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JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.

JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.

The JJ Implant System comprises three lines of endosseous root-form dental implants: two lines with an internal hexagonal prosthetic interface (Genesis Normo), mating abutments, abutments, abutment screws, and other associated components; and a line of one-piece, small diameter dental implants (Mini) for retention of overdentures.

This looks like a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to non-clinical performance and comparisons to predicate devices, rather than clinical efficacy studies with specific performance metrics like sensitivity/specificity often seen with AI/CADe devices.

Based on the provided document, here's a breakdown of the information:

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a dental implant (a passive medical device), the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy). Instead, they relate to safety, performance against established standards, and equivalence to predicate devices. The device's "performance" is demonstrated through successful completion of these non-clinical tests and a comparison of its technological characteristics and indications for use with predicate devices.

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

This device clearance is based on non-clinical performance data and substantial equivalence to predicate devices, not on a clinical "test set" with patient data in the context of AI/CADe. Therefore, there's no mention of a clinical test set sample size or its provenance in this document. The "test sets" would refer to the samples used in the mechanical and biocompatibility testing (e.g., number of implants tested for fatigue, number of samples for bacterial endotoxin, etc.), but specific numbers are not provided in this summary.

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)

Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic performance.

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

Not applicable, as no clinical "test set" in the diagnostic sense was used or described.

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

Not applicable. This is not an AI/CADe device, and no MRMC comparative effectiveness study was done.

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

Not applicable. This is a physical medical device (dental implant), not an algorithm.

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

Not applicable. For this type of device, "ground truth" is established by adherence to recognized consensus standards for material properties, mechanical strength, biocompatibility, and sterilization, as well as a demonstration of equivalence to legally marketed devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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BBX1, BBX2, BBX1MO, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.

BBX1, BBX1MO, BBX1MC and BBX2 dental implants whose material composition of the implants is titanium alloy Grade 5 ELI (Titanium 6 AL 4V), conforming to ASTM F-136 (Stundard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Surface treatment features include air blasting with Biphasic Calcium Phosphate (CaPO4) and HA micro particles, followed by acid passivation and cleaning, conforming to ASTM F1088 Surface Treatment HA, ASTM F-86 (Passivation), and ASTM F1185-03 Trace Elements.

BBX1, BBX1MQ, BBX1MC and BBX2 dental implants are all provided with screw thread and helix shape inclined grooves. For dental implant series BBX1, BBX1MC, the shoulder or abutment is integrated, that is, not a separate part of the whole implant. They are one piece dental implants.

Dental implants series BBX2 consists of three parts, one straight abutment, one screw and the implant body.

BBX1, BBX2, BBX1MO and BBX1MC dental implants consist of a threaded area, a transgingival area, mini threads, an implant body area and a vertical abutment.

This document describes a 510(k) premarket notification for dental implants (BBX1, BBX2, BBX1MO, BBX1MC). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be typically seen for a novel device or software. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for new clinical outcomes. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various characteristics. The "performance" assessment is based on non-clinical testing to ensure fundamental safety and material requirements are met, and that the new device's characteristics do not raise new safety or effectiveness concerns compared to existing devices.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data or clinical cases described for evaluating new clinical performance metrics. The demonstration of substantial equivalence relies on non-clinical testing and comparison to existing predicate devices.
• Data Provenance: The data provided is primarily technical and regulatory documentation comparing the subject device to predicate devices and demonstrating compliance with various ASTM and ISO standards for materials, manufacturing, and biocompatibility. There is no mention of country of origin for clinical data or whether it is retrospective or prospective, as clinical trials were not part of this submission for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not applicable. As there is no clinical "test set" with clinical outcomes that require expert ground truth establishment, no experts were utilized for this purpose in the context of this regulatory submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical "test set" requiring adjudication of results is mentioned.

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:

• MRMC Study: No. This device is a dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant to this submission.
• Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Not applicable. This device is a physical medical device (dental implant), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by established international and national standards (e.g., ISO 10993-5 for biocompatibility, ASTM F-136 for material composition and properties). Compliance with these standards serves as the "ground truth" for the device's fundamental safety and material characteristics. No clinical outcomes data for a novel device/AI application is mentioned as ground truth.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of this 510(k) submission for dental implants. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable.

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