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The T3® Pro Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

The T3® Pro Implants may also utilize immediate loading for these indications. The T3® Pro Implants are 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.

The T3® Pro Implants with the new ZimVie Implant Packaging System. The material and design of the subject device is identical to the primary predicate device T3® Pro Implants cleared in K213672.

The ZimVie Implant Packaging System configuration, similarly to the primary predicate device, consists of a titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed in a heat-sealed outer tray, covered with a Tyvek® lid. The outer tray is placed inside a cardboard box, and gamma sterilized. The new ZimVie Packaging System has been standardized to align the packaging across all ZimVie implant families. The subject device in the new ZimVie Packaging System has a shelf-life of two (2) years.

The provided FDA 510(k) clearance letter and associated documentation for the "T3 Pro Implants- ZimVie Packaging System" (K251660) do not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.

Instead, this submission is for a medical device (endosseous dental implant) and its new packaging system. The "performance data" section explicitly states that no clinical data was included in the submission for the substantial equivalence determination. The focus of the provided document is to demonstrate equivalence to a previously cleared predicate device for the dental implant itself, with the primary change being the packaging system.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance related to an AI-assisted or standalone AI system, nor can I provide details on sample size, expert adjudication, MRMC studies, or ground truth establishment, as these concepts are not discussed or relevant to the provided documentation for this specific 510(k) clearance.

The information provided describes non-clinical performance data related to the physical device and its packaging:

• Sterilization validation: Gamma irradiation sterilization to a sterility assurance level of 10^-6 according to ISO 13004 and ISO 11137.
• Aging studies: Demonstrating a shelf life of two (2) years for the implants, with packaging sterile barrier testing per ASTM F1980.
• Packaging studies: Simulated distribution and environmental conditioning per ISTA 3A and ASTM D4169.
• Biological evaluation: Leveraged from the primary predicate device, demonstrating no increased risks regarding biocompatibility. The material is Commercially Pure Titanium conforming to ASTM F67.
• MR Safety testing: Conducted according to ASTM F2503-13 on the primary predicate device (identical to the subject device) for MR Conditional determination.
• Bacterial Endotoxin Testing: Routinely performed using LAL assay in accordance with ISO 11737-3.

The acceptance criteria for this submission would primarily revolve around demonstrating that the new packaging system maintains the sterility, integrity, and safety of the dental implant for its stated shelf life, and that the dental implant itself remains identical to the previously cleared predicate device in all other aspects (materials, design, intended use, operating principle).

In summary, your request pertains to an AI/Software as a Medical Device (SaMD) study, while the provided document describes the 510(k) clearance process for a physical dental implant device and its new packaging.

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The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.

TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.

Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.

Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).

However, I can extract the information that is available and explain why other requested details are missing.

Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):

This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.

Missing Information and Explanations:

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

   • Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.

2. 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/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.

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

   • Not applicable/None. No clinical test set to adjudicate.

4. 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 (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.

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

   • Not applicable. As above, this is a physical medical device, not an algorithm or AI.

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

   • The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.

7. The sample size for the training set:

   • Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.

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The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

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

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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

This question is not applicable. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

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

This question is not applicable as there is no human interpretation or diagnostic "test set" that would require 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

This question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

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

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

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

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

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

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

| Implant Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

• 1. Minimum wall thickness 0.5 mm
• 2. Minimum post height 4.0 mm (for single unit restorations)
• 3. Maximum gingival height 5.0 mm (min. GH of 0.5mm)
• 4. Maximum angulation 20°

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.

Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.

The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
   • Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
   • Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
   • Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
   • Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).

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

   • This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).

4. Adjudication Method for the Test Set:

   • Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.

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:

   • No MRMC study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
     • ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
     • ISO 17665-1 & ISO 17665-2: For sterilization validation.
     • ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
     • Engineering and dimensional analysis: Based on specifications of original manufacturers' components.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.

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

   • Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.

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The TSX Implants are designed for use in the maxilla or mandible for immediate loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.

The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

TSX Dental Implants are manufactured from biocompatible titanium alloy. TSX Dental Implants surface consists of a Contemporary Hybrid Surface Treatment (Dual Acid Etch + MTX™ Textured Surface). The implants are available in different platform diameters and feature an internal hex connection for mating with associated Zimmer Dental and Biomet 3i internal connection restorative components.

For specific product descriptions, please refer to individual product labels.

The provided text is a Premarket Notification (510(k)) for the Biomet 3i LLC TSX Implants. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about an AI/ML powered device, nor does it include data from a clinical study on device performance against acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The document explicitly states: "No clinical data were included in this submission." This means that the information needed to answer most of your detailed questions about device performance validation against specified criteria is not present in the provided text.

The closest relevant information is under "XI. Non-Clinical Testing," which describes mechanical testing (ISO 14801:2016), sterility validation, pyrogenicity testing, SEM/EDS imaging for surface assessment, and biocompatibility testing. These are non-clinical tests to show the device's physical and biological properties are equivalent to predicate devices, not performance against clinical acceptance criteria for an AI/ML algorithm.

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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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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Titanium Coping, Temporary Cap, abutment screws, the Smileloc Activator (or Smileloc Remover) (all cleared under K160786) and Smilekey (cleared under K180609). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable. The Rodo Abutment System eliminates the need for an access hole on the occlusal surface of a screw-retained restoration and also eliminates the possibility of prosthetic screw loosening. The Smilekey is an induction heating device for dental prosthesis removal of the Smileloc Sleeve in the Rodo Abutment System. The Smilekey was cleared as an accessory to the Abutment System in K180609, and there have been no changes to the Smilekey since this clearance.

The Rodo Abutment is provided in five series designs (100 F, 200 P, 300 S, 400 M, 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 300 S series is designed for limited occlusal space and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 3.0 mm to 6.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided text describes a 510(k) premarket notification for the Rodo Abutment System, focusing on adding compatibility with new implant lines. However, it does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

The Rodo Abutment System is a hardware dental device, not an AI/ML software device. The "performance data" section discusses non-clinical testing such as dimensional analysis, reverse engineering, and fatigue testing according to ISO 14801. It does not refer to AI/ML model performance metrics, ground truth establishment, or human reader studies.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or multi-reader multi-case studies, as the provided document pertains to the clearance of a mechanical dental device and not an AI/ML-driven diagnostic tool.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Any sample sizes used for a test set in the context of AI/ML performance.
• Data provenance for AI/ML data (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for an AI/ML model.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance of an AI/ML model.
• Type of ground truth used (pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for a training set in the context of AI/ML.
• How ground truth for a training set was established for an AI/ML model.

The document's "Performance Data" section solely refers to non-clinical bench testing for a mechanical device.

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