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The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.

The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone. The implants come in corresponding diameters of 3.7 and 4.3 mm.

The provided text describes the Z7 Zirconia Implant System, a dental implant device, and its compliance with FDA requirements for substantial equivalence to a predicate device. However, the information you've requested regarding acceptance criteria and study details in the context of an AI/ML device is not present in this document.

The document is a 510(k) clearance letter for a medical device manufactured from Zirconia (an endosseous dental implant), not an AI/ML-driven medical device. Therefore, it does not contain information about:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample size for test sets in an AI context
• Data provenance for AI training/testing
• Number/qualifications of AI ground truth experts
• Adjudication methods for AI ground truth
• MRMC studies for AI assistance
• Standalone AI algorithm performance
• Type of ground truth used for AI
• Training set sample size for AI
• Ground truth establishment for AI training

The performance testing summarized in the document (Page 7) is related to the physical and material properties of the dental implant itself:

• Material Performance Testing: Per ISO 13356:2015 for Yttria-stabilized tetragonal zirconia (Y-TZP).
• Fatigue Testing: Per ISO 14801:2016 for dynamic loading of endosseous dental implants.
• Implant Surface Roughness and Chemical Analysis Validation: Through 3D Scanning Electron Microscope (SEM) Imaging and Energy Dispersive Spectrometry (EDS Analysis).
• Biocompatibility: According to ISO 10993-1 and ISO 10993-5 (cytotoxicity).
• Endotoxin Testing: Following USP and USP.
• Sterilization Validation: Per ISO 11135:2014 (Ethylene Oxide) and ISO 17665 (Moist Heat) for sterility assurance level (SAL) of 10^-6.
• Shelf-Life Validation: Accelerated aging followed by real-time aging.

For these physical device tests, all results are reported as "PASS" and "Device met all predetermined acceptance criteria" or "Substantially equivalent fatigue strength to reference device."

To reiterate, this document does not contain the information you are looking for regarding AI/ML device acceptance criteria and study details.

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