(55 days)
Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations.
Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices.
This document describes a medical device submission (K022206) for "Jensen Gold Foil," a pure gold direct filling gold foil used by dentists for various dental preparations. The submission is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to predicate devices, rather than requiring extensive new clinical trials.
Therefore, the customary information about acceptance criteria and a study proving device performance (as would be typical for software or complex medical devices with performance metrics like sensitivity/specificity) is not applicable in this context.
Here's why and what information is provided:
1. Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission states, "There are no standards for direct filling gold foil." Therefore, there are no specific numerical acceptance criteria like sensitivity, specificity, accuracy, or F1-score that would be applicable to AI or diagnostic devices.
- Reported Device Performance: Instead of numerical performance metrics, the "performance" of Jensen Gold Foil is based on its long-standing history of clinical use and material properties. The submission refers to:
- "centuries long clinical success of direct filling gold foil."
- "Gold foil is the reference standard for biocompatibility and longevity."
- A citation from "Skinner's Science of Dental Materials" states, "there can be no doubt that a properly inserted direct gold restoration is unsurpassed from the standpoint of service."
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. There was no formal "test set" or clinical study with a specific sample size conducted for this 510(k) submission. The clearance is based on substantial equivalence to existing devices and the historical clinical performance of the material itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. No ground truth was established by experts for a specific test set. The efficacy and safety are inferred from the general understanding and historical use of gold foil in dentistry, as supported by dental literature.
4. Adjudication Method:
- Not Applicable. No adjudication method was used as there was no test set requiring ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is a material device, not a diagnostic or AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. Standalone Performance Study:
- Not Applicable. This device does not have a "standalone algorithm only" performance as it is a physical dental filling material, not software.
7. Type of Ground Truth Used:
- Historical Clinical Consensus / Textbook Reference. The "ground truth" for the safety and effectiveness of Jensen Gold Foil is derived from:
- The "centuries long clinical success" of direct filling gold foil.
- Its status as the "reference standard for biocompatibility and longevity."
- Evidence cited from "Skinner's Science of Dental Materials," a fundamental textbook in dental materials.
8. Sample Size for the Training Set:
- Not Applicable. There was no "training set" in the context of an algorithm or AI model development. The manufacturing processes and material composition would be based on established dental metallurgy and quality control, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there was no training set, this question is not relevant. The "ground truth" regarding the material's properties and manufacturing would adhere to established scientific principles and industry standards for dental materials.
In summary: The Jensen Gold Foil 510(k) submission relies on the established safety and efficacy of direct filling gold foil as a known dental material, rather than presenting a new study with specific performance metrics and acceptance criteria. The FDA's clearance is based on its substantial equivalence to predicate devices and the long clinical history of the material itself.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.