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Indications for Use for GM Helix Implants and conventional abutments:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for Use for GM Exact Titanium Block for Medentika Holder:
GM Exact Titanium Block for Medentika Holder is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. The GM Exact Titanium Block for Medentika Holder abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed abutments for use with the GM Exact Titanium Block for Medentika Holder are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for GM Exact Titanium Base abutments:
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for Use for Titanium Base C for GM Exact abutments:
The Titanium Base C for GM Exact abutments is a titanium component that is placed over Neodent implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations.
All digitally designed copings and/or crowns for use with the Titanium Base C for GM Exact abutments are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes: GM Helix Implant in diameter (6 mm), overall lengths of 8 mm to 13 mm, and in two endosseous surfaces, grit-blasted and acid etched (NeoPoros) and hydrophilic surface (Acqua); GM Customizable Healing Abutment in two prosthetic diameters (5.5 mm and 7.0 mm), each in multiple gingival heights (ranging from 1.5 mm to 6.5 mm); GM Exact Titanium Block for Medentika Holder titanium blank abutment, in two milling diameters, 11.5 mm and 15.8 mm; GM Exact Titanium Base in one prosthetic diameter (5.5 mm), six gingival heights (from 0.8 mm to 5.5 mm), and two prosthetic post heights (4 mm and 6 mm); and Titanium Base C for GM Exact one prosthetic diameter (4.65 mm), 6 gingival heights (from 0.8 mm to 5.5 mm), and one prosthetic post height (4.7 mm).
The GM Exact Titanium Base and Titanium Base C for GM Exact are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the GM Exact Titanium Base and Titanium Base C for GM Exact are two piece abutments used as a base when fabricating a CAD/CAM customized restoration. The GM Exact Titanium Base C for GM Exact are provided in an anti-rotational shape for the coupling with the prosthesis and are available in diameters of 4.65 mm (Titanium Base C for GM Exact) and 5.5 mm (GM Exact Titanium Base), and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5 mm. The planning and milling of the customized superstructures must be made using the validated Dental Wings Operating System (DWOS) or 3Shape software. All digitally designed copings and/or crowns for use with the GM Exact Titanium Base and Titanium Base C for GM Exact are intended to be manufactured at a validated milling center. The limits for customization are stated in the GM Exact Titanium Base and Titanium Base C for GM Exact product IFU. The superstructure produced through CAD/CAM System will compose the second part of the two-piece abutment; the assembly becomes a finished medical device after cementation on the GM Exact Titanium Base or Titanium Base C for GM Exact. The GM Exact Titanium Base is indicated for screw-retained single-unit, or cement-retained single or multi-unit prosthesis attachment onto implants. The Titanium Base C for GM Exact is indicated for cement-retained single-unit prosthesis attachment onto implants.
The subject device abutments components mate exclusively with the GM implants cleared in K163194.

The provided text is a 510(k) Summary for the Neodent Implant System - GM Line. It outlines the device's indications for use, description, and a comparison to predicate devices to demonstrate substantial equivalence, rather than directly detailing acceptance criteria and performance data in the format requested.

Here's an analysis based on the information provided, trying to extract details relevant to your request, but please note that some of your requested information might not be explicitly present in this type of FDA submission summary:

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

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance outcomes in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data from non-clinical studies (e.g., mechanical testing).

The "performance data" reported are primarily focused on safety and mechanical integrity, rather than a clinical performance metric.

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

The document indicates that no clinical data were submitted in this premarket notification. The "test set" for performance was based on non-clinical data, primarily engineering and mechanical testing.

• Sample size for mechanical testing (ISO 14801): Not explicitly stated in terms of number of samples, but implied to be sufficient for demonstrating compliance with the standard and substantial equivalence. The document mentions "worst-case subject device constructs."
• Data provenance: Non-clinical (laboratory testing). No information on country of origin of data, as it's not a clinical study.

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

This information is not applicable as there was no clinical study and thus no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The ground truth for mechanical testing is defined by the test standards (e.g., ISO 14801 parameters).

4. Adjudication method for the test set

This information is not applicable as there was no clinical study involving human judgment requiring an adjudication method.

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 information is not applicable. The device is an endosseous dental implant system, not an AI-assisted diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the performance evaluation in this submission is established through:

• International standards and regulatory guidelines: For sterilization (ISO 11137 series, ISO 11135, ISO 10993-7, ISO 17665-1, ISO 17665-2), bacterial endotoxin (AAMI/ANSI ST72), sterile barrier shelf life (ASTM F1980, ASTM E499/E499M, ASTM F1929, ASTM F88/F88M, ISO 11737), biocompatibility (ISO 10993 series, implied by referencing K163194), and mechanical testing (ISO 14801).
• Comparison to predicate devices: Demonstration of identical or similar materials, design, and intended use as legally marketed devices.

8. The sample size for the training set

This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

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

This information is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device. The "ground truth" for demonstrating substantial equivalence of the physical components is based on established engineering principles, materials science, and conformity to relevant international standards, effectively using the performance of the predicate devices as a benchmark for what is considered safe and effective for the described indications.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes the GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The subject device components mate exclusively with the GM implants cleared in K163194.

The GM Exact Co-Cr Abutment for Crown is provided in three sizes to fit the prosthetic diameter sizes of the GM implants cleared in K163194. The subject device abutments consist of a Co-Cr alloy component that interfaces directly to the implant and a cvlinder of polyoxymethylene (POM) for fabrication of a cast prosthesis by a burn-out technique. The subject device abutments are provided in three (3) sizes to match the various platforms of the mating GM implants: 3.5/3.75 mm platform diameter, 4.0/4.3 mm platform diameter, and 5.0/6.0 mm platform diameter. The subject device abutments are for single-unit prosthetic restorations only. The final prosthetic restoration may be cement-retained or screw-retained.

The GM Equator Attachment abutments are straight, ball-type abutments for the attachment of full or partial overdentures. GM Equator Attachments are provided in five gingival heights (1.5, 2.5, 3.5, 4.5, and 5.5 mm), and may be used with all GM implant diameter sizes cleared in K163194.

The subject device GM Exact Co-Cr abutments are made of Co-Cr alloy conforming to ASTM F1537, with mating abutment screws made of titanium alloy conforming to ASTM F136. The GM Equator Attachments made of titanium alloy conforming to ASTM F136 with a TiN coating identical to the TiN coating cleared in K133696.

This document describes the Neodent Implant System - GM Line, specifically introducing new abutment components. Based on the provided text, the acceptance criteria and study information are focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The document mainly uses non-clinical performance data (biocompatibility, sterilization validation, shelf-life, bacterial endotoxin testing) to support this claim.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., accuracy, sensitivity, specificity, or clinical outcomes). Instead, the performance data presented is aimed at demonstrating the device's characteristics are comparable to predicate devices. The "performance" is primarily shown through a comparison of technological characteristics and non-clinical testing results to existing standards and predicate devices to establish substantial equivalence.

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 focuses on non-clinical testing and refers to standards. It does not specify "sample sizes" in the context of clinical test sets or patient data.

• Sample size for testing: Not explicitly stated for each non-clinical test (e.g., number of abutments tested for biocompatibility or number of packages for shelf-life). However, regulatory standards (like ISO 10993, ISO 17665-1) inherently require specific sample sizes for valid testing.
• Data Provenance: The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. based in Curitiba, Paraná, Brazil. The non-clinical testing would presumably have been conducted by or commissioned by this company, possibly in Brazil or by certified labs internationally. The data is non-clinical, not from human subjects, hence "retrospective or prospective" does not directly apply in the clinical sense.

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)

This information is not applicable. The provided document details the submission for new components of an existing dental implant system, demonstrating substantial equivalence through non-clinical testing (biocompatibility, sterilization, material specifications). It does not involve diagnostic imaging or other subjective assessments that would require expert consensus for ground truth.

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

This information is not applicable, as there is no clinical test set requiring adjudication in the context of diagnostic interpretation or outcomes.

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 information is not applicable. The device is a dental implant system (hardware), not a diagnostic AI device. Clinical data was explicitly not submitted: "Clinical data were not submitted in this premarket notification." Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant to this submission.

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

This information is not applicable. The device is a dental implant system (hardware), not an algorithm or AI device.

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

For the non-clinical performance data, the "ground truth" or reference for evaluating compliance consists of:

• International Standards: ISO 10993 series (biocompatibility), ISO 17665-1, ISO TS 17665-2, ISO 11135, ISO 10993-7 (sterilization), AAMI / ANSI ST72 (bacterial endotoxin testing).
• Material Standards: ASTM F1537 (Co-Cr alloy), ASTM F136 (Ti-6Al-4V alloy).
• Predicate Device Characteristics: Comparison of physical dimensions, design principles, intended use, and materials to established predicate devices (K163194, K101207, K121843, K133696) to demonstrate substantial equivalence.

There is no "ground truth" in the sense of clinical expert consensus, pathology, or outcomes data, as clinical data was not submitted.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device (dental implant components), not a machine learning or AI algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for an algorithm.

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Indications for Use for GM implants and conventional abutments:

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Indications for Use for GM Titanium Base abutments:

Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Indications for Use for GM Pro Peek Abutments:

The Pro PEEK Abutments are indicated to be used on Neodent 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.

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line.

The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows:

The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment:

NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface.

Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface.

GM Titamax implants: cylindrical shape with double threads of pyramidal profile, rounded apex.

GM Helix implants: conical shape, double threads with trapezoidal profile, a rounded apex.

GM Drive implants: conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex.

The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible.

GM Cover Screws: devices for temporary use during the implant healing phase.

GM Healings: devices for temporary use for maintenance of the soft tissue during the osseointegration phase.

GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Click Universal Abutments (straight and angled): intermediary prosthetic components to be installed onto GM implants to support the final prosthesis.

GM Exact Titanium Base abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration.

GM Pro PEEK Abutment: temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months.

Protection Cylinders: prosthetic components with a tapered shape intended to be placed on abutments to protect them during the fabrication of the prosthesis and/or healing of the peri-implant tissues.

Coping Screws: prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment.

This document is a 510(k) Premarket Notification from the FDA regarding the "Neodent Implant System - GM Line." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in a clinical or performance study context.

Therefore, the information requested in your prompt (Acceptance Criteria, Study Design for proving performance, Sample Sizes, Expert consensus, MRMC studies, etc.) is not present in this document. This document details the comparison of the new device with existing ones based on:

1. Indications for Use: The new device's indications align with or are subsumed by those of the predicates.
2. Technological Characteristics: Materials, design features, sterilization methods, and compatibility are compared.
3. Performance Data (Mechanical Testing and Biocompatibility): This section confirms that the materials meet established standards (ASTM, ISO) and that the device components (implants, abutments) have undergone mechanical fatigue testing according to ISO 14801 and FDA guidance. Biocompatibility has been assessed for the materials used. However, it does not provide specific acceptance criteria or detailed results of these tests, simply stating that the performance is "equivalent" to predicate devices.

Summary of missing information based on your prompt:

• Table of acceptance criteria and reported device performance: Not provided in a quantifiable manner for clinical performance. Only mentions "equivalent" mechanical performance based on ISO standards.
• Sample sizes for test set and data provenance: No clinical test set involving human subjects is described. Mechanical tests likely involved specific numbers of devices, but these are not disclosed.
• Number of experts and qualifications for ground truth: Not applicable as no clinical ground truth assessment is detailed.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not conducted or reported. This submission relies on substantial equivalence to existing devices, not a comparative clinical trial with human readers/outcomes.
• Standalone performance (algorithm only): Not applicable as this is a physical medical device (dental implant system), not an AI algorithm.
• Type of ground truth used: For regulatory purposes, the "ground truth" for this submission is established through comparison to legally marketed predicate devices and adherence to relevant industry standards (ISO, ASTM) and FDA guidance for mechanical and biocompatibility testing. No clinical "ground truth" derived from patient outcomes or expert consensus on images is mentioned regarding the device's function.
• Sample size for training set: Not applicable as this is not an AI/ML device.
• How ground truth for training set was established: Not applicable.

In conclusion, this document demonstrates regulatory compliance and substantial equivalence through a comparison of device characteristics and a statement of meeting mechanical and biocompatibility standards, rather than presenting a detailed study proving the device meets specific, quantifiable clinical acceptance criteria.

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