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CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

The system comprises three parts:

• CEREC Cercon 4D™ Abutment Block
• TiBase
• CAD/CAM system

The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.

CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.

The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.

Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.

Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set:
  • For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
  • For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
  • For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.

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

Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).

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-assisted diagnostic device; therefore, MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.

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

The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device does not have a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" in the context of machine learning.

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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing.

The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1.

All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.

This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).

Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.

This document is a 510(k) Premarket Notification from the FDA regarding the "Elos Accurate® Hybrid Base" dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information required to directly answer some of your questions, particularly those related to the performance study design for an AI/ML-based medical device (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models), is not present in this document. This is because the device in question is a physical dental implant component, not an AI/ML algorithm.

However, I can extract the relevant information regarding the performance data provided for this physical device.

Here's a breakdown based on the provided document:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML device submission would. Instead, it states that substantial equivalence is demonstrated through:

• Biocompatibility evaluation and confirmatory cytotoxicity testing: According to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Dynamic compression-bending testing: According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
• Engineering and dimensional analysis: To confirm compatibility with OEM implant bodies, OEM abutments, and OEM abutment fixation screws.
• Sterilization validation: In accordance with ISO 17665-1 and ISO 17665-2.

Reported Performance/Demonstration:

• "Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility."
• "Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants."
• "The coatings used on selected screws are identical to coatings on previously cleared devices."
• "Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2."
• "Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines... do not affect substantial equivalence. These minor differences... are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing."

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

• Sample Size: Not specified for any of the non-clinical tests (biocompatibility, dynamic fatigue, engineering analysis, sterilization). The document indicates "No clinical data were included in this submission," further confirming that there wasn't a "test set" in the context of patient data for AI performance evaluation.
• Data Provenance: Not applicable as it's not clinical data. The tests are laboratory-based.

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 device is a physical component, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.

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

• Not applicable. As above, this is not a diagnostic study requiring adjudication.

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. No clinical or human-in-the-loop study was conducted or required for this physical device.

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

• Not applicable. This is not an algorithm. The "performance data" refers to the physical and mechanical properties of the dental abutment.

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

• For the non-clinical performance data, the "ground truth" or reference standards are the ISO standards themselves (ISO 10993-5, ISO 14801, ISO 17665-1, ISO 17665-2), and the engineering specifications/dimensions of OEM implant components for compatibility analysis. This is a technical ground truth based on established material science and mechanical engineering principles, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this physical device.

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

• Not applicable. As above, no training set for an AI/ML model.

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The OsseoSpeed implants are intended to be used:

• to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
• for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
• for both one- and two-stage surgical procedures o
• especially well in soft bone applications where implants with other implant surface . treatments may be less effective
• together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
• together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
• with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.

The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

The provided text describes a 510(k) premarket notification for the Astra Tech Implant System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. Therefore, the "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood for a new therapeutic or diagnostic device (e.g., specific clinical endpoints, sensitivity/specificity thresholds) are not explicitly present in the document in the format requested.

Instead, the submission's goal is to show the new OsseoSpeed TX implants (with a narrower tapered apex design and modified drilling protocol for soft bone) are substantially equivalent to existing legally marketed devices. The "acceptance criteria" in this context would be the successful demonstration of this substantial equivalence, and the "study" is the comparison testing performed to support this claim.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations."

• Sample Size: The exact sample size for this comparative testing is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/non-clinical testing given the nature of comparing drilling protocols and bone-to-implant contact for implants.

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

This type of information (expert review for ground truth) is typically relevant for diagnostic devices interpreting medical images or data. For a dental implant's mechanical stability and bone-to-implant contact, the "ground truth" would be established through direct physical measurements, imaging, or histological analysis, rather than expert consensus on interpretation. Therefore, this information is not applicable and not provided in the document for an implant device.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the "testing" described involves comparing implant performance characteristics (mechanical stability, bone-to-implant contact) through presumably laboratory or animal studies, an adjudication method in this sense is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for comparing the performance of human readers, typically with and without AI assistance for diagnostic tasks. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one involving human interpretation of cases. Therefore, this type of study was not done and is not applicable.

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

No. This question is also relevant for diagnostic devices, specifically AI algorithms. The Astra Tech Implant System is a physical dental implant, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable.

7. The Type of Ground Truth Used

For the performance testing described ("compare OsseoSpeed TX implants... with OsseoSpeed implants... Calculations also were made to determine bone to implant contact"), the ground truth would be based on:

• Direct measurements/experiments: For primary mechanical stability and bone-to-implant contact, this would typically involve biomechanical testing (e.g., insertion torque, removal torque, pull-out strength tests) and potentially histological analysis or micro-CT imaging to quantify bone-to-implant contact in animal models or ex vivo samples.
• The document implies these were obtained through calculations and comparative testing, which points to direct experimental data rather than expert consensus, pathology (in the clinical sense for a patient), or outcomes data (long-term clinical results).

8. The Sample Size for the Training Set

This question is applicable to machine learning algorithms. Since the Astra Tech Implant System is a physical medical device (dental implant) and not an AI/ML algorithm, there is no training set and therefore no specified sample size for it.

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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The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

This 510(k) premarket notification for the Atlantis™ Abutment in Zirconia for Astra Implants does not include a study proving device performance against acceptance criteria in the way typically seen for diagnostic or AI-driven devices.

Instead, this submission is a claim of substantial equivalence to previously cleared predicate devices based on material, design, and intended use. The "acceptance criteria" here relate more to meeting established standards for biocompatibility and mechanical properties rather than performance in a clinical or diagnostic setting.

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on provided text)

Further Information Based on the Document:

1. Sample size used for the test set and the data provenance:

   • N/A. No "test set" in the context of performance data (e.g., clinical outcomes, diagnostic accuracy) is described. The submission relies on a comparison to predicate devices, material standards, and intended use.

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

   • N/A. No ground truth establishment by experts for a test set is described.

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

   • N/A. No adjudication method for a test set is described.

4. 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 abutment, not a diagnostic imaging device or an AI-driven tool for human readers. Therefore, an MRMC study is not applicable.

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

   • N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

   • N/A. For this type of 510(k) submission, the "ground truth" is largely established by adherence to recognized material standards (ISO, ASTM) and the established performance/safety profile of the predicate devices. There is no "ground truth" in the sense of clinical outcomes or pathology data specifically collected for this submission to prove its performance.

7. The sample size for the training set:

   • N/A. This is a physical medical device, not a machine learning model. There is no training set mentioned or implied.

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

   • N/A. As above, no training set is relevant here.

Summary of the Study/Evaluation described in the document:

The document describes a substantial equivalence claim rather than a "study" in the traditional sense of a clinical trial or performance evaluation against specific metrics. The "study" implicitly performed by the manufacturer, and reviewed by the FDA, involved:

• Comparison to Predicate Devices: The Atlantis™ Abutment in Zirconia for Astra Implants was compared to three predicate devices (K070833, K053384, K024111) to demonstrate equivalence in intended use, material, design, and performance. This is the primary method of evaluation for this 510(k)
• Material Characterization: The biocompatibility and composition of the materials (Y-TZP and Ti-6A1-V ELI) were likely verified against established international standards (ISO 6972, ISO 13356, ASTM F-136).
• Design Specifications: The design would have been reviewed to ensure it met specifications compatible with the Astra Tech OsseoSpeed™ implants and to verify that any design changes from predicate devices did not raise new questions of safety or effectiveness. This would include considerations for angled abutments and implant diameters.

The FDA's review and clearance signify their agreement that the provided information supports the claim of substantial equivalence, meaning the device is as safe and effective as the legally marketed predicate devices.

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Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm

• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text (K061478) is a 510(k) summary for a medical device called "Procera Titanium Abutment for AstraTech and Camlog Implant Systems." This document describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but no new questions of safety and effectiveness are raised. It does not generally involve a new clinical study with acceptance criteria in the same way an AI/ML device would.

Therefore, I cannot provide the requested information based on the provided text. The tables and study details you've asked for (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically associated with performance evaluations of AI/ML-driven devices, which this dental implant abutment is not.

The document essentially states that the device is similar in design, intended use, and operation to previously cleared abutments and is therefore substantially equivalent.

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Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm
• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• Ankylos 3.5, 4.5, 5.5, 7.0 mm

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm -
• -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• . Ankylos 3.5, 4.5, 5.5, 7.0 mm
  The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
  Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

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