(87 days)
Adhesive for luting ceramic and metal orthodontic brackets
Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
The provided document (K072978) is a 510(k) summary for a dental adhesive system (Tender Ortho Bond - Ena Bond - Ena Etch). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing that adheres to recognized standards. It does not contain details of a clinical study or AI performance evaluation as requested in the prompt.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, specifically in the context of an AI device and clinical study, cannot be extracted from this document.
However, I can provide information based on what is available in the document regarding the device's performance evaluation against a standard.
1. Table of Acceptance Criteria and Reported Device Performance
The document references "ISO 4049:2000 Dentistry - Polymer - Based Filling, Restorative and Luting materials" as the standard followed for evaluating the device. While the exact acceptance criteria from ISO 4049:2000 are not explicitly detailed in the provided text, the submission states that the standard was followed. The implied "reported device performance" is that the device met the requirements of this standard for its intended use, otherwise, substantial equivalence would not have been granted.
| Acceptance Criterion (from ISO 4049:2000 - Implied) | Reported Device Performance |
|---|---|
| Adhesion/Bond Strength (for luting orthodontic brackets) | Complied with ISO 4049:2000 requirements for polymer-based luting materials. |
| Polymerization characteristics (e.g., degree of cure, working time) | Complied with ISO 4049:2000 requirements. |
| Biocompatibility (e.g., cytotoxicity) | Cytotoxicity tests appear in Appendix III (details not provided in this extract), implying satisfactory results. |
| Other physical/chemical properties as per ISO 4049:2000 | Complied with ISO 4049:2000 requirements. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a clinical study or AI evaluation. The performance evaluation would have been conducted on laboratory samples according to the specifications of ISO 4049:2000. No information on sample sizes for these lab tests or data provenance (country of origin, retrospective/prospective) is provided in the publicly available summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This document does not describe a study involving expert-established ground truth for a test set. The validation is based on adherence to an engineering standard (ISO 4049:2000).
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not mention an MRMC study or any comparison of human readers with or without AI assistance. The device is a dental adhesive, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. The device is a dental adhesive. This concept is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is compliance with the ISO 4049:2000 standard for "Dentistry - Polymer-Based Filling, Restorative and Luting materials." This standard dictates the methods and criteria for evaluating the physical, chemical, and biological properties of such materials. The specific tests (e.g., bond strength, cytotoxicity) described within the standard would serve as the "ground truth" for performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no training set in that context. The "training set" for the device's development would refer to the materials and formulations developed and refined prior to final testing, but no specific sample sizes for this are provided in the regulatory summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable for an AI training set. For the development of the adhesive material, the "ground truth" would have been established through iterative laboratory testing and material science principles, aiming to meet desired performance characteristics and ultimately comply with ISO 4049:2000. These details are not part of the 510(k) summary.
§ 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.