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JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.

Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations

JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.

In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.

JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.

The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.

Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.

The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.

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JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon.

Abutment and accessories are exclusive for JDentalCare® implant system JDIcon®

JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered.

Their surface is treated through sandblasting followed by acid etching treatment.

JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.

This FDA 510(k) summary describes the JDentalCare® Implant System JDIcon® and demonstrates its substantial equivalence to previously marketed predicate devices, rather than presenting a study proving performance against specific acceptance criteria.

The document focuses on comparing the proposed device's characteristics and performance to legally marketed predicate devices. It doesn't define absolute "acceptance criteria" in the sense of predefined thresholds for a new study, but rather demonstrates that the new device meets the established safety and effectiveness profile by being similar to already cleared implants.

Therefore, the requested tables and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not directly applicable or provided in this type of regulatory submission.

However, I can extract information related to how the device's performance was evaluated and how it compares to existing standards and predicate devices, which implicitly serve as "acceptance criteria" for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Implied by Comparison to Predicates):

Regarding the specific numbered questions:

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

   • This has been provided above, interpreting the comparison to predicate devices and standards as the implicit "acceptance criteria" for substantial equivalence.

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

   • This document is a 510(k) summary, which inherently relies on demonstrating substantial equivalence to already legally marketed devices. It describes engineering tests and biocompatibility assessments, rather than clinical trial data with patient samples.
   • Sample Size: Not specified in the document for any particular test. These are typically bench tests following standardized methodologies.
   • Data Provenance: Not explicitly stated as "country of origin for data." The tests are performed "according to ISO" or "in compliance with FDA guidance," implying standard laboratory or testing facility setups. There is no mention of human subject data, therefore, no retrospective or prospective study is described in this context for performance evaluation.

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 document does not describe a clinical study where ground truth is established by experts (e.g., for diagnostic accuracy). The "ground truth" here is compliance with engineering standards and demonstration of similar functional characteristics and safety profiles to existing devices.

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

   • Not applicable. As above, this document does not describe a clinical study requiring adjudication of expert interpretations.

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 device is a dental implant system (a physical medical device), not an AI algorithm for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

   • Not applicable. This device is a physical dental implant system, not a software algorithm.

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

   • The "ground truth" in this context is established by:
     • Standardized Test Methods: Adherence to international standards like ISO 14801 (mechanical fatigue), ISO 10993 (biocompatibility), ISO 11137 (sterilization), and ASTM F67/F136 (materials).
     • Comparison to Legally Marketed Predicate Devices: The key "ground truth" for a 510(k) is that the device is substantially equivalent in safety and effectiveness to a device already cleared by the FDA. This relies on the established safety and effectiveness of the predicate.
     • Internal Validation: Surface validation and cleaning process validation are internally conducted and documented.

8. The sample size for the training set

   • Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set for a physical dental implant.

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