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Duranext Abutments are intended for use with dental implants as a support for single or multiple toth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Duranext Abutments from Elegant Direct Corp. are a line of machinable blanks incorporating interface features compatible with eleven (11) endosseous dental implant system platforms (three (3) designs from two (2) manufacturers) and intended to be milled at an Elegant Direct Corp. validated milling center to produce patient-specific dental implant abutments. The subject device platform diameters range from 3.0 mm to 6.0 mm, and the corresponding compatible implant body diameters range from 3.0 mm to 6.0 mm.

Duranext Abutments are designed for fabrication of custom titanium alloy dental implant abutments by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The portion of each abutment available for milling is 9.5 mm in diameter and 20 mm long. The apical end is premanufactured to fit the compatible implant platform, as shown above, and is available in an engaging (anti-rotation) design. A feature at the coronal end of the abutment is provided to interface with the milling equipment. Each abutment is provided with a screw designed to fit the compatible implant. The patient-specific abutment is intended to support a cement-retained single crown or multi-unit restoration.

The provided document is a 510(k) summary for the Duranext Abutments, a dental device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Therefore, I cannot extract the information required for questions about AI performance, multi-reader multi-case studies, or specific details of ground truth establishment for AI training/testing.

However, I can provide information about the acceptance criteria and the non-clinical study that proves the device meets those criteria, as well as general device information.

Here's what can be extracted based on the document:

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

The document does not explicitly present a table of "acceptance criteria" in the format of a diagnostic test (e.g., sensitivity, specificity). Instead, substantial equivalence is claimed based on performance testing and comparison to predicate devices for mechanical properties, biocompatibility, and sterilization. The acceptance criteria are implicitly met by successful completion of these tests in accordance with relevant ISO standards.

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

The document does not mention "test sets" in the context of diagnostic data. The "testing" refers to non-clinical performance testing of the physical abutment blanks. The sample sizes for these specific engineering tests (e.g., number of abutments tested for fatigue) are not provided in this summary. The provenance is implied to be from the manufacturer's testing or a contracted lab.

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, as this is a physical medical device (dental abutment) and the evaluation is based on non-clinical performance testing against engineering standards, not diagnostic interpretation by experts.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, which is not what this document describes.

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 abutment, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for this device's performance is established by engineering standards and physical measurements. For example:

• Biocompatibility: Established by adherence to ISO 10993 series standards, which involves methods like cytotoxicity testing.
• Mechanical Strength: Established by dynamic fatigue testing according to ISO 14801, which defines acceptable load cycles and failure modes.
• Dimensional Compatibility: Established by reverse engineering and direct measurement against OEM specifications.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no training set in the context of machine learning.

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

Not applicable. As above, there is no training set. The "ground truth" for the device's design and manufacturing parameters is established via engineering specifications, material properties, and adherence to relevant ISO standards, rather than a labeled dataset.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with:

• · NobelActive: NP Ø3.5; RP Ø4.3 / Ø5.0; WP Ø5.5
• NobelParallel CC: NP Ø3.75: RP Ø4.3 / Ø5.0: WP Ø5.5
• NobelReplace: NP Ø3.5; RP Ø4.0 / Ø4.3 / Ø5.0; WP Ø5.0; 6 Ø6.0
• NobelSpeedy: RP Ø4.0 / Ø5.0; WP Ø5.0 / Ø6.0
• Brånemark: NP Ø3.3; RP Ø3.75 / Ø4.0; WP Ø5.0

The Panthera Dental Milled Bar is a metallic dental restorative device that is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• . Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the patient's impression; the dental professional prepares the model cast beforehand. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing (CAD/CAM) software system. The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement. The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

Here's a breakdown of the acceptance criteria and the study information for the Panthera Dental Milled Bars, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present acceptance criteria in a tabular format with specific numerical targets. Instead, it describes performance through compliance with recognized standards and successful testing outcomes. The "performance" is primarily demonstrated through meeting mechanical strength requirements and biocompatibility standards, and by showing substantial equivalence to a predicate device.

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

• Sample Size for Test Set: The document does not specify the exact sample size for each test (e.g., how many bars were subjected to fatigue testing). It refers to "the bar itself" and "the bar cylinders" for fatigue testing. For reverse engineering, it mentions "each interface connection" and "each components per size and type" which implies multiple samples were analyzed to determine critical parameters and tolerance limits.
• Data Provenance: The document does not specify country of origin for data. The non-clinical testing was conducted by Panthera Dental Inc., a Canadian company. The tests are framed within the context of a 510(k) submission to the U.S. FDA. The testing conducted was for the primary predicate device (K173466) and determined to be applicable to the proposed device due to identical materials and manufacturing processes. The tests were retrospective in the sense that they were done on manufactured devices/components.

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

• Number of Experts: This information is not explicitly stated. The document refers to compliance with ISO and FDA guidance documents for testing, which implies a standard methodology rather than expert consensus on a subjective test set.
• Qualifications of Experts: Not specified. Testing was performed by Panthera Dental Inc. or their designated testing facilities to meet recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned (fatigue, biocompatibility, sterilization, reverse engineering, process capability) are objective physical, chemical, and mechanical tests, not subjective evaluations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Panthera Dental Milled Bars are a physical dental device, not an AI or imaging diagnostic tool that would typically involve a reader study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or software. The mention of CAD/CAM refers to the design and manufacturing process, not an independent algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Compliance with recognized standards: ISO 14801 for fatigue testing, ISO 10993 series and USP for biocompatibility, and ANSI/AAMI-ST8 for sterilization.
• Measurement and verification: Reverse engineering to ensure precise fit with implant systems.
• Predicate device equivalence: Performance data for the predicate device (K173466) is directly applied due to identical materials, design principles, and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. The design and manufacturing processes are established based on engineering principles and validated through testing.

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

Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing parameters are established through engineering design, material science, and testing against industry standards, not via a machine learning training process.

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The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
• Abutment Screws to permanently fix the abutments to the Implant.
  Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
  Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
  Core 3D abutments and are compatible for use with the following dental implants:
• Nobel Biocare Branemark System (K022562, K934825)
• Zimmer Tapered Screwvent (K013227, K061410, K072589)

The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
• Abutment Screws: to fix abutments to the underlying dental implant.
  The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system:
• CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
• Scanner: 3Shape D810 model
• Milling machine: SAUER HSC-20 DMG.
  Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
  The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:

Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
• Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.

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

• Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
• Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.

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