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The Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for 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.

Spiral Shape Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16 (no 6.0 diameter in 16). Both straight and angled abutments are available.

The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

The provided text describes a medical device submission (K162299) for the "Spiral Shape Dental Implant System". It details the device's indications for use, its description, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of image analysis, AI, or diagnostic efficacy.

The testing summarized (Dynamic fatigue testing, Surface analysis, Sterilization validation, Package integrity testing, Biocompatibility, Endotoxin testing) are standard engineering and material science tests for dental implants, not performance studies for a diagnostic or AI-driven device.

Therefore, I cannot provide answers to the questions you've posed, as they relate to a type of study and data (e.g., AI performance, expert ground truth, MRMC studies) that are not present in the provided FDA submission document for a dental implant system.

The document primarily focuses on demonstrating that the new dental implant system is substantially equivalent to existing legally marketed predicate devices based on:

1. Indications for Use: (described as: "The Spiral Shape Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for 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.")
2. Materials: Ti-6AL-4V ELI.
3. Design: Conical shape, grit blasted and acid etched surface, internal hex connection, various diameters and lengths.
4. Fatigue Performance: Tested according to ISO 14801.

The provided text describes a 510(k) submission for a dental implant system, not a device involving image analysis, AI, or diagnostic performance evaluation with acceptance criteria like sensitivity, specificity, or AUC. Therefore, the requested information elements related to AI/algorithm performance, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this document.

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