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Porta Geo Ti 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 - t Telescopic and milling work Porta Geo Ti can be veneered with suitable dental ceramics as well as with dental-composites. In addition Porta Geo Ti in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of Porta Geo Ti are joined to form dental restorations.

Porta Geo Ti is an extra-hard qold-platinum ceramic alloy with high contents of noble metals (95.4%), 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 as well as for laser welding. For this application it will be delivered in the shape of laser welding wires. Porta Geo Ti 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 Geo Ti 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.

The provided text describes a 510(k) premarket notification for a dental alloy named Porta Geo Ti. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Argedent 77PF K 935507) rather than reporting on a study that establishes acceptance criteria through performance data.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, ground truth, training set), is not available in the provided text.

The document states that Porta Geo Ti "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 provide the specific acceptance criteria within these standards, nor does it detail the study (or studies) conducted to "prove" that the device meets them with specific performance metrics. The 510(k) summary is highly focused on a descriptive comparison to the predicate device and asserting compliance with general standards.

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Porta Geo Ti is a gold-platinum ceramic 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 Geo Ti can be veneered with suitable dental ceramics as well as with dentalcomposites.

Porta Geo Ti is an extra-hard gold-platinum ceramic alloy with a high content of noble metals (95,4%), 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 removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Geo Ti 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 Geo Ti 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.

The provided text describes a 510(k) premarket notification for a dental alloy named "Porta Geo Ti". It focuses on the device description, its intended use, and its equivalence to a predicate device. However, it does not contain any information about a study proving device performance against acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document refers to compliance with ISO 9693 and the European directive 93/42/ECC, which implies that certain performance criteria are met, but it does not detail a specific study or present performance data.

Here's what I can extract from the provided text about the device:

Device Description and Claims (Not Acceptance Criteria or Performance Data):

• Device Name: Porta Geo Ti
• Device Type: Extra-hard gold-platinum ceramic alloy
• Intended Use: For dental technicians to fabricate dental restorations.
• Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
• Composition: High content of noble metals (95.4%), free of copper.
• Properties Claimed: Highly corrosion resistant, excellent biocompatibility.
• Compliance: Fully complies with international standard ISO 9693 and fulfills essential requirements of European directive 93/42/ECC.
• Aesthetic Benefit: Golden yellow color provides an excellent basis for aesthetically pleasing dental restorations when veneered with suitable dental ceramics or composites.

Missing Information:

The provided text does not include:

• A table of acceptance criteria.
• Reported device performance data.
• Details of any study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Argedent 77PF, K935507) based on device characteristics, indications for use, and compliance with general standards, rather than presenting a detailed performance study against specific acceptance criteria.

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