(161 days)
S-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.
The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.
| Performance Test | Objective | Comparison Against | Reported Performance of S-Line™ |
|---|---|---|---|
| Wire Slot Torque test | Demonstrate stability to withstand torque force from wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Shear Bonding test | Demonstrate bond strength of brackets. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Bracket Removal Test | Demonstrate stability of brackets' de-bonding performance from the enamel surface with a plier. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Wire Drag Test | Measure friction between wire and bracket slot. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Door Pull-Out Test | Measure tensile force at the moment of fracture from the orthodontic wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Adhesive Strength Bonding Test | Study bonding of an adhesive to tooth structure or a bracket. | Not explicitly stated what it was compared against, likely also reference device. | Substantially equivalent |
| Biocompatibility Tests | ISO 10993-1, 10993-5, 10993-10 standards | ||
| Cytotoxicity | Assess for toxic effects on cells. | ISO 10993-5 | Non-cytotoxic |
| Mucosal Irritation | Assess for irritation to mucosal membranes. | ISO 10993-10 | None Irritation |
| Skin Sensitization | Assess for hypersensitivity reactions. | ISO 10993-10 | Do not show any hypersensitivity |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.
4. Adjudication Method for the Test Set:
This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance:
Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.
7. Type of Ground Truth Used:
The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.
8. Sample Size for the Training Set:
This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
§ 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.