(69 days)
Precious Alloy for use in Crown and Bridge Dental Restorations.
Stengold 1 is a Yellow Crown and Bridge Alloy.
The provided FDA 510(k) summary for the "Sterngold 1" dental alloy does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/imaging devices.
This document describes a "Special 510(k): Abbreviated 510(k)" for a dental alloy, not an AI or imaging device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting performance studies with detailed acceptance criteria as would be expected for a diagnostic AI tool.
Therefore, many of the requested categories are not applicable to this submission.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The submission is for a dental alloy, which relies on demonstrating conformity with FDA guidance for dental alloys and comparison to predicate devices, rather than performance metrics like sensitivity, specificity, or image quality against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. There is no "test set" in the context of an AI/imaging device described. The submission focuses on the material properties and intended use of a dental alloy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth establishment by experts for a test set is not relevant for a dental alloy submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not applicable. This is not an AI-assisted device.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
Not applicable. The "ground truth" for a dental alloy would relate to its material properties, biocompatibility, and mechanical performance, which are assessed against recognized standards and predicate device data, not through expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not a machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the K022252 Submission for Sterngold 1 Dental Alloy:
The K022252 submission for Sterngold 1 is an Abbreviated 510(k) for a "Yellow Crown and Bridge Alloy." This pathway is used to demonstrate substantial equivalence to legally marketed predicate devices by conforming to recognized standards and guidance documents.
- Acceptance Criteria (Implicit): Conformance to FDA's "Guidance Document for the Preparation of Premarket Notifications [510(k)'s] for Dental Alloys" and equivalence in material properties and safety/effectiveness to predicate devices (Harmony Medium, Monogram II).
- Study That Proves the Device Meets Acceptance Criteria: The submission itself, by providing information to demonstrate conformity with the FDA's guidance document for dental alloys, serves as the "study." This typically involves presenting data on material composition, mechanical properties, and biocompatibility, as well as a comparison to the predicate devices. The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, Sterngold 1 has been shown to be safe and effective for its intended use."
The FDA's review resulted in a determination of substantial equivalence, allowing the device to be marketed. This regulatory pathway does not necessitate the types of performance studies or ground truth establishment described in the prompt, which are more relevant for diagnostic devices, particularly those incorporating AI.
§ 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.