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Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

• · Two stage: MPI, ULT, API and CPI models
• One stage: OPI model

The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

Two stage and One stage implants for temporary or long-term use: MPI, ULT, API, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI and OPI designs are indicated for immediate loading (except for MPI and API in 6mm length) when good primary stability is achieved and with appropriate occlusal loading.

MPI, ULT, API, CPI and OPI are indicated for immediate loading (except for MPI and API in 6mm length) in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.

The 30-degree multi-unit abutments shall be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments shall be used within 32 degrees of parallelism for a splinted restoration.

This submission covers the changes related to Ditron's dental implants and abutments. The addition of more products' variations is to offer dental surgeons additional implant options for patient treatment.

The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:

. Modification to the MPI Model -
The MPI features an expanding tapered implant body with double-thread selftapping design to gradually condense the bone.

The MPI model remained the same as cleared under K140727 except for the following modifications:

Length: 6mm (only with diameter of 4.2mm, 5.0mm and 6.0mm), Diameters: 3.3 (with lengths 8.0mm, 10mm, 11.5mm, 13mm and 16mm). The 'groove' between thread leads which is part of the MPI design in all dimension variations, was removed only at the OD 3.3mm design.

All MPI dimensions are detailed in section 7 of this 510(k) summary.

An additional implant type: ULT (Ultimate) -.
The ULT design is based on Ditron's cleared MPI model. The ULT features an expanding tapered implant body and a truncated-cone profile provides root-form morphology of the tooth root.

The implant has a self-tapping design and micro threads at the top of the implant. All ULT implant dimensions are detailed in section 7 of this 510(k) summary.

• An additional implant type: API (Advanced Precision Implants) -●
  The API design is based on Ditron's cleared MPI model. The API features an expanding tapered implant body with double-thread self-tapping implant body and apex design. The design is intended for subcrestal placement.

The implant beveled collar shifts the implant-abutment junction inward, in order to achieve platform-switching configuration. Only the 6mm API model includes a 'groove' while the others do not. All API implant dimensions are detailed in section 7 of this 510(k) summary.

● An additional Abutment type: Milled Abutment -
The Milled Abutment design is based on Ditron's cleared Straight Abutments. The Milled Abutment allows the dentist to produce customized abutments (no additional angular correction).

No CAD/CAM design and fabrication is allowed for the Milled Abutment models. Only hand-milling or casting may be used for abutment modification.

● An additional Abutment type: Liberator Abutment -
The Liberator Abutment is an overdenture retention abutment. Its design is based on Ditron's cleared Ball Attachments. The Liberator abutments are used for tissue and implant support of overdentures. Typically with two or more relatively parallel implants. Liberator overdenture retention abutments provide firm retention and stabilization to the overdenture.

The Liberator Abutment is available is several length dimensions of 0.5, 1.0, 2.0, 3.0, 4.0 and 5.0mm.

● Straight Multi-Unit Abutment -
Additional two lengths were added to Ditron's cleared Straight Multi-Unit abutments. These length dimensions are: 4.0mm and 5.0mm. All dimensions' variations of the straight Multi-Unit abutments are detailed in section 7 of this 510(k) summary.

All above described implants and abutments are made of biocompatible 6A1-4V-ELI Titanium grade.

The provided document is a 510(k) summary for Ditron's Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study for a novel device. As such, it primarily details non-clinical performance data and uses comparison to established predicate devices as its "proof".

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported numerical performance values in the way one might expect for a diagnostic AI device. Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of specific tests, and "performance" is stated as meeting these requirements.

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

The document describes non-clinical performance data for dental implants and abutments. Therefore, the concept of "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical studies with human participants does not apply directly. The "samples" used were the physical dental implant and abutment devices and their components which underwent various engineering and laboratory tests.

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 to the provided document. The "ground truth" for non-clinical engineering tests (like fatigue, sterilization, biocompatibility) is defined by established international standards (e.g., ISO, AAMI) and regulatory guidance documents (e.g., FDA Guidance). The experts involved would be engineers, material scientists, and microbiologists conducting the tests and interpreting results against these standards, rather than medical experts establishing a "ground truth" for patient data.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of medical images or patient outcomes. The non-clinical tests described here are objective laboratory measurements against defined 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

This question is not applicable. The document concerns dental implants and abutments, which are physical medical devices, not AI-powered diagnostic tools. Therefore, an MRMC study related to AI assistance for human readers does not apply.

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

This question is not applicable, as the device is a physical dental implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on international standards and regulatory guidance documents (e.g., ISO 14801 for fatigue, ISO 11137-2 for gamma sterilization, ISO 10993-1 for biocompatibility). These standards define acceptable limits and methodologies for demonstrating the safety and effectiveness of medical devices.

8. The Sample Size for the Training Set

This question is not applicable. The document describes pre-market notification (510(k)) for physical medical devices and their non-clinical testing, not an AI or machine learning model that requires a training set.

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

This question is not applicable, as there is no "training set" in the context of this 510(k) submission for dental implants and abutments.

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The Ditron Dental Implant and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

• Two stage: MPI, CPI
• · One stage: OPI

One stage and One piece OPI 3.3 and 3.0 mm diameter implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

Two stage and One stage implants for temporary or long-term use: MPI, CPI, OPI are self-tapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites. MPI, CPI and OPI designs are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

MPI, CPI and OPI are indicated for immediate loading in single tooth restorations when good primary stability is achieved with appropriate occlusal loading.

The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

The Ditron Dental Implants and Abutments consist of one and two stage endosseous form dental implants, internal hexagonal implants and external hexagonal abutments, one piece implants system, cover screws and healing caps; abutment systems and superstructures and surgical instruments.

The Molecular Precision Implant (MPI) features an expanding tapered implant body. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm. 13 mm and 16 mm with diameters of 3.5mm, 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.

The Cylindrical Precision Implant (CPI) is a cylindrical implant. It is available in lengths of 8.0 mm, 10 mm, 11.5 mm, 13 mm and 16 mm with diameters of 3.75 mm, 4.2 mm, 5.0 mm and 6.0 mm, except for the 16 mm length which is not available with a diameter of 6.0 mm.

The One Piece Implant (OPI) is a one piece implant with an integral abutment designed for one stage procedure and cemented restorations. It is available in lengths of 8, 10, 11.5, 13 and 16 mm with diameters of 3.0 and 3.3 mm Straight Abutments can be used with two platforms; normal and slim. The straight abutments are available at the following lengths of 11.5 and 8.5 mm with a diameter of 4.5 mm, length of 8.5 mm and 6 mm with a diameter of 3.8 mm, length of 2 and 4 mm with a diameter of 5.6 mm.

The Anatomic Angulated Abutment has an anatomic configuration with ascending and descending shoulders the height of the neck varies between 1, 2 and 3mm and is available in 2 different lengths; 1 and 3 mm. These abutments are available with angles of 15° and 25°.

Angulated Abutments are suitable for multi-unit implant restorations and are available with angles of 15° and 25° with lengths of 8.5 mm and 11.5 mm. Ball Retained Abutments feature a titanium ball for overdenture restoration and are available in the following dimensions: 0.5, 2, 3, 4, 5 and 6 mm. Less than 4mm post-height are suitable only for multi-unit loaded restorations.

Temporary Abutments require no cement and are supplied at lengths of 1, 2, 3, 5 and 7 mm.

Bar Retained Abutments less than 4mm post-height are suitable only for multiunit loaded restorations and are supplied in the following dimensions: 0.5, 1.5, 2.5 mm.

Multi-Unit Bar Retained Abutments provides support and retention for mutiunit screw-retained restorations and are available in two heights: 0.5mm and 1mm, and; two angles: 17° and 30° for each height for multi-unit loaded restorations.

Screw Retained Abutment is a supporting structure used to support lateral or horizontal pressure as an anchorage for single tooth or more (bridge). The package is supplied with the abutment and the matching screw. Less than 4mm post-height are suitable only for multi-unit loaded restorations or for single-unit loaded restorations if used in combination with plastic sleeve per Ditron labeling. Cover screw is made of titanium and supplied sterile with the implant.

All implants and body contact abutments are made of biocompatible Titanium 6A1-4V-ELI.

The provided text is a 510(k) premarket notification for Dental Implants and Abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices and includes information about the device's design, materials, and intended use. However, it does not contain specific acceptance criteria, reported device performance data, details of a study proving meeting acceptance criteria, or information regarding sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details. The document states that "A series of safety and performance tests and evaluations were performed to demonstrate that Ditron's Dental Implant System does not raise any new issues of safety and effectiveness. These evaluations include fatigue, surface analysis, biocompatibility, sterilization validation and shelf life validation in order to assure maintaining of SAL 10to along the shelf life." However, it does not provide the specific numerical acceptance criteria or the results of these tests.

The document's purpose is to establish substantial equivalence for a physical medical device, not to present performance data for an AI/ML system.

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