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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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JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system 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 is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form 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 machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.

However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.

2. Sample Size for Test Set and Data Provenance

This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.

• Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
• Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.

4. Adjudication Method

Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.

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

Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device, which refers to its performance and safety, is established through:

• Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
• Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
• Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
• Comparison to predicate devices with an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.

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

Not applicable.

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