(52 days)
Simidur S1S is a palladium-base 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. Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.
Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single 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. Simidur S1S 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. Simidur S1S can be veneered with suitable dental ceramics and with dental composites.
The provided text describes a submission for a dental alloy, Simidur S1S, to the FDA for 510(k) premarket notification. The document states that the device "fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not contain the detailed methodology and results of a study as typically required to demonstrate that a medical device meets specific acceptance criteria in the manner requested. Specifically, it lacks information regarding clinical studies, performance metrics, sample sizes, ground truth establishment, or expert involvement in a medical device testing context.
Thus, I cannot provide the requested table or describe a study in the detailed format requested based on the given information. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device (Argelite 58P, K891320), rather than on a new clinical performance study.
Here's what can be extracted, aligning with the spirit of the request but acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Properties | Compliance with ISO 9693 for dental alloys. | Simidur S1S "fully complies to the international standard ISO 9693". |
| Biocompatibility | Excellent biocompatibility. | Simidur S1S has "excellent biocompatibility". |
| Corrosion Resistance | High corrosion resistance. | Simidur S1S is "highly corrosion resistant". |
| Material Composition | Palladium-base ceramic alloy (56.0% Palladium), copper-free. | Simidur S1S is a "palladium-base ceramic alloy (56,0% Palladium)" and is "free of copper". |
| Veneering Capability | Suitable for veneering with dental ceramics and composites. | Simidur S1S "can be veneered with suitable dental ceramics and with dental composites." |
| Indications for Use | Fabrication of dental restorations including crowns, short span bridges, long span bridges, removable partials, and for telescopic and milling work. | Simidur S1S has an "indication which ranges from single 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." |
| Regulatory Compliance | Fulfillment of European directive 93/42/ECC concerning medical devices. | Simidur S1S "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The submission relies on "substantial equivalence" to a predicate device and compliance with standards, rather than a clinical trial with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document does not describe a clinical study or expert-adjudicated test set.
4. Adjudication method for the test set:
- This information is not provided. No adjudication method is mentioned as there isn't a described test set requiring one.
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:
- No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices, which is not what Simidur S1S is.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not conducted or described. This device is a physical dental alloy, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by compliance with international standards (ISO 9693) and European directives (93/42/ECC), as well as by demonstration of substantial equivalence to an already marketed device (Argelite 58P). The document does not specify a clinical "ground truth" derived from patient outcomes or pathology in the context of a new study for this submission.
8. The sample size for the training set:
- This information is not applicable as Simidur S1S is a material, not an AI model, and therefore does not have a "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.
In summary, the provided FDA 510(k) summary is for a dental material (alloy) and discusses its compliance with established material standards and equivalence to a predicate device, rather than presenting a performance study with detailed clinical acceptance criteria, test sets, or expert evaluations typically associated with diagnostic or AI-driven medical devices.
§ 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.