(113 days)
DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
The device will be patient-specific 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 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 teeth from the previous aligner. 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 provided text is a 510(k) Summary for the DynaFlex Clear Aligner. It primarily demonstrates substantial equivalence to predicate devices and does not describe AI/ML device performance or a clinical study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device.
The document states:
- "Bench testing of the Aligners has not been performed; however, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics and material to demonstrate that the preformed aligner provides reasonable assurance of effectiveness." (Page 5)
- "The DynaFlex Clear Aligner passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device." (Page 5)
- "Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the doctors' requirements. The output and work model and aligner were tested and compared. DynaFlex Clear Aligners met the specifications of this testing." (Page 5)
- "DynaFlex has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the thermoformed plastic has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required to demonstrate substantial equivalence." (Page 5)
This 510(k) summary focuses on demonstrating substantial equivalence based on material, design, manufacturing process, and intended use to existing predicate devices (Clear Image™ Aligner and Clear Correct). It does not involve AI/ML performance, diagnostic accuracy, or a clinical study in the typical sense of evaluating an AI model. Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria and reported device performance (in the context of AI metrics).
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or related effect sizes.
- Standalone performance (algorithm only).
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document is for a physical medical device (orthodontic aligner), not an AI/ML-powered diagnostic or assistive device. The "performance characteristics" detailed relate to material safety, manufacturing quality, and physical properties, not diagnostic or clinical accuracy determined by an AI algorithm.
§ 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.