Search Results

Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of 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 surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.

Zi Transmucosal Cover Screw and Healing:
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 surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing 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 multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Abutment Replacement Screw:
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.

Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C 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.

This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.

The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.

The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.

The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.

The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.

The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A

All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.

The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.

Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:

Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System

The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.

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

As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.

Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.

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Indications for Use for Helix Short Implant:

The Neodent Implant System is recommended for surgical procedures on maxilla or mandible bones. It provides support for prosthetic components such as artificial teeth, thus restoring the 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 Mini Straight, Angled Abutment and screws:

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 Helix Short Attachment:

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 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 Helix Short Healing Abutment:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Healing Abutment may be used in the implant installation surgery or the reopening surgery (second surgical stage).

Indications for Use for Helix Short Cover Screw:

This product is used for the maintenance of soft tissue, during the bone integration stage of Neodent implants to be rehabilitated with the late loading technique. The Cover Screw must remain intragingival, preventing the growth of tissue over the implant platform. The Cover Screw takes place in the conical region of the implant interface.

Indications for Use for Temporary Abutment for Helix Short Implant

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 procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Temporary Abutments are installed over Helix Short Implants and to provide support for prosthetic structures for up to 6 months.

Indications for Use for Helix Short Titanium Base:

The Helix Short Implant Titanium base that is placed over Neodent dental implants to provide support for customized prosthetic restorations, such as copings and crowns. It is indicated for single- and multiple-structure restorations, screw- or cement-retained on implants installed in the maxilla or mandible. All digitally-designed copings and/or crowns to be used with the Neodent Titanium Base System must be sent to Straumann for manufacture at a validated milling center.

• All the subject devices are intended for single use;
• The subject implants are provided sterile via gamma irradiation and the subject abutments are provided sterile via Ethylene Oxide to an SAL of 1x10-9;
• The subject implants are manufactured of Commercially Pure Titanium (Grade 4), the subject abutments, prosthetic screws and abutment screws are manufactured of Titanium alloy Ti-6Al-4V ELI (ASTM F136) and the restorations placed onto Helix Short Titanium Bases are made of various top half materials.
• The subject implants have a wide cone prosthetic interface with an internal hexagon for short implants lengths available from 4.0 to 7.0; cylindrical shape with double threads and conical apex with three helical flutes for diameters from 3.75 to 7.0mm.
• The implants are provided in two different surfaces: Neoporos: Sand blasted and acid etched, and Acqua: Hydrophilic surface aggregated to the rough surface obtained by double treatment: abrasive blasting and acid subtraction.
• The Helix Short Implant Titanium Base abutments is used as two-piece abutment, where the base is premanufactured from titanium alloy and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The final top half can be created from Ticon, Coron, Zerion LT, IPS e.max, or PMMA. The top half and base pieces are cemented together to form the final abutment.

Here's an analysis of the acceptance criteria and supporting studies for the Neodent Implant System - Helix Short Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly present a table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it describes what was tested and states that the results "met the acceptance criteria" or demonstrated "equivalent performance." We can infer the general acceptance criterion from the study descriptions.

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

The document does not explicitly state the numerical sample size for the test sets in the mechanical, MR compatibility, or other in-vitro studies. It refers to "tested subject devices" or "representative samples."

• Data Provenance: The studies described (mechanical testing, MR compatibility, surface treatment, sterilization, endotoxin, shelf life, biocompatibility) are all benchtop/laboratory studies (in vitro). There is no mention of human subject data, animal data, or clinical retrospective/prospective data for these specific performance criteria. The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil.

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

Not applicable. As these are benchtop/laboratory performance studies, "ground truth" is established by adherence to recognized standards (e.g., ISO 14801, ISO 11137, ISO 11135, ISO 10993) and scientific methods, not by expert consensus in the typical sense for clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for interpreting clinical images or patient outcomes, not for objective benchtop performance data against engineering 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

Not applicable. This device is an endosseous dental implant system, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Adherence to International Standards: Performance measured against specifications outlined in standards like ISO 14801 (dynamic fatigue), ISO 11137 and ISO 11135 (sterilization), ISO 10993 series (biocompatibility).
• Benchtop Test Results: Direct measurements and observations from the mechanical, physical, chemical, and biological laboratory tests performed on the device.
• Comparison to Predicate Devices: Performance is frequently established by demonstrating equivalence or superiority to already legally marketed predicate devices, which serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concepts of "training set" and "validation set" are primarily used for machine learning and AI, not for the regulatory approval of physical implants based on benchtop testing.

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

Not applicable for the same reasons as point 8.

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Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.

Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for:

• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222.

The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.

The provided text does NOT describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing (such as AI assistance effect size, ground truth for training/test sets, sample sizes for training/test sets, adjudication methods, and expert qualifications) cannot be extracted or fulfilled.

The document pertains to the 510(k) summary for Straumann® 4 mm Short Implants, a medical device, and the evaluation details focus on the physical and mechanical performance of the implant, biocompatibility, sterilization, and clinical literature review of implant survival rates, not on an AI system's performance.

Therefore, the table of acceptance criteria and reported device performance, and the other requested information points are not applicable in the context of an AI/ML device. The document describes a dental implant, not an AI or imaging device.

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• HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
• Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
• Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
• Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
• CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
• GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
• GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
• . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

• Titamax WS implants, abutments and copings (originally cleared per K123022)
  The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Titamax WS implants are indicated for a delayed loading protocol.

• Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
  The implants, abutments and copings of the Neodent Implant System are 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. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

• Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
  The Zygomatic implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.

• CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
• o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base 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 are intended to be sent to Straumann for manufacture at a validated milling center.

• CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
  The implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are 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 for CEREC Abutment 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.

• CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
  The implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
• CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)

The implants, abutments and copings of the Neodent Implant System are 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. Multiple tooth applications may be rigidly splinted.

The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
  The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

• . The Neodent Graft Screw (originally cleared per K103084)
  The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA regarding the MRI compatibility of various Neodent Implant System devices. It primarily focuses on defining the indications for use for different components of the implant system and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/Medical Device.

The document is a regulatory approval letter and descriptive indications for use, not a study report or technical performance assessment. Therefore, I cannot extract the requested information from this text.

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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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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, Silicone Seal, Titanium Coping, Temporary Cap, abutment screws, and Smileloc Activator (or Smileloc Remover). 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.

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 200 P and 500 D series are designed for multi-unit restorations only, 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 0 3.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided document is a 510(k) summary for the Rodo Abutment System, a dental device. It outlines the device's indications for use, its classification, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of algorithm-based metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/ML device.

The closest information available that might relate to "acceptance criteria" for a medical device (not specifically an AI/ML device) typically involves demonstrating substantial equivalence to a legally marketed predicate device through various tests and comparisons.

Here's an analysis based on the provided document, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical dental abutment system and not an AI/ML device, there are no specific performance metrics like sensitivity, specificity, or accuracy mentioned as "acceptance criteria" for an algorithm. Instead, the "performance" is demonstrated through various non-clinical and clinical tests to show safety and effectiveness and substantial equivalence to predicate devices.

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

• Sample Size (Clinical Trial): 34 subjects were enrolled, 32 subjects received Rodo Abutments and restorations. Out of these, 3 subjects received 4 abutments each as part of full arch treatment, resulting in a total of 41 Rodo Abutments placed and restored.
• Data Provenance: The document states, "A prospective multi-center clinical trial... was conducted under an Investigational Device Exemption study according to FDA guidelines." This indicates it's prospective data. The document does not explicitly state the country of origin, but given the FDA submission context, it's presumed to be a US-based study or at least data acceptable for US regulatory purposes.

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

This information is not provided in the document. For a physical device like a dental abutment, "ground truth" might refer to clinical outcomes assessed by trained dental professionals, but the study description does not detail the number or qualifications of experts involved in assessing device performance or generating the "ground truth" of safety and effectiveness outcomes beyond the medical staff conducting the trial.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically relevant for studies where multiple readers interpret data and discrepancies need to be resolved, which is common in imaging studies for AI/ML devices. For a clinical trial of a physical implant, such a method for "test set" adjudication is not typically described in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic performance, often of AI/ML systems or diagnostic tests, comparing multiple readers' interpretations of cases. The Rodo Abutment System is a physical dental device.

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

No, a standalone algorithm performance study was not done. The Rodo Abutment System is a physical dental device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for evaluating the Rodo Abutment System's safety and effectiveness was based on clinical outcomes data from human subjects who received the device. This included:

• Observation of adverse events (e.g., abutment screw loosening, crown separation, non-device related events).
• The overall clinical assessment that the system "provides an appropriate method of attaching prosthetic restorations to dental implant abutments" and "if necessary, it allows repeated removal of the restoration."

For non-clinical tests, the "ground truth" was based on engineering standards and direct measurement/testing results (e.g., SAL for sterility, acceptable ranges for biocompatibility, mechanical strength, corrosion resistance).

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical and non-clinical data collected serve as validation for the device's design and manufacturing rather than training an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when stability is achieved and with appropriate occlusal loading.

This submission includes threaded root-form dental implants designed for placement into the zygomatic bone with either an external hexagon abutment interface, or a Morse taper abutment interface. Both implant designs are provided with a thread major diameter of 4.4 mm at the coronal end of the implant (over a length of 10 mm), which tapers to a thread major diameter of 3.9 mm for the remaining implant length. Both implant designs are provided in multiple threaded lengths ranging from 30 mm to 52.5 mm. All implants are made of commercially pure titanium, Grade 4, conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

This submission includes transepithelial abutments with external hexagon or Morse taper interfaces for connection to the zygomatic implants. The external hexagon abutments have a platform diameter of 4.1 mm and are provided in gingival heights of 3, 4, or 5 mm. The Morse taper transepithelial abutments also have a platform diameter of 4.1 mm and are provided in gingival heights of 1.5, 2, 3, 4, or 5 mm.

This submission also includes a Protection Cylinder that is used to protect the abutment during healing of the gingival tissue. The Protection Cylinder may be installed on either abutment design (external hexagon or Morse taper) with the corresponding Protection Cylinder Screw.

All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All zygomatic implants are packaged assembled with the corresponding implant mount and provided sterilized by gamma irradiation. All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are provided sterilized by exposure to ethylene oxide.

The provided text describes a submission for a Neodent Implant System to the FDA for 510(k) clearance, asserting its substantial equivalence to previously marketed predicate devices. This type of submission focuses on comparing a new device to existing ones rather than proving the device meets specific acceptance criteria through a clinical trial with a defined ground truth and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria met by a study, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the training set.

Instead, the document details:

• Non-clinical data: Biocompatibility, engineering analysis, dimensional analysis, and dynamic compression-bending testing according to ISO 14801. These are physical and material property tests to ensure the device meets certain strength and safety standards, but are not "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI/algorithm-based device.
• Clinical literature data: This is a review of existing data rather than a prospective study designed to meet specific performance criteria for the subject device.

Here's what can be extracted, acknowledging the limitations regarding "acceptance criteria" in the AI/algorithm sense:

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

The document does not specify "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, accuracy, etc., for a diagnostic or AI device. Instead, the "performance" demonstrated is a comparison to predicate devices, where the primary outcome considered is implant survival rates.

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

• Subject device (test set, as per clinical literature):
  • Sample Size: 16 subjects with a total of 37 zygomatic implants.
  • Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.
• Predicate device (comparison in clinical literature):
  • Sample Size: 45 subjects with a total of 90 zygomatic implants and 165 conventional dental implants.
  • Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.

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

Not applicable. This was a review of clinical literature data focusing on implant survival, not an expert-adjudicated test of an AI/algorithm's performance. The "ground truth" would implicitly be the observed clinical outcome (implant survival/failure) as reported in the literature, which is based on clinical assessment by treating physicians.

4. Adjudication method for the test set

Not applicable, as it's a review of clinical literature data, not an expert adjudication process for algorithmic output.

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 submission is for a physical medical device (dental implants), not an AI/algorithm where human reader performance would be a relevant metric.

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

Not applicable. This is not an AI/algorithm device.

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

The "ground truth" implicitly used for the clinical literature data was outcomes data (implant survival/failure) as observed and reported in the clinical studies.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm and therefore does not have a "training set."

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

Not applicable. There is no training set for this device.

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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.

PreFace Abutment 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. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.

PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.

The subject abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.

The provided text is a 510(k) Summary for the Neodent Implant System. It describes a medical device approval and focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert consensus.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert qualifications, and ground truth are not present in this type of regulatory document.

However, I can extract information related to performance data and comparison to predicate devices, which serve as a form of "acceptance criteria" in the context of substantial equivalence.

Here's an attempt to answer your request based on the provided document:

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

In the context of a 510(k) submission, "acceptance criteria" are typically demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics and performance data. The reported "performance" is that the new device is at least as good as, or substantially equivalent to, the predicates.

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

• Sample Size for Test Set: Not specified in the document. The performance data mentioned are "non-clinical" (biocompatibility, engineering analysis, dimensional analysis, mechanical testing, sterilization testing). For mechanical testing (ISO 14801), sample sizes are not detailed, but such standards typically require a specific number of samples for statistically valid testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification from a Brazilian manufacturer (JJGC Indústria e Comércio de Materiais Dentários SA) to the U.S. FDA, meaning the testing data would typically be generated by or for the manufacturer. The data is non-clinical, likely from laboratory testing. It is not clinical data (no "retrospective or prospective" clinical studies are mentioned).

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 and not provided in the document. The document describes a medical device (dental implant abutments) that undergoes non-clinical engineering and material testing, not diagnostic performance evaluation requiring ground truth established by experts.

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

• This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or performance evaluations where there's subjectivity and disagreement among reviewers (e.g., in imaging interpretation). The tests described are objective, non-clinical tests (e.g., mechanical fatigue, sterilization parameters).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices that assist human interpretation, which is not the nature of the dental implant abutments described.

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

• No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The "performance data" refers to the physical and material properties of the abutments.

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

• This information is not applicable and not provided in the document as it pertains to non-clinical engineering and material testing. The "ground truth" for mechanical testing, for example, would be the physical measurement of failure points or fatigue limits compared against a standard. For biocompatibility, it's compliance with ISO standards.

8. The sample size for the training set

• This information is not applicable and not provided in the document. There is no AI or algorithm involved that would require a "training set."

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

• This information is not applicable and not provided in the document as there is no training set mentioned.

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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. Multiple tooth applications may be rigidly splinted.

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945 and K123022. This submission includes Facility Universal Post and Equator Attachment CM abutments with a Morse taper interface. Facility Universal Post abutments are straight, post-type abutments for cemented prosthetic restorations. They are provided in one platform diameter (3.3 mm), gingival heights of 1 mm to 5 mm, and prosthetic heights of 4 mm and 6 mm. Facility Universal Post abutments are compatible with the Facility dental implants cleared in K123022, and with the Universal Post Cylinders cleared in K101945. Equator Attachment CM abutments are straight, ball-type abutments for the attachment of overdentures or partial dentures. They are provided in five gingival heights (1.5, 2.5, 4.5 and 5.5 mm). These abutments have a titanium nitride (TiN) coating for the purpose of creating a harder surface to increase wear resistance. This titanium nitride coating is identical to that used on the Neodent CM Mini Ball Attachment cleared in K101945, and the Facility Equator Attachment cleared in K123022. Equator Attachment CM abutments are compatible with Titamax CM, Titamax CM EX, and Alvim CM implants cleared in K101945, and with the CM Drive implants cleared in K123022. All abutments in this submission are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The provided text is a 510(k) Summary for the Neodent Implant System. It outlines the device description, its intended use, and its equivalence to previously marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone) related to the Neodent Implant System.

The 510(k) summary explicitly states: "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Clinical data were not submitted in this premarket notification."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical data, rather than presenting a performance study with acceptance criteria.

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