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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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The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

The NobelProcera Zirconia Implant Bridge (Dental Bridge) is a patient-specific, dental implant supported, screw-retained dental implant bridge which is connected to compatible Nobel Biocare root-form endosseous dental implants (Dental Implants) or Multi-unit Abutments and is intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. The Dental Bridge is made from yttria-stabilized tetragonal zirconia. It is designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. The Dental Bridge is available for use with Nobel Biocare's Dental Implants having Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment connections. One Dental Bridge can feature connections to 2 up to 10 Dental Implants. All Dental Bridges are provided with the required Clinical and/or Prosthetic Screw: The Clinical Screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connects the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the External Hex, Internal Tri-Channel, or Multi-unit Abutment connections. Clinical and Prosthetic Screws are placed from the occlusal side of the restoration. To facilitate access to the connection of the restoration to the implant/abutment a screw channel must be designed into the restoration. The Dental Bridge feature an Angulated Screw Channel (ASC) when connected to a Dental Implant with Internal Conical Connection and has an ASC feature to connect to Multi-unit Abutments. NobelProcera Zirconia Implant Bridges ASC's angulation can be defined by the customer in an angulation (to the implant's or Multi-unit Abutment's axis) between 0° and 25°. The ASC allows access through a screw channel which is not in line with the implant.

The provided text is a 510(k) summary for the NobelProcera Zirconia Implant Bridge. It describes the device, its indications for use, and a comparison to a predicate device.

However, the document states: "Clinical data is not required to establish substantial equivalence for the Subject Device. Non-clinical test data was conducted in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'. This testing involved examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing."

This indicates that a clinical study with acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, or MRMC studies for AI performance was not part of the submission for this particular device. The evaluation relied on non-clinical (bench) testing, specifically fatigue testing, to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information from the provided text as it pertains to clinical studies or AI performance. The document only mentions "fatigue performance testing" as the evidence for the revised extension length.

To answer your request, here's what can be extracted and what cannot:

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

• Acceptance Criteria: While not explicitly listed as a "table of acceptance criteria" in the format usually requested for clinical studies, the document implies that the device's performance regarding "extension length" was evaluated through fatigue testing. The revised extension length of 16mm (for the subject device) versus 10mm (for the predicate device) suggests an acceptance criterion related to the ability to withstand fatigue at this increased length. The wording "fatigue performance testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness" implies that the device successfully met the fatigue requirements for the 16mm extension.
• Reported Device Performance: The document states that "The revised extension length is supported by the fatigue performance testing provided in the premarket notification." and "fatigue testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness." This indicates that the subject device, with its maximum extension length of 16mm, passed the non-clinical fatigue tests, demonstrating performance equivalent to or better than the predicate device.

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

• Not applicable for a non-clinical fatigue test. The testing involved "examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing." The number of units tested is not specified in this summary. Data provenance is not relevant for bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. This was a non-clinical, benchtop fatigue test, not a study requiring expert ground truth for clinical interpretation.

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

• Not applicable. This was a non-clinical, benchtop fatigue test.

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. This device is a dental implant bridge, not an AI-powered diagnostic or assistive tool.

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

• No. This device is a physical medical device, not a software algorithm.

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

• Not applicable for non-clinical fatigue testing. The "ground truth" for fatigue testing would be the physical measurement of failure or deformation under specified loading conditions, and comparison against a defined standard or predicate performance.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device and non-clinical testing, not an AI algorithm requiring a training set.

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

• Not applicable. See point 8.

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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 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. Healing,

The Zirconia Base is an abutment placed over Neodent Zirconia Implants 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.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The Zirconia Abutments subject of this submission are similar to devices already approved in previous submissions of Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Zirconia Abutments with new dimensions of gingival height for Zirconia Healing Abutments, Zirconia Bases, CR Abutments for Zirconia and PEEK CR Abutments for Zirconia, to provide more treatment options to the customers. 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. The new transmucosal heights are 3.5mm and 4.5mm.

The restorative materials Polycon ae, N!ce and IPS e.max CAD LT were not presented in previous submissions of Zirconia Implant System and are being included in the scope of Zirconia Bases indication.

The provided document is a 510(k) summary for the Neodent Implant System - Zirconia Implant System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and expert adjudication as might be seen for novel AI/software as a medical device (SaMD) products.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods for training sets.

The performance testing section (pages 14-15) describes:

• Bench Testing:
  • Dynamic fatigue testing: Conducted according to FDA guidance and ISO 14801. The results demonstrated the subject devices do not introduce a new worst case compared to predicate and reference devices.
  • Torsion tests: Performed to evaluate screw strength, and results proved adequate torsion strength according to installation torque.
• Biocompatibility Testing:
  • Assessment performed according to ISO 10993-1 and FDA guidance. No new issues were raised and no additional testing was required because the subject devices are identical in material and manufacturing processes to predicate and reference devices.
• Sterilization Validation and Packaging:
  • Ethylene Oxide (EO) sterilization validated to SAL of 10-6 per ISO 11135:2014. EO residuals verified per ISO 10993-7. The packaging and sterilization are identical to predicate devices.
  • Steam sterilization validated per ISO 17665-1, using parameters identical to predicate devices.
  • Pyrogen limit specifications met via LAL Endotoxin Analysis (testing limit 20 EU/device) for blood contacting and implanted devices.

In essence, the study presented is a non-inferiority or equivalence-based assessment against previously cleared devices, focusing on engineering and biocompatibility characteristics, not clinical performance metrics or AI algorithm validation metrics.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document describes a traditional medical device (dental implants and abutments) clearance, not a software or AI device that would have the specific performance study criteria outlined in your request.

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The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific 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.

The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment. This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890).

The provided text describes the regulatory clearance of a dental implant system and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML device. Therefore, the information requested for an AI/ML device, such as specific acceptance criteria and detailed study designs involving test sets, ground truth establishment, and expert involvement, is not available in the provided document.

The document primarily discusses:

• Device: Neodent Implant System - Zirconia Implant System, specifically the Zirconia Base abutment.
• Purpose of Submission: To introduce a conventional workflow for manually designed prostheses using Zirconia Bases and to include a new restoration material (IPS e.max® Press).
• Method of Proof: Substantial Equivalence to legally marketed predicate devices, as per FDA 510(k) requirements. This involves comparing indications for use, technological characteristics, materials, and manufacturing processes, supported by performance data (mechanical testing, MR compatibility, sterilization validation, biocompatibility) demonstrating that the new workflow and material do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested tables and information as it pertains to AI/ML device acceptance criteria and study details. The document does not describe an AI/ML device or its evaluation.

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The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.

The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone. The implants come in corresponding diameters of 3.7 and 4.3 mm.

The provided text describes the Z7 Zirconia Implant System, a dental implant device, and its compliance with FDA requirements for substantial equivalence to a predicate device. However, the information you've requested regarding acceptance criteria and study details in the context of an AI/ML device is not present in this document.

The document is a 510(k) clearance letter for a medical device manufactured from Zirconia (an endosseous dental implant), not an AI/ML-driven medical device. Therefore, it does not contain information about:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample size for test sets in an AI context
• Data provenance for AI training/testing
• Number/qualifications of AI ground truth experts
• Adjudication methods for AI ground truth
• MRMC studies for AI assistance
• Standalone AI algorithm performance
• Type of ground truth used for AI
• Training set sample size for AI
• Ground truth establishment for AI training

The performance testing summarized in the document (Page 7) is related to the physical and material properties of the dental implant itself:

• Material Performance Testing: Per ISO 13356:2015 for Yttria-stabilized tetragonal zirconia (Y-TZP).
• Fatigue Testing: Per ISO 14801:2016 for dynamic loading of endosseous dental implants.
• Implant Surface Roughness and Chemical Analysis Validation: Through 3D Scanning Electron Microscope (SEM) Imaging and Energy Dispersive Spectrometry (EDS Analysis).
• Biocompatibility: According to ISO 10993-1 and ISO 10993-5 (cytotoxicity).
• Endotoxin Testing: Following USP and USP.
• Sterilization Validation: Per ISO 11135:2014 (Ethylene Oxide) and ISO 17665 (Moist Heat) for sterility assurance level (SAL) of 10^-6.
• Shelf-Life Validation: Accelerated aging followed by real-time aging.

For these physical device tests, all results are reported as "PASS" and "Device met all predetermined acceptance criteria" or "Substantially equivalent fatigue strength to reference device."

To reiterate, this document does not contain the information you are looking for regarding AI/ML device acceptance criteria and study details.

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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 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.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
• . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
• ZiLock prosthetic interface with internal indexer;
• Apically tapered implant with trapezoidal thread profile;
• Implant provided with sand-blasted, acid etched surface finish;
• . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
• . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.

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Neodent prosthetic abutments are indicated to be used on Neodent implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The subject device is a temporary abutment composed of PEEK with a titanium alloy fixation screw. The subject device is compatible with Neodent zirconia implant bodies with Zilock connection platform (K201491).

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard;
• . ZiLock prosthetic interface with internal indexer;
• . Cylindrical format with a passing hole to fixate the screw.

I apologize, but the provided text is an FDA 510(k) Pre-market Notification letter and a 510(k) Summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence of a new device (Neodent Implant System - Zirconia Implant System) to existing predicate devices.

This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

• The device's trade name, regulation number, and product code.
• Indications for Use.
• Comparison of technological characteristics between the subject device and predicate devices (e.g., intended use, design, materials, sterilization).
• Bench testing (biocompatibility, MRI compatibility) and sterilization validation, largely leveraged from predicate devices.

It does not describe an AI/ML-based device, nor does it provide the type of study details requested (e.g., expert ground truth, sample sizes for AI model testing/training, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, as this information is not present.

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Indications for Use for Zirconia Implants, Cover Screw and Healing Abutment:
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 singlestage 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.

Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific 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.

• Intended for single use;
• Zirconia implants provided sterile via Ethylene Oxide; Zirconia Base abutments are provided sterile but require end user sterilization via moist heat following cementation of the restoration and before use
• All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide), except for the Zirconia Implant Cover Screw and the Basal Screw, which is manufactured of titanium alloy according to ASTM F136 standard;
• ZiLock prosthetic interface with internal indexer;
• Apically tapered implant with trapezoidal thread profile;
• Implant provided with sand-blasted, acid etched surface finish to facilitate osseointegration.
• The final finished Zirconia Base abutments are two-piece abutments composed of a zirconia base bottom-half bonded to a CAD-CAM zirconia top-half.

The provided text describes a medical device submission (K201491) for the Neodent Implant System - Zirconia Implant System to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance results for a new AI/software device.

Therefore, the requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies cannot be extracted from this document as it pertains to a different type of medical device submission (dental implants and their components) and regulatory pathway (510(k) for substantial equivalence).

The document details the comparison of the subject device (Neodent Implant System - Zirconia Implant System) to predicate and reference devices in terms of indications for use, technological characteristics, and performance data from various tests. However, these are evaluations against established standards and comparisons to existing devices, not metrics of an AI's performance.

Here's what can be extracted, though it doesn't directly answer the detailed questions about AI performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria for software performance in the typical sense (e.g., sensitivity, specificity, AUC). Instead, it presents a comparison of technological characteristics and states that the "tested subject devices exhibit a level of performance equivalent to that reviewed for the predicate devices" in mechanical testing.

Here's a summary of the performance data presented, which implies meeting an "equivalent" performance to predicates rather than specific numerical acceptance criteria for a new software.

No information is available regarding points 2-9 as they are specific to AI/software device studies to establish performance against a ground truth. This document is a 510(k) summary for a physical dental implant system and components, establishing substantial equivalence to existing devices.

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The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Zirconia Implant Bridges (Dental Bridges) are patient-specific, dental implant supported, screw-retained dental implant bridges which are connected to compatible Nobel Biocare root-form endosseous dental implants or Multi-unit abutments and are intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing.

NobelProcera Zirconia Implant Bridges are made from 'Nacera Pean' (yttriastabilized tetragonal zirconia), Reference Device #1, K143071. The Dental Bridges are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo-approved dental scanner.

The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing.

NobelProcera Zirconia Implant Bridges are available for use with Nobel Biocare's root-form endosseous dental implants (Dental Implants) havinq Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment Connections (for MUA and MUA Plus). One Dental Bridge can feature connections to 2 to 10 Dental Implants.

All NobelProcera Zirconia Implant Bridges are provided with the required clinical and/or Prosthetic Screw: The clinical screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connect the Dental Bridge with a Multi-unit Abutment.

Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the external hex, internal tri-channel, or Multi-unit abutment connections.

The provided text is a 510(k) Summary for a medical device (NobelProcera Zirconia Implant Bridge) seeking substantial equivalence to a predicate device. It describes performance testing but does not present the specific acceptance criteria or the reported device performance in a table, nor does it detail a study designed to directly prove the device meets pre-defined acceptance criteria in the manner requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and performance data. The performance data mentioned are from fatigue testing and biocompatibility evaluation, suggesting these are the key areas where the device's performance needs to be comparable to or better than the predicate.

Here's an analysis of the available information in the context of your request:

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

The document does not provide a table explicitly outlining acceptance criteria and reported device performance. It only states that "The results of the testing were used to address questions related to substantial equivalence based on difference in design between the Subject and Predicate Devices." and that "The performance testing results provided in this submission supports that the Subject Device performs as well as the Predicate Devices for its intended use."

The closest to "acceptance criteria" are the standards used for testing:

• Fatigue Performance: Modified version of ISO 14801 (in saline solution) to reflect clinical loading. The specific acceptance criteria (e.g., minimum fatigue limit, number of cycles) are not detailed. It only states that the fatigue limit was determined.
• Biocompatibility: ISO 10993-1:2018. Acceptance is implied by the statement "The results demonstrated that biocompatibility testing... is appropriate to assess the biological safety of the subject device." and "The results demonstrate the biocompatibility of the subject device."
• Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12. Acceptance is implied by "Validation for the cleaning and sterilization... was conducted."

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 explicitly stated for performance testing.
• Data Provenance: Not specified. It's likely from testing conducted by the manufacturer, Nobel Biocare AB (Sweden), or a contracted lab. The document does not specify if the data is retrospective or prospective.

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 the evaluation did not involve human interpretation or a "ground truth" derived from expert consensus in the sense of image analysis or diagnostic accuracy. The performance testing is engineering/laboratory-based.

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

This information is not applicable for the type of performance testing described. Adjudication methods are typically used in clinical studies or expert reviews.

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 as the device is a dental implant bridge, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm.

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

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

• Engineering standards: ISO 14801 for fatigue.
• Biocompatibility standards: ISO 10993-1.
• Sterilization standards: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
• The performance is compared to a predicate device rather than an absolute clinical "ground truth."

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as the device is a physical medical device.

Summary of what is available regarding the study:

The study described is a performance testing study aimed at demonstrating that the NobelProcera Zirconia Implant Bridge is substantially equivalent to a predicate device.

• Objective: To show that new technological characteristics (material Nacera Pearl, MUA Plus connection, DLC coating on prosthetic screw, maximum of 10 implants instead of 14) do not raise new concerns and that its performance is comparable to the predicate.
• Key Tests Conducted:
  • Fatigue testing: Using a modified version of ISO 14801 (in saline solution) to reflect clinical loading. "Worst-case assessment" was followed.
  • Biocompatibility evaluation: According to ISO 10993-1:2018, specifically cytotoxicity and chemical characterization using GC-MS analysis.
  • Sterilization validation: According to ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
• Comparison Basis: The subject device and predicate device were tested under identical conditions. The results "support that the Subject Device performs as well as the Predicate Devices for its intended use."
• Clinical Data: "No clinical data was used to support the decision of Substantial Equivalence."

In conclusion, the document provides evidence of engineering and biological performance testing against relevant standards and in comparison to a predicate device, rather than a study with explicit acceptance criteria for diagnostic accuracy or human performance improvement.

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TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.

TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models: W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment. The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved. The Subject Device includes the following dimensions: W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm. Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm. Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.

The provided document is a 510(k) Premarket Notification for the TAV Medical Ltd. W Zirconia Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth in the way one might evaluate a diagnostic AI system.

However, I can extract the information related to performance testing that supports the claim of substantial equivalence.

Here's an analysis of the "acceptance criteria" (which are more akin to performance benchmarks against predicate devices and regulatory standards in this context) and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implicitly meeting the performance of predicate devices and adherence to relevant ISO standards and FDA guidance documents. The document doesn't explicitly list numerical acceptance criteria with pass/fail thresholds in the same way a diagnostic AI study would. Instead, it states that the subject device's performance was "substantially equivalent" to the predicate devices and conformed to standards.

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

This document describes a medical device (dental implants), not an AI algorithm. Therefore, the concept of a "test set" for an AI model (like images with ground truth labels) does not directly apply.

• Mechanical Testing: While not explicitly stated as "sample size," mechanical tests (like fatigue testing and wear assessment) would involve a certain number of physical implant samples. This information is typically detailed in the full test reports, which are not included in this 510(k) summary. The summary only states that tests were performed according to ISO standards, which define methodologies including sample numbers.
• Data Provenance: Not applicable in the context of an AI test set. The provenance of the device components (materials, manufacturing) is Israel.

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

This is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert-established ground truth for a test set. Evaluation relies on established engineering principles, material science, and bio-compatibility standards through laboratory testing.

4. Adjudication Method for the Test Set

Not applicable for a physical medical device. Decisions are based on objective measurements 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 is not an AI diagnostic device.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

For a physical medical device, "ground truth" refers to established scientific and engineering principles, validated test methodologies, and regulatory standards.

• Material Properties: Conformance to ISO 13356:2015.
• Biocompatibility: Demonstrated through adherence to ISO 10993-1, 10993-5, and FDA guidance.
• Sterilization: Demonstrated through adherence to ANSI/AAMI/ISO 11137-2:2013 and ANSI/AAMI/ISO 17665-1:2006, and FDA guidance.
• Mechanical Performance: Demonstrated through adherence to FDA guidance (May 2004) and ISO 14801:2016. Testing involved objective measurements of fatigue life, wear, and screw loosening.

The underlying "ground truth" is that the device must meet the performance and safety requirements outlined in these standards and guidance documents, demonstrating substantial equivalence to legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

Not applicable as this is a physical medical device.

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