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510(k) Data Aggregation
(10 days)
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.
The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.
The provided text describes a 510(k) submission for the BioMers Translucent Orthodontic Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance criteria for safety and effectiveness through extensive human studies. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert ground truth establishment, and adjudication methods is not typically part of a 510(k) summary for this type of device.
The submission relies on bench testing against established industry standards to demonstrate that the new device has comparable technical characteristics to the predicate device and does not raise new questions of safety or effectiveness.
Here's an attempt to answer the questions based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets and direct reported device performance against those targets. Instead, it indicates that the device was "designed and tested using the following standards" to assess its technical characteristics. The acceptance criteria are implicitly met if the device's performance, when tested according to these standards, is comparable to or deemed safe and effective given the predicate devices.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Implied by Substantial Equivalence Claim) |
|---|---|
| Flexural Properties: Compliance with ASTM D 790-03 (Standard test methods for flexural properties of unreinforced and reinforced plastics and electrical insulating materials) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 790-03, implying its flexural properties are acceptable and comparable to predicate devices. The document states "no known substantial differences... and any differences in technological characteristics do not raise issues of safety and effectiveness." |
| Tensile Properties: Compliance with ASTM D 3916-02 (Standard test method for tensile properties of pultruded glass fiber reinforced plastic rods) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 3916-02, implying its tensile properties are acceptable and comparable to predicate devices. |
| Water Absorption: Compliance with ASTM D 570-98 (Reapproved 2005) (Standard test method for water absorption of plastics) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 570-98, implying its water absorption characteristics are acceptable and comparable to predicate devices within the oral environment. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the "test set" in terms of clinical or human data. The testing mentioned refers to bench testing against engineering standards. Therefore, concepts like country of origin for clinical data or retrospective/prospective study design are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the submission relies on bench testing against engineering standards rather than expert-derived ground truth from clinical or image-based data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the submission relies on bench testing against engineering standards, not an adjudicated test set.
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
There is no mention of an MRMC comparative effectiveness study, nor is "AI" or "human readers" relevant to this device's submission. This is a physical orthodontic wire, not a diagnostic or AI-driven tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical orthodontic wire and does not involve an "algorithm" or standalone software performance in the way described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by its compliance with the technical specifications and performance characteristics outlined in the referenced ASTM standards. This is a materials science/engineering-based ground truth, not a clinical or expert-consensus ground truth. The primary ground for acceptance is substantial equivalence to legally marketed predicate devices, supported by bench test data.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
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