(71 days)
Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work .
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), 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 to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided 510(k) summary for the Portadur P 2 device does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/medical device performance evaluation. The summary is for a dental casting alloy and focuses on its material properties, biocompatibility, and intended use as a medical device, rather than an AI or image-based diagnostic tool.
Therefore, many of the requested categories in your prompt are not applicable to the provided document. I can, however, extract relevant information about the device itself from the text.
Here's an analysis based on the provided text, indicating where information is present or absent for your specific questions:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document states that the device "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not specify the numerical acceptance criteria for various physical or chemical properties defined by ISO 1562, nor does it present a table of the device's performance against such criteria. It generally describes the device as being "extra-hard" and "highly corrosion resistant."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/diagnostic device, and no test set in that context is discussed.
3. 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. This is not an AI/diagnostic device, and no ground truth establishment by experts is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
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 (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a dental alloy would relate to its physical and chemical properties as measured by standardized tests, not diagnostic accuracy. The text refers to compliance with ISO 1562.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Information from the Provided Text:
- Trade Name: Portadur P 2
- Manufacturer: Wieland Edelmetalle GmbH & Co. (Germany)
- Device Type: Extra-hard gold casting alloy
- Composition: High noble metal content (75.1%)
- Intended Use: For dental technicians to fabricate dental restorations.
- Specific Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
- Key Properties: Highly corrosion resistant, excellent biocompatibility.
- Standards Met: ISO 1562, European directive 93/42/ECC concerning medical devices.
- Predicate Device: Aurofluid 3 (K911539)
- Regulatory Class: II (under 21 CFR 872.3060, Alloy, Gold Based, For Clinical Use)
The document is a 510(k) summary demonstrating substantial equivalence to a predicate device, which primarily involves comparing material specifications, intended use, and general performance claims (like biocompatibility and corrosion resistance) to established standards and the predicate device. It does not involve a clinical study or performance evaluation as would be typical for an AI-based diagnostic device.
§ 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.