(89 days)
Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Duo Pal 6 can be veneered with suitable dental ceramics as well as with dental composites.
Duo Pal 6 is a dental alloy with high contents of noble metals (81,5%) intended for dental technicians to fabricate dental restorations. it has an indication which ranges from 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. Duo Pal 6 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. Duo Pal 6 can be veneered with suitable dental ceramics and with dental composites.
The provided text is a 510(k) summary for a dental alloy named "Duo Pal 6". It does not describe a study involving acceptance criteria and device performance in the way typically expected for an AI/software as a medical device (SaMD). Instead, it focuses on the material's properties and equivalence to a predicate device.
Here's an analysis based on the information provided, highlighting the aspects relevant to your request while acknowledging the device's nature:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that Duo Pal 6 "fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." ISO 9693 is a standard for dental ceramic-to-metal bonding alloys.
While specific acceptance criteria values (e.g., tensile strength, corrosion resistance thresholds) and measured performance values for Duo Pal 6 are not explicitly listed in a comparative table within the provided text, the statement of compliance implies that these criteria were met.
If we were to infer, the acceptance criteria would be derived from ISO 9693 and the essential requirements of Directive 93/42/ECC. The reported performance is that the device "fully complies" with these standards.
| Acceptance Criterion (Inferred from compliance statements) | Reported Device Performance |
|---|---|
| Compliance with ISO 9693 (Dental ceramic-to-metal bonding alloys) | Duo Pal 6 fully complies with ISO 9693. |
| Fulfillment of essential requirements of European Directive 93/42/ECC (Medical Devices) | Duo Pal 6 fulfills the essential requirements of Directive 93/42/ECC. |
| High corrosion resistance | Duo Pal 6 is highly corrosion resistant. |
| Excellent biocompatibility | Duo Pal 6 has excellent biocompatibility. |
| Suitability for specific dental restorations (crowns, bridges, partials, telescopic/milling work) | Indicated for crowns, long span bridges, removable partials, telescopic and milling work. |
| Compatibility with veneering materials (dental ceramics, composites) | Can be veneered with suitable dental ceramics and dental composites. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a study with a "test set" in the context of data for an AI/SaMD. The evaluation for Duo Pal 6 likely involved laboratory testing of material samples to demonstrate compliance with ISO 9693 and biocompatibility. The sample size for such material testing is not specified in this summary, nor is the provenance of "data" (e.g., country of origin, retrospective/prospective) as it would apply to clinical data. The product is manufactured by Wieland Edelmetalle GmbH & Co. in Pforzheim, Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. Ground truth, in the context of material science and compliance with a standard like ISO 9693, would be established through defined test methodologies and measurements, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device is a material, not a diagnostic or AI-driven decision support system requiring adjudication of interpretations.
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 not an AI/SaMD device.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI/SaMD device.
7. The Type of Ground Truth Used
The "ground truth" for this device would be the objective measurements obtained through standardized laboratory tests (e.g., mechanical properties, corrosion tests, cytotoxicity tests) as defined by ISO 9693 and other relevant material standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/SaMD device. There is no concept of a "training set" for a dental alloy in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided document (a 510(k) summary) does not detail a specific "study" with experimental results, but rather states the conclusion of testing conducted to demonstrate compliance.
The study that proves Duo Pal 6 meets acceptance criteria is inferred to be a series of laboratory tests and analyses performed on the material. These tests were conducted according to the methodologies prescribed by international standard ISO 9693 (for dental ceramic-to-metal bonding alloys) and other tests necessary to fulfill the essential requirements of the European directive 93/42/ECC concerning medical devices.
The specific results of these tests and the details of their methodology (e.g., number of specimens tested for each property) are not included in this summary but would have been part of the full 510(k) submission. The FDA's substantial equivalence determination (K012841) indicates that they reviewed this data and found it sufficient to support the claims of compliance and safety. The statement that "Duo Pal 6 is highly corrosion resistant and has an excellent biocompatibility" are outcomes of these implicit tests.
§ 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.