Search Results

Porta Reflex is a gold-platinum 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 Reflex can be veneered with suitable dental ceramics as well as with dental-composites.

Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), 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 removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Reflex 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 Reflex 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.

Here's an analysis of the provided 510(k) summary for the Porta Reflex device, focusing on the acceptance criteria and study information:

This document, K040672 for "Porta Reflex," is a 510(k) Premarket Notification. For this type of device (a dental alloy), 510(k)s typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that one might see for AI/ML-based diagnostic devices.

Therefore, the structure of the request for acceptance criteria and study data needs to be interpreted in the context of this specific device and filing type. The "study" here is primarily a demonstration of compliance with established standards and comparison to a predicate, not a clinical effectiveness trial in the way that an AI diagnostic would have.

Acceptance Criteria and Reported Device Performance

Given that this is a dental alloy and a 510(k) submission, the "acceptance criteria" are typically compliance with recognized standards and demonstration of properties comparable to a predicate device, rather than specific sensitivity/specificity targets.

Study Information

For this type of device, the "study" is more akin to engineering and materials testing, and a comparison to an existing predicate, rather than a clinical trial with human subjects testing AI performance.

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document does not specify sample sizes or data provenance for any specific mechanical or material property tests. This information would typically be detailed in the full submission, which is not provided, but often isn't explicitly summarized in the 510(k) summary itself for materials devices. The "tests" here are standard material characterization tests, likely conducted in a lab setting, not on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable as this is not a diagnostic device involving expert interpretation of medical images or patient data. The "ground truth" would be material properties established via standardized lab measurements.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This is not a clinical study requiring adjudication of diagnoses.

4. 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 not an AI/ML device, nor a diagnostic device that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is not an algorithm/AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for this device would be established through laboratory material characterization tests conforming to ISO 9693 and other relevant engineering standards. These tests measure properties like tensile strength, corrosion resistance, biocompatibility, etc.

7. The sample size for the training set

   • Not applicable. There is no AI/ML model for which to define a training set. If interpreted in a broader sense of "development data," it would refer to the materials used in R&D and optimization, but this is not specified.

8. How the ground truth for the training set was established

   • Not applicable. There is no AI/ML model for which to define a training set. The "ground truth" for development would be the target material properties and performance characteristics defined by engineering specifications and industry standards.

Ask a specific question about this device