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Ormco™ EtchFree Bonding Primer is a bonding primer intended to bond orthodontic appliances such as metal brackets, ceramic brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement without etching.
Ormco™ EtchFree Adhesive is a light-curing adhesive that is intended to be used for the attachment of orthodontic appliances to teeth such as metal bracket, ceramic brackets, and aligner attachments.
The Ormco™ Bonding System consists of a primer, a sealant, an adhesive, and bonding accessories.
· Ormco™ Bonding Primer is intended to bond orthodontic appliances such as metal brackets, and aligner attachments to enamel, in conjunction with an orthodontic sealant/enhancer, such as Ormco's Ortho Solo™ and an adhesive/cement. The primer is a clear liquid that conditions the surface of the application of a bonding sealant/enhancer. Ormco Bonding Primer is designed to be used as a system along with Ortho Solo and Ormco" Bonding Adhesive. The primer is offered in single-use vials which will be sold in kits and separately.
· Ormco™ Adhesive is a light-curing composite that is intended to be used with metal and ceramic brackets for orthodontic treatment and can also be used as aligner attachment. It is a convenient off-white paste providing aesthetics when used as aligner attachments or beneath a bracket. The adhesive is designed to be used as a system along with Ormco Bonding Primer and Ortho Solo. The adhesive is offered in syringes for multi-patient use, which will be sold in kits and separately.
This document describes the Ormco™ EtchFree Bonding System, comprising the Ormco™ EtchFree Bonding Primer and Ormco™ EtchFree Adhesive, and its substantial equivalence to predicate devices. The information provided focuses on non-clinical performance bench testing rather than clinical studies related to human reader performance or detailed AI-specific metrics.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. It lists the international and FDA-recognized consensus standards against which non-clinical performance bench testing was conducted. It generally states that "All results were deemed acceptable."
However, based on the mentioned tests, we can infer the areas of performance evaluated:
| Performance Area | Acceptance Criteria (Inferred from standards) | Reported Device Performance (General Statement) |
|---|---|---|
| Mechanical Strength | Conformance to ISO 29022: Dentistry - Adhesive - Notched-edge shear bond strength test | "All results were deemed acceptable." |
| Adhesion to Tooth Structure | Conformance to ISO 11405:2015 Dentistry - Testing of Adhesion to Tooth Structure | "All results were deemed acceptable." |
| Biocompatibility | Conformance to various ISO/ADA/ANSI standards (e.g., ISO 7405, 10993-3, -5, -11, -1) for Cytotoxicity, Acute System Toxicity, Sensitization, Irritation, Mutation, Genotoxicity | "Biocompatibility testing was completed... All results were deemed acceptable." |
| Material Properties | Evaluation of properties like Knife Shear, Hardness, Viscosity, Working Time | "Several tests were carried out, such as Knife Shear, Hardness, Viscosity and Working Time, to name a few. All results were deemed acceptable." |
| MR Safety Marking | Conformance to ASTM F2503-23: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | (Not explicitly stated if tested, but a standard followed) |
| Aging (Shelf-life) | Conformance to ASTM F1980-16: Standard Guide for Accelerating Aging of Sterile Barrier Systems for Medical Devices | (Not explicitly stated if tested, but a standard followed) |
| Labeling/Symbols | Conformance to ISO 15223-1: Medical devices - Symbols to be used with information to be supplied by the manufacturer | (Not explicitly stated if tested, but a standard followed) |
| Risk Management | Conformance to ANSI AAMI ISO 14971:2019: Medical devices - Applications of risk management to medical devices | (Not explicitly stated if tested, but a standard followed) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical performance bench testing. It does not mention clinical studies or human test sets. Therefore, details regarding sample size for test sets, country of origin, or retrospective/prospective data are not applicable in this context. The "test set" refers to materials or samples used in laboratory bench tests. The specific number of samples for each bench test (e.g., how many specimens for shear bond strength) is not provided.
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 document describes non-clinical bench testing of a dental adhesive system. There is no mention of experts or ground truth establishment in the context of human assessment or interpretation of results for a test set. The "ground truth" for these tests would be the measurement results against established scientific standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a human-centric test set requiring adjudication in the provided text.
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
This is not applicable. The device described is a dental adhesive system, not an AI-powered diagnostic tool or image analysis system. There is no mention of AI assistance or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench tests, the ground truth is established by the scientific and engineering principles and methodologies outlined in the referenced international and FDA-recognized consensus standards (e.g., ISO 29022 for shear bond strength, ISO 11405 for adhesion, ISO 10993 series for biocompatibility). The "truth" is whether the material properties or biological responses meet the specifications or thresholds defined by these validated tests.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI model or algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (physical product, not AI).
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.