(290 days)
The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.
The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing.
The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity.
The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.
The provided document is a 510(k) summary for an Orthodontic Appliance. It details the device's indications for use, its description, comparison to a predicate device, and non-clinical performance testing. However, it explicitly states that no clinical testing was required or performed to support the device's clearance.
Therefore, many of the requested details regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as such a study was not conducted for human performance. The focus of the provided document is on demonstrating substantial equivalence to a predicate device through non-clinical means (material properties, biocompatibility, and software V&V for ordering/processing).
Here's what can be extracted based on the information provided:
Acceptance Criteria and Device Performance (Non-Clinical)
Since no clinical study was performed, the "device performance" relies on non-clinical tests and comparison to a predicate. The acceptance criteria essentially stem from demonstrating that the subject device is comparable to the predicate device in terms of performance characteristics.
| Acceptance Criteria (What was tested for) | Reported Device Performance (Met, or comparable to predicate) |
|---|---|
| Physical and Mechanical Properties: | The document states: "The performance testing for the subject device was performed and showed that the subject device meets all internal final inspection standard, while the physical and mechanical properties as well as the biocompatibility of the thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials." |
Specific tested items included:Appearance and surface characteristicsDimensionspH valueElasticity variableVolume weightWater sorptionSolubilityThe comparative testing between the proposed and predicate device for these properties was conducted to demonstrate substantial equivalence. The implication is that the subject device's performance aligns with or is sufficiently similar to the predicate device and established material properties. |
| Biocompatibility (ISO 10993 Standards): | The document states: "Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of the tests met the requirements of the study protocols..."
Specific tests conducted:Cytotoxicity (ISO 10993-5)Skin Sensitization (ISO 10993-10)Intracutaneous Reactivity (ISO 10993-10)Subchronic systemic toxicity (ISO 10993-11)Genotoxicity (ISO 10993-3)The results indicated the device met the requirements, supported by the long history of safe use of the thermoplastic material and the predicate device's information. |
| Software Verification & Validation: | The document states: "Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern." This indicates that the software was tested and verified to perform its intended functions related to device ordering and processing, meeting the requirements for its risk classification. |
Study Details (Based on the document's claims of no clinical testing required)
Many of these categories are not applicable (N/A) because the submission explicitly states:
"The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device."
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Sample sizes used for the test set and the data provenance:
- Clinical Test Set: N/A (No clinical test set was used for human performance evaluation).
- Non-Clinical Test Set: Not specified in terms of sample numbers, but tests were performed on material samples and the device itself (e.g., for dimensions, appearance, physical/chemical properties). Data provenance is from Shandong Huge Dental Material Corporation's internal testing and material suppliers' data.
- Biocompatibility Tests: Sample sizes for ISO 10993 tests are not explicitly mentioned in this summary, but these are standard lab tests performed on material extracts or samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical ground truth was established as no clinical study was performed for this 510(k)).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication).
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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: N/A (No MRMC study was performed as no clinical study was conducted, and the device is a physical appliance, not an AI-based diagnostic tool for human readers).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (The device is a physical appliance, not an algorithm, and no standalone clinical performance was evaluated). Non-clinical standalone tests were performed as detailed in the table above (physical/mechanical properties, biocompatibility).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No clinical ground truth as no clinical study for human performance was conducted. For non-clinical tests, "ground truth" would be the established ISO standards and material specifications).
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The sample size for the training set: N/A (The device is a physical orthodontic appliance, not a machine learning model. Therefore, there's no "training set" in the context of an AI/ML device). The design of the appliance is based on 3D printed data generated by "Clear Aligner Design Software", but this itself is part of the manufacturing process, not a training set for an AI algorithm.
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How the ground truth for the training set was established: N/A (No training set for an AI/ML model).
§ 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.