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OsteoReady® 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. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;

Dental Implants:

Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);

Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;

RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;

Dental Abutments:

Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.

The provided document is a 510(k) Premarket Notification summary for the OsteoReady® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/ML-driven medical device.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML performance are not present in this document.

The document details the device's technical specifications, materials, and intended use, and then compares them to predicate devices to argue for substantial equivalence. The "performance" mentioned in the document refers to non-clinical bench testing (e.g., sterilization, shelf life, fatigue, biocompatibility) rather than clinical performance metrics typically associated with AI/ML device validation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The document does not define explicit quantitative acceptance criteria for clinical performance that would typically be seen for an AI/ML device, nor does it report clinical performance metrics. Instead, the "performance" discussed relates to non-clinical bench testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided as the submission focuses on substantial equivalence based on material properties, design, and non-clinical bench testing, not clinical studies with test sets of patient data for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. Ground truth for an AI/ML device performance study would typically involve expert annotations or pathology reports, which are not relevant to this type of 510(k) submission for a dental implant system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as no clinical test set for performance evaluation of an AI/ML device was conducted or reported.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. This type of study is specifically relevant to AI/ML devices that assist human readers, which is not the nature of the OsteoReady® Dental Implant System.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. This refers to AI/ML algorithm performance, which is not applicable to a physical dental implant system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the conformity to established engineering and material standards through non-clinical testing (e.g., ISO, ASTM, USP standards). There is no "ground truth" derived from clinical patient data or expert consensus in the sense of an AI/ML device.

8. The sample size for the training set

This information is not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.

9. How the ground truth for the training set was established

This information is not provided as there is no training set mentioned or relevant to this type of device.

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