(70 days)
BioPorta G is a gold-platinum ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. BioPorta G can be veneered with suitable dental ceramics as well as with dentalcomposites.
BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (97 %) intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work. BioPorta G is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. BioPorta G can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided text is a 510(k) Premarket Notification for a dental alloy named BioPorta G. This type of notification is for medical devices that are substantially equivalent to a legally marketed predicate device, and it typically does not involve studies demonstrating performance against acceptance criteria in the same way a novel device might.
Instead, the submission focuses on demonstrating that the new device (BioPorta G) is substantially equivalent to a previously cleared device (V-Gnathos Plus, K952122) in terms of its materials, intended use, and general performance characteristics. The primary "study" supporting this type of submission is often material characterization and comparison to recognized standards, rather than clinical trials with patient outcomes.
Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific 510(k) submission for a dental alloy.
Here's an analysis based on the information provided, highlighting the relevant sections and explaining why others are not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (dental alloy), "acceptance criteria" are typically defined by compliance with international standards and material properties expected for such alloys. The document states compliance with ISO 9693.
| Acceptance Criteria (Implied by Standard Compliance & Predicate Comparison) | Reported Device Performance |
|---|---|
| Material Composition: Gold-platinum ceramic alloy | BioPorta G: "...extra-hard dental alloy with high contents of gold and platinum (97 %)..." (Section 5, Device Description) |
| Intended Use: Fabrication of dental restorations (inlays/onlays, crowns, bridges, partials); telescopic and milling work. | BioPorta G: "It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work." (Section 5, Device Description) |
| Corrosion Resistance: High | BioPorta G: "BioPorta G is highly corrosion resistant..." (Section 5, Device Description) |
| Biocompatibility: Excellent | BioPorta G: "...has an excellent biocompatibility." (Section 5, Device Description) |
| Compliance with Standards: ISO 9693, European directive 93/42/ECC | BioPorta G: "It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." (Section 5, Device Description) |
| Veneer Compatibility: Compatible with suitable dental ceramics and composites. | BioPorta G: "BioPorta G can be veneered with suitable dental ceramics and with dental composites..." (Section 5, Device Description) |
| Substantial Equivalence to Predicate Device: V-Gnathos Plus (K952122) | FDA Determination: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (Page 2) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For material characterization studies for dental alloys, testing is performed on material samples rather than "test sets" of patient data. The document does not specify the number of material samples tested.
The data provenance would be related to the manufacturer's internal testing and compliance with the mentioned standards (ISO 9693), which would typically be conducted in a laboratory setting. There is no indication of country of origin for specific "test data" beyond the manufacturer's location (Germany).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and submission. Ground truth in this context would be defined by established material science principles and international standards, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in clinical assessments or interpretations, which are not part of this 510(k) submission for a dental alloy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported. These studies are typically conducted for diagnostic imaging devices or other technologies where human interpretation plays a role and AI assistance might improve performance. This device is a material, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study was not done or reported. This concept applies to AI algorithms, which are not relevant to a dental alloy.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on:
- Material Science Principles and Specifications: The inherent properties of the alloy (composition, physical properties).
- International Standards: Compliance with ISO 9693.
- Biocompatibility Standards: Evidence of excellent biocompatibility, likely demonstrated through standard in vitro and/or in vivo material testing (though details are not provided in this summary).
- Predicate Device Equivalence: The attributes of BioPorta G are compared to the known and accepted properties of the predicate device, V-Gnathos Plus.
8. The Sample Size for the Training Set
This information is not applicable. This device is a material, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.