Search Results

The MS system (Provisional) is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

The MS system (Provisional) is a dental implant system made of titanium metal intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to seve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. It has a screw-formed one piece of fixture and abutment made of Titanium Alloy Ti-6AL-4V (ASTM F 136) ELI with diameter 1.8, 2.5mm and length 10, 13, 15mm It has machined surface, and is supplied sterile.

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) summary for a dental implant system (MS system Provisional) and primarily focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, contra-indications, and confirms that safety and performance validations were conducted.

However, it does not include:

• Specific acceptance criteria: There is no table or explicit listing of performance metrics and their target values.
• Reported device performance: While it states "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations," it does not provide the results of these tests or any quantitative performance data.
• Details about the study that proves the device meets acceptance criteria: There is no description of a clinical or technical study, its methodology, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance: These are not applicable as the device is a physical dental implant, not an AI or imaging diagnostic tool.
• Sample sizes for test or training sets, or how ground truth was established for these datasets.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about the study, sample sizes, experts, adjudication, or ground truth. The document confirms that "extensive safety, performance, and product validations" were done and "appropriate safeguards have been incorporated," but it does not elaborate on the specifics of these validations or present data.

Ask a specific question about this device