(70 days)
Porta Maximum is a universal gold-based dental 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 . Porta Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
Porta Maximum is an extra-hard universal alloy with high contents of noble metals (83%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Maximum 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. Porta Maximum can be veneered with low-fusing dental ceramics with high expansion 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 "Porta Maximum." This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to existing, legally marketed devices. It does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI algorithms.
Instead, the submission for "Porta Maximum" focuses on its physical and chemical properties and its intended use, asserting its compliance with international standards (ISO 9693) and European directives. The "acceptance criteria" here are essentially the requirements for substantial equivalence to a predicate device and adherence to established material standards, rather than performance metrics from a clinical study.
Therefore, the requested information elements related to a study (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of regulatory submission because an efficacy study of this nature was not performed or required for this type of device.
Below is a table summarizing the "acceptance criteria" as implicitly understood for a dental alloy of this nature, and the reported characteristics of the Porta Maximum, drawing from the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit) | Reported Device Performance (Porta Maximum) |
|---|---|---|
| Substantial Equivalence | Equivalent to legally marketed predicate device (Argistar Bio 75PF, K955973) in terms of indications for use and safety/effectiveness. | Determined substantially equivalent by FDA (K012835). |
| Material Composition | High noble metal content for dental alloys. | 83% noble metals. |
| Intended Use Compatibility | Suitable for a range of dental restorations. | Indication for inlays/onlays, crowns, partial crowns, short span bridges, long span bridges, removable partials. Also suitable for telescopic and milling work. |
| Veneering Compatibility | Compatible with common dental veneering materials. | Can be veneered with low-fusing dental ceramics with high expansion and dental composites. |
| Biocompatibility | Non-toxic and biologically safe for oral use. | Highly corrosion resistant and excellent biocompatibility. |
| Regulatory Compliance | Meets relevant international and regional material standards. | Fully complies with ISO 9693. Fulfills essential requirements of European directive 93/42/ECC concerning medical devices. |
| Physical Properties | "Extra-hard" for durability and functional performance. | Described as an "extra-hard universal alloy." |
| Aesthetic Properties | Provides good basis for aesthetic restorations. | Golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations. |
| Specific Ingredient Concerns | Free of undesirable or allergenic components (e.g., copper for certain applications). | Free of copper, therefore suitable for telescopic and milling work. |
Study Details (Not applicable for this type of device submission)
- Sample size used for the test set and the data provenance: Not applicable. This submission is for a dental alloy, not a device requiring a clinical test set in the traditional sense. The "testing" referred to would be material characterization tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are established through laboratory testing and compliance with standards, not expert consensus on clinical cases.
- Adjudication method for the test set: Not applicable.
- 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 not an AI or diagnostic tool that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device type would be established by material science standards, lab-based physical and chemical tests (e.g., tensile strength, corrosion resistance, composition analysis), and biocompatibility assessments, rather than clinical outcomes or expert consensus on patient data.
- The sample size for the training set: Not applicable. This device is not a machine learning model.
- 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.