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MSDI Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support or prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

MSDI Dental Implants System implants are self-tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function.

The MSDI's dental implant is a two stage screw type device that can equally well be used as one stage, surgically placed in the upper or lower jaw to provide support for prosthetic devices in partially or completely edentulous patients. The MSDI's implant is a two piece device to be used in combination with several different abutments and superstructures provided in order to aid in the prosthetic rehabilitation.

MSDI dental implants System is an internal hex implant system which provided in 3.3, 3.75, 4.2, 5.0 and 6.0 mm diameter for lengths of 8, 10, 11.5, 13 and 16mm. (There is no 6.0 mm diameter for the 16 mm length).

The MSDI Dental Implants are to be used in combination with cover screws, healing caps and abutments according to commonly used protocol in the dental implantation field.

The MSDI Dental Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The implants are grit blasted and acid etched surface. The system includes standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi- unit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

The provided document is a 510(k) Premarket Notification for a dental implant system, not an AI/software device. Therefore, the information typically required for describing the acceptance criteria and study proving device meets acceptance criteria for an AI/software device, such as those related to AI performance metrics (sensitivity, specificity, AUROC), expert reader studies, ground truth establishment, training/test set details, and MRMC studies, is not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the "MSDI Dental Implants System" to legally marketed predicate devices. This involves comparing:

• Intended Use/Indications for Use: The devices serve the same purpose.
• Technological Characteristics: Material, design (screw type, internal hex), surface treatment, dimensions, and accessories (abutments, healing caps) are compared.
• Performance Testing: Non-clinical tests like dynamic fatigue testing (ISO 14801), sterilization validation (ISO 11137-1/2, ISO 17665-1/2), biocompatibility (ISO 10993-5), endotoxin testing (USP 161), and cleanliness (ISO 19227) are mentioned to show the device performs comparably and safely.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study data from this document. The document explicitly states: "No clinical performance data is provided in this submission," further indicating the absence of human-in-the-loop or standalone performance studies in a clinical context that would yield the types of performance data you're asking for.

If you have a document related to an AI/software medical device, please provide that, and I will be able to answer your questions.

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