(65 days)
The Invisalign System is intended for the orthodontic treatment of malocclusion.
The Invisalign System (subject device) consists of removable orthodontic appliances (aligners), proprietary 3D software and attachment template. The system consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional mandibular advancement feature positions patients iaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. The Invisalign System is intended for treating dental and skeletal malocclusion in patients with Class I, II and III including Antoro-Posterior (A-P), vertical (open bite, transverse (narrow arch or jaw, crossbite), or inter-arch (spacing and crowding) correction at all severity levels. In some cases, surgical intervention, or addition of other appliances in addition treatment may be needed at the doctor's discretion.
The Invisalign System aligners consist of a series of customized orthodontic devices made from proprietary thermoformed polyurethane sheeting material. The first device in the series matches the patient's dentition in its current state and then each subsequent aligner stage has the shape of the dentition shifted gradually toward the final desired position. The aligners can accommodate use of tooth attachments and elastics (through use of precision cut outs or buttons or power arms). The system can also be ordered with additional aligner features such as precision cut outs, bite ramps, compliance indicators, and mandibular advancement features (MAF). MAF is also referred to as precision wings and is prescribed by the dental practitioner to position the lower jaw forward during correction of skeletal malocclusion. The subject device system of this Special 510(k), referred to as the Invisalign System, is a modification to the predicate device the Invisalign System with Mandibular Advancement Feature (MAF) (K181739, cleared on Oct 26, 2018) and is inclusive of both standard aligners and aligners with mandibular advancement feature.
The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align personnel-facing functions are termed 'Treat' internally. This internal facing software enables Align's computer-aided design (CAD) designers to create a treatment plan based on a doctor's prescription and inputs (e.g., dental scans). The treatment plans created using the Align personnel-facing software are then reviewed and approved by doctors before the aligners are manufactured. The doctors' reviews and approvals are exchanged via ClinCheck software (dental practitioner-facing software). Once the treatment plan is approved by the dental practitioner, the information is sent to the manufacturing facility for creation of the aligners.
When attachments are prescribed as part of the treatment plan, a disposable template is provided to assist the dental practitioner in positioning and forming the attachments from dental composite (sold separately). Attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite. During the first visit, the dental practitioner uses the template in bonding dental composite to the tooth surface to create attachments on the teeth. These attachments help create forces on the tooth which can assist in aligner retention or optimized aligner force system for tooth movement.
The provided document is a 510(k) premarket notification from the FDA for the Invisalign System. It outlines the regulatory clearance for the device based on its substantial equivalence to a predicate device.
Crucially, this document states that there were no proposed design changes and that the changes submitted were minor labeling updates. Therefore, no new performance data, clinical testing, or animal testing was required for this particular submission (K220287). The document explicitly states:
- "There are no proposed design changes in the scope of this pre-market notification. The proposed labelling changes do not trigger any performance testing as the changes are minor clarifications and additions that do not impact the current safety and effectiveness profile of the Invisalign System."
- "No animal or clinical testing was required to validate these labeling modifications."
Given this information, it is not possible to describe acceptance criteria or a study that proves the device meets actual performance criteria based on the provided text, as no such study was conducted for this specific 510(k) submission.
The information requested in your prompt (acceptance criteria, sample size, expert ground truth, MRMC studies, standalone performance, training set details) pertains to a typical performance study for a medical device. Since this 510(k) was based on "substantial equivalence" due to minor labeling changes and no design changes, these types of performance studies were not a part of this particular submission for the new clearance (K220287). The safety and effectiveness were considered established by the predicate device (K181739).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using only the provided text, as the text explicitly states no such studies were required or conducted for this specific submission.
§ 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.