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The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

The I Macro 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.

The provided document is a 510(k) summary for a dental implant (I Macro 6.0mm X 6.0mm) and focuses on establishing substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria, device performance metrics, or details of a specific study to prove the device meets such criteria in the way typically expected for an AI/ML medical device.

The study referenced in the document is a non-clinical testing data used to demonstrate substantial equivalence to predicate devices, rather than proving a novel device meets specific performance acceptance criteria for diagnostic or clinical tasks.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size with AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a regulatory submission for a physical medical device (dental implant), not an AI/ML software device, and thus the type of information requested (e.g., test sets, ground truth, expert adjudication, AI performance metrics) is not applicable or present.

The document states:
"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, pull-out testing, and static and dynamic compression-bending testing according to ISO 14801."

This indicates that the "study" conducted was a series of engineering and biomechanical tests to ensure the physical properties of the new implant were comparable to existing ones, which is standard for substantial equivalence for physical devices. It does not involve "performance" in the context of diagnostic accuracy, sensitivity, specificity, etc., which would require a clinical dataset and ground truth.

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