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Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.

All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.

The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments.

The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm.

The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm.

The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles.

Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration.

The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3.

The provided document describes the K213997 Kontact Dental Implant System. This premarket notification primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and literature review, rather than establishing performance criteria against specific clinical endpoints with a device that provides diagnostic information. Therefore, the typical structure for acceptance criteria and a study proving a device meets these criteria for an AI/ML diagnostic or prognostic device is not directly applicable.

However, I can extract the relevant information from the document to describe how the manufacturer demonstrated that their device met the safety and performance requirements for a dental implant system.

Here's the information organized based on your request, with adaptations for a non-diagnostic medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental implant system), "acceptance criteria" are generally derived from recognized standards for biocompatibility and mechanical performance, and "reported device performance" refers to the results of non-clinical testing against these standards, as well as a review of clinical outcomes from a published study on similar implants.

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

For the non-clinical tests:

• Biocompatibility: The specific sample sizes for cytotoxicity and endotoxin tests are not individually stated but are implied to be sufficient per the referenced ISO and ANSI/AAMI standards.
• Mechanical Performance (ISO 14801): The sample size refers to "worst-case constructs," implying a selection of implant and abutment combinations designed to represent the most challenging scenarios for mechanical failure. The exact number is not explicitly stated.
• Data Provenance: The mechanical performance and sterilization data are from non-clinical bench testing conducted by the manufacturer. The biocompatibility evaluation also involved internal routine monitoring data.

For the leveraged clinical performance:

• Sample Size: 326 implants were evaluated in a published multi-center retrospective study.
• Data Provenance: This was a retrospective study. The country of origin is not specified, but it was a "multi-center" study.

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

This information is not directly applicable as this submission is not for an AI/ML diagnostic device requiring expert-established ground truth for a test set. The "ground truth" for this dental implant system is primarily established by:

• Compliance with recognized international standards (ISO, ANSI/AAMI): These standards define acceptable material properties and mechanical performance.
• Observation of physical outcomes in non-clinical bench tests: Mechanical integrity, sterilization efficacy, and MRI compatibility are directly measured.
• Leveraged Clinical Literature: The multi-center retrospective study (not conducted by the submitter) provides clinical outcome data (bone level changes, survival rate) for similar implants. The experts involved in that study (e.g., dentists, surgeons, researchers) would have established the "ground truth" of patient outcomes, though no specific number or qualifications are provided in this submission for that study.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML diagnostic or prognostic device with human adjudication. The "adjudication" for this device involves applying the results of the non-clinical tests (e.g., pass/fail for mechanical loads, conformity to biocompatibility limits) against the requirements of the referenced standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a dental implant system, not a diagnostic imaging device with AI assistance for human readers.

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 system), not an algorithm.

7. The Type of Ground Truth Used

• Non-clinical Testing: The ground truth for mechanical performance, sterility, and MRI safety is established by direct measurement and observation against predefined criteria in recognized scientific and engineering standards (e.g., force limits, microbial kill rates, magnetic susceptibility properties).
• Biocompatibility: Established by adherence to ISO 10993 standards for various biological endpoints, alongside review of existing data.
• Clinical Outcomes Data (leveraged): For the indirect clinical performance evaluation, the ground truth was based on clinical outcomes (bone-level changes, implant survival rates) derived from a published multi-center retrospective study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing processes are informed by engineering principles, material science, and prior predicate device data, rather than machine learning on a "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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Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.

The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).

The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for any of the non-clinical tests.
• Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.

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

• Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. There was no test set for clinical performance requiring adjudication.

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. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.

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

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

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

• Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.

8. The Sample Size for the Training Set

• Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.

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

• Not applicable. There was no training set.

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