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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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OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;

OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:

Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.

Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.

Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.

OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.

The ZircoSeal surface treatment is the trade name of zirconium nitride.

The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.

This document is a 510(k) premarket notification for the OsteoReady® ZircoSeal® Abutments, asserting substantial equivalence to previously marketed devices. It does not describe a study to prove a device meets specific acceptance criteria in the way one might expect for a diagnostic or AI-powered device.

Instead, the "acceptance criteria" here refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through performance testing, biocompatibility testing, and comparison of device characteristics.

Here's an analysis based on the provided text, addressing your questions where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" paired with "reported device performance" in the context of clinical accuracy or performance metrics for an AI/diagnostic device. Instead, it lists the types of tests conducted and their successful outcomes as proof of equivalence and safety.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or data provenance in the context of a clinical performance study (e.g., for AI/diagnostic algorithms). The "tests" mentioned are non-clinical, such as sterilization, biocompatibility, and material characterization. Therefore, information about "sample size for a test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a dental abutment, not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method

Not applicable. There is no clinical study involving human interpretation or ground truth adjudication in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention an MRMC study. The device is a physical dental abutment, not a diagnostic tool requiring human-AI comparative effectiveness evaluation.

6. Standalone Performance Study

Yes, in a non-clinical sense. The testing performed (sterilization, biocompatibility, surface treatment evaluation) assessed the standalone performance of the OsteoReady® ZircoSeal® Abutments against established standards (ISO, AAMI) and similarity to predicate devices. However, this is not a "standalone algorithm performance" study as would be relevant for an AI device.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. The "truth" in this context is established by:

• Standards compliance: E.g., ISO 10993-5 for biocompatibility, ISO 17665-1/2 and ANSI/AAMI ST79:2010 for sterilization.
• Material specifications: GR-5 Titanium Ti-6Al-4V ELI.
• Manufacturing specifications: Device design features (diameters, lengths, connection type).
• Chemical analysis: For surface treatment evaluation.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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