Search Results

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 chewing function of patients with fully or partially edentulous:

• Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models .
• . One stage: OPI and TPI models

The 3.3mm and 3.0mm diameter implants (OPI and TPI. MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

The Two stages and One stage implants are indicated for temporary or long-term use. They are selftapping 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, OPI, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI. and API 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and 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 Temporary Titanium and PEEK Abutments are indicated to be used on Ditron implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

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

. An additional implant types:

• MPC (Conical Connection Molecular Precision Implant) o
• O APC (Conical Connection Advanced Precision Implant)
• UPC (Conical Connection Ultimate Precision Implant) O
• CPC (Conical Connection Cylindrical Precision Implant) O

The Conical Connection (CC) implants include a conical connection platform (Morse taper). The intended use, materials, drilling protocol, thread designs and bone interface of the subject Conical Connection implants (MPC, UPC, APC and CPC) are identical to Ditron's cleared Internal Hex connection platform implants (MPI, ULT, API and CPI, respectively). The CC implants include color anodization for aesthetic purposes. The CC compatible Cover and Prosthetic Screws are color anodized as well.

The MPC/APC/CPC/UPC Implants are available in diameters of 3.5mm, 4.2mm, 5.0mm, and 6.0mm, with lengths of 8.0mm, 11.5mm, 12mm, 13mm, 14mm, and 16mm. Additionally, a 6.5mm length is offered for MPC/APC/CPC implants in 4.2mm, 5.0mm, and 6.0mm diameters, and a 7.0mm length is available for UPC implants in 4.2mm, 5.0mm, and 6.0mm diameters.

• An additional Abutment type: CC Healing Caps and SRA Healing Caps Abutments The CC Healing Caps are color-anodized for aesthetic purposes. They are used for the maintenance of the soft tissue during the osseointegration phase of Ditron CC implants to be rehabilitated using technique. They are available in diameters of 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5 and 4.5mm.
• An additional Abutment type: CC Cement Retained Abutments the CC Anatomic/Universal . straight/angulated abutments are Cement-Retained Abutments. They are intermediary prosthetic components to be installed onto Ditron's CC implants to support the final prosthesis. They are available as straight (0°) or angulated (15° and 25°) in diameters: 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5 mm.
• . An additional Abutment type: CC Single-Unit and Multi-Unit Abutments - The CC Screw-retained Single Unit Abutment and Multi Unit Abutments are intermediary prosthetic components to be installed onto CC Ditron's implants to support the final prosthesis. They are available as straight (0°) or angulated (17° and 30°) and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.0 mm. The Single Unit abutment height is up to 4.5mm only.
• An additional Abutment type: CC Temporary Titanium Abutments The CC Temporary Titanium Abutments are temporary intermediary prosthetic components to be installed onto the Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are available as straight (0°) in diameters: 3.5 and 4.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5mm.
• An additional Abutment type: CC Temporary PEEK Abutments The CC Temporary PEEK Abutments are temporary intermediary prosthetic components to be installed onto Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium. They are available in diameters of 4.5 and 6.0mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5mm.
• An additional Abutment type: CC Liberator Overdenture Abutment The CC Liberator Overdenture Abutment is similar in design to Ditron's cleared Liberator abutment, except for the addition of Titanium Nitride (TiN) coating on the subject device. It is available in the following gingival heights: 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0mm.
• An additional Abutment type: SRA Titanium Coping Abutments The SRA Titanium Coping . Abutment is suitable for use with the CC Screw-retained single Abutments. It connects to the abutment using one of the designated abutment screws. They are available in short (L4.85mm) and long (L11mm) versions.
• Modification to Cleared Titanium Abutments Addition of Laser Marking for identification as an option for all of the Ditron Dental cleared Titanium Abutments (K140728, K161497, K233231).
• Modification to Cleared Liberator and TPI Overdenture Abutments Addition of TiN coating to . Ditron's cleared Liberator abutment (K161497) and the cleared TPI Liberator Overdenture Abutment (K233231).

The provided text does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a 510(k) summary for Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. It does not mention any AI/ML components or related studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results (effect size).
6. Standalone performance study for an algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

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 and TPI models
  The 3.3 and 3.0mm diameter models for One stage OPI and TPI, 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 and TPI are self-tapping Titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and longterm fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

MPI, ULT, API, CPI, OPI and TPI designs are indicated for immediate loading (except for MPI and API in 6.0mm length) when good primary stability is achieved and with appropriate occlusal loading.

MPI, ULT, API, CPI, OPI and TPI are indicated for immediate loading (except for MPI and API in 6.0mm length) 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.

This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

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

. An additional implant type: TPI (Tissue Level (One Piece) Precision Implant) -The TPI design is based on Ditron's cleared MPI Implant model and the 3.0mm Straight Multi-Unit Abutment, creating a one-piece implant. The TPI's implant part is identical to the cleared MPI Implant model, and the 3.0mm MPI Straight Multi-unit part has minor dimensional modifications and color anodization for aesthetic purposes. The TPI compatible Cover and Prosthetic Screws are color anodized as well.

An additional Abutment type: TPI Healing Caps Abutment -● The TPI Healing Caps design is based on Ditron's cleared Cylindered Healing Caps. The TPI Healing Caps are color-anodized for aesthetic purposes. The TPI Healing Caps Abutments are available in several Gingival height dimensions of 3.5, 4.5 and 5.5mm.

• . Modification to Cleared Titanium Abutments – Addition of color anodization as an option for all of the Ditron Dental System Titanium Alloy Grade 23 (Ti 6Al-4V ELI) Abutments cleared under K140727 and K161497, to enhance the aesthetic outcome of the dental prosthetics.
• An additional Abutment type: TPI Titanium Coping Abutments The TPI ● Titanium Coping Abutment design is based on Ditron's cleared Temporary Abutment. The TPI Titanium Coping Abutments are directly connected to the endosseous dental implant and are intended to provide a basis for prosthetic restoration of single (Crown) or multiple teeth (Bridge). The TPI Titanium Coping Abutment is available in several lengths and restoration options: 11.0mm Bridge, 11.0 Crown, 4.5mm Bridge, 4.5mm Crown.
• An additional Abutment type: TPI Overdenture Liberator Abutment The TPI ● Overdenture Liberator Abutment design is based on Ditron's cleared Liberator Abutment. The Liberator Abutment is available in several length dimensions of 2.0, 3.0, 4.0 and 5.0mm.

I am sorry, but the provided text focuses on the substantial equivalence of the "Ditron Dental Implants and Abutments" against predicate devices, primarily discussing changes and additions to the product line and the non-clinical testing performed to support their substantial equivalence for FDA clearance.

The document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria for aspects like:

1. A table of acceptance criteria and reported device performance: While there's a substantial equivalence table, it compares features and does not list specific acceptance criteria with reported device performance values for a study.
2. Sample size used for the test set and data provenance: The document mentions non-clinical tests but does not specify sample sizes for test sets (e.g., how many implants were used for fatigue testing, beyond stating "worst case configuration"). It also doesn't discuss data provenance in terms of country of origin or retrospective/prospective for a clinical study.
3. Number of experts used to establish ground truth and their qualifications: This type of information is relevant for studies involving human interpretation (e.g., image analysis devices), which is not the nature of this submission.
4. Adjudication method for the test set: Similarly, this is not applicable here as there isn't a "test set" requiring expert adjudication in the context of device performance in a clinical or reader study.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size: This type of study is for evaluating human performance with and without AI assistance, which is not applicable to dental implants and abutments.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
7. Type of ground truth used: For physical device testing, ground truth refers to validated measurements or established standards (e.g., ISO standards for fatigue). The document states tests were conducted "with accordance to ISO 14801" for fatigue, but doesn't elaborate further on a "ground truth" as might be understood in AI/clinical studies.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document primarily demonstrates that the new dental implant and abutment variations are substantially equivalent to previously cleared devices based on their identical or similar indications for use, technological characteristics (materials, design, sterilization), and non-clinical performance data (biocompatibility, sterilization validation, surface testing, fatigue testing, shelf life, MRI compatibility). The non-clinical tests performed served to ensure the safety and effectiveness of the new devices align with the predicate devices and established standards.

Therefore, I cannot extract the specific information you requested from the provided text for a "study that proves the device meets the acceptance criteria" in the format you outlined.

Ask a specific question about this device

BioHorizons implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures.

BioHorizons Tapered Internal 3.0, Tapered Tissue Level 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Intra-Lock implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

Intra-Lock 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandbular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion, (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.

Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

MILO™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function. They are also indicated for the rehabilitation of single maxillary lateral incisors and mandibular lateral incisors. The implants may be restored after a period of time or placed in immediate function.

BioHorizons Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

BioHorizons Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.

BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) 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; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm and 5.7mm internal hex-connection mating platform diameters. All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

Intra-Lock Prosthetics are abutments that include healing abutments for contouring tissue and final restorative abutments to support a prosthesis. The abutments may be used for a single or multiple unit restoration and are compatible for use with Intra-Lock implants.

Intra-Lock Titanium Base Abutments and Laser-Lok Titanium Base Abutments are intended to be used as straight abutments.

Intra-Lock CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) 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; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Intra-lock implants. All digitally designed abutments and/or copings for use with Intra-Lock CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. Intra-Lock abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

The MILO and Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

Not Found

The provided text is a clearance letter and Indications for Use statement for BioHorizons dental implants and abutments regarding their MRI compatibility. It does not contain any information about an AI/ML device, its acceptance criteria, or performance studies. Therefore, I cannot extract the requested information.

The document pertains to the regulatory clearance of a medical device (dental implants) for use in an MRI environment, not an AI or machine learning product. It describes the physical characteristics and intended use of the implants in a traditional medical context.

To provide the requested information, a document describing an AI/ML device and its validation studies would be necessary.

Ask a specific question about this device

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.

Ask a specific question about this device