE®) | Specialty Appliances Works, Inc. (Clear Image™Aligners) | ClearCorrect, Inc. (ClearCorrect™) |
|---|---|---|---|---|
| Intended Use | Correct minor (1.5mm or less) anterior tooth misalignment in patients with permanent dentition by moving teeth progressively. | Correct minor to intermediate anterior tooth mal-alignments in patients with permanent dentition by moving teeth progressively. | Treating a patient's anterior teeth, involving relatively minor orthodontic tooth movements. | Treatment of tooth malocclusion in patients with permanent dentition. |
| Mechanism of Action | Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited). | Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited). | Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited). | Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited). |
| Material | Thermoformed polycarbonate (Plastic) | Thermoformed polycarbonate (Plastic) | Thermoformed polycarbonate (Plastic) | Thermoformed polycarbonate (Plastic) |
| Sterility | No | No | No | No |
| Single Use (Patient) | Yes (i.e., multiple use by the same patient) | Yes (i.e., multiple use by the same patient) | Yes (i.e., multiple use by the same patient) | Yes (i.e., multiple use by the same patient) |
| Worn at Night | Yes | Yes | Yes | Yes |
| Patient Population | Patient with Permanent Dentition | Patient with Permanent Dentition | Patient with Permanent Dentition | Patient with Permanent Dentition |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study demonstrating device performance is described. The submission relies on scientific literature and the established safety and effectiveness of predicate devices. Therefore, these details are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no described test set or ground truth establishment process is provided. The evaluation is based on a comparison of device characteristics rather than a clinical outcome study requiring expert-derived ground truth.
4. Adjudication Method
Not applicable, as no described test set or adjudication process is provided.
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
Not applicable. This device is a sequential aligner for physical tooth movement, not an AI/CADe product intended to assist human readers (e.g., radiologists) in diagnostic tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical orthodontic appliance, not an AI algorithm. Its function inherently involves human intervention (dentist prescription, patient use).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for acceptance is "substantial equivalence" to predicate devices, focusing on materials, design, intended use, and mechanism of action, rather than a direct performance evaluation against a defined ground truth for a specific medical outcome. The "ground truth" in this context is the regulatory acceptance of the predicate devices.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" presented is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, DynaFlex, did not conduct a new clinical trial or bench testing to establish the superior or equivalent performance of the EZ-Align® device in terms of clinical outcomes (e.g., percentage of successful tooth alignment).
Instead, they demonstrated substantial equivalence by detailing how the EZ-Align® device shares the same:
- Intended Use: Correcting minor anterior tooth misalignment in patients with permanent dentition (with specific thresholds for crowding).
- Technological Characteristics: Made from thermoformed polycarbonate plastic, custom-fabricated, non-sterile, single-patient multiple-use, worn at night, and applies force through intentional distortion of the plastic.
- Mechanism of Action: Basic mechanics follow conventional orthodontics, applies simple force for tipping, rotation, extrusion, and intrusion (with limited extrusive force).
- Materials: Thermoformed polycarbonate.
- Patient Population: Patients with permanent dentition.
The submission argues that because these key characteristics are "essentially identical" to those of multiple FDA-cleared predicate devices (Allesee Orthodontic Appliance Inc. - Red, White & Blue (K040874), Specialty Appliance Works, Inc. - Clear Image™ Aligner (K071970), and Clear Correct, Inc. - Clear Correct (K082556)), the EZ-Align® device can be presumed to be as safe and effective as those existing devices. The FDA's 510(k) clearance confirms this finding of substantial equivalence.
§ 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.