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BioPorta G is a gold-platinum alloy that can be used by dental technicians to fabricate der 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 dental-composites.

In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G are joined to form dental restorations.

BioPorta G is a gold-platinum ceramic alloy with high contents of noble metals (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 suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires.

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 documentation is a 510(k) premarket notification for a dental alloy named "BioPorta G". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement with AI.

Therefore, the requested information regarding acceptance criteria derived from a performance study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not applicable to this document.

The 510(k) summary (and accompanying FDA letter) indicates a different kind of "acceptance criteria":

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) device is demonstrating substantial equivalence to a predicate device that is already legally marketed. This is achieved by comparing the new device's indications for use, technological characteristics, and performance data (often mechanical, chemical, and biological properties for materials like dental alloys) to the predicate device.
• Compliance with Standards: The device is stated to "fully comply to the international standard ISO 9693" and "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." These standards and directives serve as "acceptance criteria" for the material properties and safety of the alloy.

Based on the provided information, I can summarize what is available regarding "acceptance" in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device "Performance":

Non-Applicable Information for this 510(k) Document:

The following points are based on typical performance studies for diagnostic devices, particularly those involving AI or image analysis. This 510(k) is for a material, a dental alloy. Therefore, these requested details are not present in this submission.

• 2. Sample size used for the test set and the data provenance: Not applicable. Performance data would relate to material properties, not a dataset in the typical sense of diagnostic algorithms.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a material would involve laboratory testing and chemical analysis, not expert consensus on images.
• 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 is for a material, not a diagnostic or AI-assisted device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: For a material, ground truth is typically established through standardized physical, chemical, and biological testing methods (e.g., tensile strength, corrosion tests, biocompatibility assays per ISO standards), not expert consensus, pathology, or outcomes data in the diagnostic context. The document mentions compliance with ISO 9693, implying such testing was performed.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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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.

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.

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