(267 days)
The Bioliner™ is an aligner system indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
The Bioliner™ aligner system is used for treatment of misalignment and malocclusion of permanent teeth by use of clear plastic aligners. The Bioliner™ aligner system is a sequential set of removable aligners prescribed by a dentist that are custom made for a specific patient.
Each Bioliner™ sequential aligner introduces subtle changes in the position of the teeth from the previous aligner. Each Bioliner™ is fabricated from 1.0mm thermoplastic. For each patient, the Bioliner™ will be designed by a Five Star Orthodontic Laboratory & Supply, Inc. technician utilizing 3Shape (K152086) orthodontic validated software and tooth movement recommendations from the prescribing dentist. Once fabricated, the Bioliner™ aligners are provided to the dentist, and over a period of time, the dentist provides the next sequential aligner to the patient in order to move the teeth to the desired final position.
The aligners are removable at any time and treatment may be discontinued at any time. The Bioliner™ aligners are a non-sterile, single use device.
The provided text is a 510(k) Pre-Market Notification from the FDA regarding the Bioliner™ orthodontic aligner system. It details the device, its intended use, a comparison to a predicate device, and summaries of testing.
However, the document explicitly states:
"Summary of Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Bioliner™ to the predicate device."
"Summary of Non-Clinical Testing: Biocompatibility testing was performed for the Bioliner™ aligners in accordance with ISO 10993-1 and its applicable parts. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required."
Therefore, based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance (as no clinical or mechanical performance testing was performed for this 510(k) submission).
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
- If a standalone (algorithm only) performance was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) submission for the Bioliner™ relied on demonstrating substantial equivalence to a predicate device and existing clearances for its materials and manufacturing software, rather than new clinical or detailed performance studies.
§ 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.