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IR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR Implant System is intended only for straight placement with no correction of angulation.

IR Type Implant System is a dental implant system made of of CP Ti Gr. 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves a device meets those criteria. The document discusses regulatory approval for a dental implant system (IR Type Implant System) based on its substantial equivalence to a predicate device.

Specifically, it mentions:

• Acceptance Criteria/Performance Data: The document states that "The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device." However, it does not specify what those criteria were (e.g., specific thresholds for a given metric) nor does it provide the reported device performance against those criteria in a table format as requested. The tests mentioned are non-clinical (sterilization, surface characteristics, cytotoxicity, sensitization, LAL Endotoxin, shelf life), which are standard for medical devices but not directly related to a diagnostic performance study with a test set of data.
• Sample size and data provenance: Not applicable as no diagnostic performance study on a test set is described.
• Number of experts and qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth: Not applicable.
• Training set sample size and ground truth establishment: Not applicable.

The document's focus is on demonstrating substantial equivalence for regulatory clearance (510(k)), primarily through comparison with a predicate device and non-clinical engineering/materials testing, rather than a clinical performance study involving a test set of data and human readers in the context of AI or diagnostic performance.

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