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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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The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.

The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.

However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.

Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.

Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.

Here's how to address each point based on the provided text:

Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)

Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.

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

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The ATLANTIS® Conus Structure is indicated for attachment to ATLANTIS® Conus abutment, Overdenture (OD) via prefabricated SynCone 5° Taper caps (Degulor®) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The ATLANTIS® Conus Structure is intended for conical attachment to a minimum of four (4) ATLANTIS® Conus abutments, Overdenture (OD). The ATLANTIS® Conus Structure is only intended for acrylic or composite veneering.

The proposed ATLANTIS® Conus structure is a patient-specific endosseous dental implant support structure that is indicated for attachment to dental abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS® Conus Structure is fabricated using additive manufacturing to produce a customized, patient-specific device.

The proposed ATLANTIS® Conus Structure is available in the following design types:

1. ATLANTIS® Conus Bridge Intended for direct veneering using dental resin composites resulting in a removable friction-retained prosthesis. The bridge provides a full anatomical base for composite layering techniques.
2. ATLANTIS® Conus Hybrid Intended as a removable friction-retained denture framework. The hybrid variant provides a surface with retention elements that can be finished with resin-based denture prosthesis.
3. ATLANTIS® Conus Base Intended as a removable friction-retained denture framework for finishing with the resin-based denture prosthesis.

The provided text describes the ATLANTIS® Conus Structure, a dental device, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human readers or ground truth established by experts.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and technological characteristics comparison. It does not contain information about a clinical study with acceptance criteria for diagnostic performance, human reader improvement, or ground truth established by experts.

However, I can extract the acceptance criteria and performance data for the non-clinical performance tests described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the non-clinical performance tests (dynamic fatigue, bond strength, dimensional verification). The data provenance is internal testing performed by Dentsply Sirona. These are prospective tests designed to evaluate the physical properties of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" here pertains to engineering specifications and performance standards outlined in ISO 14801 and internal Dentsply Sirona testing protocols.

4. Adjudication method for the test set

Not applicable. The tests are mechanical and dimensional, not requiring expert adjudication of results. The results are typically compared against pre-defined engineering specifications.

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 a physical dental implant component, not an AI-assisted diagnostic device.

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

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

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" refers to established engineering standards (e.g., ISO 14801) and internal design specifications for mechanical strength, bond strength, and dimensional accuracy.

8. The sample size for the training set

Not applicable. The device is a physical product, not an AI model requiring a training set. The design and manufacturing processes are iterative but do not involve "training data" in the AI sense.

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

Not applicable, as there is no "training set" for this physical device. The design and manufacturing parameters are established through engineering principles, material science, and prior regulatory clearances of similar devices.

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