(47 days)
Porta OP Solder M-1 is intended for use as a primary solder in operations in which dental alloy(s) parts are joined to form a dental restoration. lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.
Porta OP Solder M-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Platinum and Silver: 90,0%). Porta OP Solder M-1 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as primary solder for dental casting alloys with appropriate melting ranges and compositions, especially BioPortadur, Portadur P 2, Auropal 1, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta OP Solder M-1 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
This document is a 510(k) Premarket Notification for a dental brazing alloy called "Porta OP Solder M-1." This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance testing that would typically involve AI.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this 510(k) submission for a conventional dental material.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for this type of 510(k) submission. Acceptance criteria here revolve around meeting the properties of a legally marketed predicate device and applicable international standards, not against performance metrics for an AI/software device.
The device "Porta OP Solder M-1" is stated to:
- Be a yellow alloy with high contents of precious metals (Gold, Platinum, and Silver: 90.0%).
- Be suitable for use as a filler material in operations where dental alloy parts are joined to form a dental restoration (e.g., bridges).
- Be intended as primary solder for specific dental casting alloys (BioPortadur, Portadur P 2, Auropal 1, Auropal 60, and Auropal 50).
- Be highly corrosion resistant.
- Fully comply with international standard ISO 9333.
- Fulfill the essential requirements of the European directive 93/42/ECC concerning medical devices.
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a test set of data as understood in AI/software development. The evaluation focuses on material properties and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/software (e.g., expert consensus on images) is not relevant for this material submission.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This device is a dental brazing alloy, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical material, not an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/software. For a dental alloy, "ground truth" would relate to validated material testing methods (e.g., elemental analysis, mechanical testing, corrosion resistance testing) against established standards (ISO 9333 in this case) and comparison to a predicate device's properties.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.