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As an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

When splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.

For denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function when good primary stability is achieved and with appropriate occlusal loading.

A self-tapping CP Titanium or Titanium Alloy threaded screw, with light grit blasting or roughened surface treatment.

Device Acceptance Criteria and Performance Study Analysis

The provided document describes the 510(k) submission for the I-Mini Dental Implant. However, it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance data related to such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting performance data against defined acceptance criteria.

Therefore, I cannot provide the requested information for the following sections as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, if any, and its effect size
• Standalone (algorithm only) performance study, if any
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

Key takeaway from the document:

The I-Mini Dental Implant received 510(k) clearance based on its substantial equivalence to existing predicate devices (IMTEC Sendax MDI and BioHorizons Maestro System 3.0mm) in terms of design, function, labeling, material composition, and intended use, rather than on the basis of new performance data against specific acceptance criteria. This is a common pathway for medical device clearance when a new device is similar enough to previously approved devices.

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