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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 cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS™ Abutment to the endosseous implant.

The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS™ Crown Abutment to the endosseous implant.

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATLANTIS™ Abutment for NobelActive 3.0.

Important Note: The provided document is a 510(k) premarket notification for a medical device (dental implant abutment). These types of submissions typically focus on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance criteria or conducting extensive effectiveness studies for a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this type of traditional medical device submission.

The "studies" described are primarily non-clinical engineering tests to ensure mechanical integrity and compatibility with the predicate device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the summary. For mechanical testing (ISO 14801), devices are typically tested in small batches to statistical significance or to demonstrate compliance with a specific load rating. The exact number of abutments tested is not provided.
• Data Provenance: The "Non-Clinical Performance Data" section (Section 7) describes testing performed by DENTSPLY International, Inc., the manufacturer/submitter, and references predicate devices. This would be considered prospective testing conducted specifically for this 510(k) submission or in support of prior predicate device approvals. The country of origin of the data is implied to be within the company's testing facilities, likely in the US as the submitter is a US company.

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

• N/A. This device is a physical medical device (dental abutment), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" for its performance is established through quantitative mechanical testing and engineering analyses against defined standards (like ISO 14801).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are relevant for human evaluation processes, especially in clinical trials or AI performance evaluations involving multiple readers. This is a physical device undergoing mechanical and engineering tests, not an interpretive task.

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

• N/A. This is not an AI-powered diagnostic or assistive device. It is a physical dental implant abutment.

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

• N/A. This is a physical dental implant abutment, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Strength & Compatibility: The "ground truth" is defined by engineering standards and specifications (e.g., ISO 14801, material properties, dimensional tolerances, fit with the corresponding implant). Performance is measured against these objective standards.
• For Biocompatibility & Sterility: The "ground truth" is derived from established regulatory standards and validated testing protocols (e.g., ISO 10993 for biocompatibility, ISO 11137 or AAMI standards for sterility assurance levels).

8. The Sample Size for the Training Set

• N/A. This is not an AI algorithm that requires a training set. The design of the ATLANTIS™ Abutment is based on CAD/CAM technology, but the "training" in this context refers to the manufacturing process, not machine learning.

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

• N/A. As there is no AI training set, this question is not applicable. The design and manufacturing process for the CAD/CAM abutment are governed by engineering principles and quality control, not ground truth derived from annotated data.

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NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.

Here's an analysis of the acceptance criteria and supporting studies for the NobelActive® dental implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with clear thresholds for success (e.g., "must achieve X% success rate"). Instead, it describes performance benchmarks relative to existing devices and clinical expectations for dental implants.

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

• Bench Studies:

  • Drilling protocols: 1 implant (4.3x13 mm) tested in each of two bone surrogate types.
  • Primary stability and micro-motion: Not explicitly stated, but "different implant geometries and simulated bone densities" were used with "comparator devices." The number of implants per geometry/density is not provided.
  • Provenance: Not explicitly stated, but these are non-clinical (laboratory) studies.

• Clinical Studies:

  • Study 1 (Healed Sites): 199 NobelActive® implants.
  • Study 2 (Extraction Sites): 137 NobelActive® implants.
  • Study 3 (Implant Handling): 88 implants.
  • Study 4 (Irinakis and Wiebe, 2009): 140 implants.
  • Study 5 (Demanet et al, 2011): 466 implants.
  • Data Provenance: The document does not explicitly state the country of origin. Clinical studies are inherently prospective to some extent, but the reporting here is retrospective (summarizing past studies). The "Irinakis and Wiebe (2009) conducted a prospective study" explicitly states it was prospective. The other clinical data descriptions imply retrospective analysis of existing clinical data.

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

• Bench Studies: Ground truth is based on physical measurements and engineering principles. Experts (engineers, researchers) are involved in conducting and interpreting these tests, but their specific number or dental qualifications are not specified as they relate to the "ground truth" of implant performance in a lab setting.
• Clinical Studies:
  • Bone quality classification (Lekholm and Zarb) was done "by the treating surgeon" according to standard methods, including imaging, pre-surgical investigation, and tactile sensation.
  • "Four (4) clinicians" placed implants in the implant handling study.
  • The studies mentioned clinical investigators/treating surgeons for implant placement and follow-up. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. However, a "treating surgeon" or "clinician" implies medical/dental professionals experienced in implantology.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or data interpretation. Clinical results are typically derived from direct observation and measurement on patients, with success/failure criteria defined within each study's protocol.

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 document is for a dental implant (a physical device), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.

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

As noted above, this submission is for a physical medical device (dental implant). It does not involve an algorithm or AI, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Studies: Physical measurements (torque, micro-motion, seating depth) in simulated environments (bone surrogates).
• Clinical Studies:
  • Clinical outcomes: Implant success/failure rates, survival rates, insertion torque values, bone quality classification by the treating surgeon. This is essentially direct clinical observation and measurement of "real-world" performance in patients.

8. The Sample Size for the Training Set

This submission pertains to a physical dental implant, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/algorithms is not applicable. The clinical data described contributes to the overall evidence base for the device's performance, rather than serving as a training set for an algorithm.

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

Since this is not an AI/ML device, there is no "training set" and thus no ground truth established for one. The clinical studies mentioned contribute to demonstrating the device's safety and effectiveness for its intended use.

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Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.

Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.

The provided text describes a 510(k) submission for the Nobel Biocare NobelActive Wide Platform (WP) implant, seeking substantial equivalence to predicate devices. The submission focuses on technological characteristics and MR conditional testing, and explicitly states that no clinical data was necessary. As such, the requested information regarding acceptance criteria, study details, and ground truth establishment for an AI/algorithm-based device is not applicable to this submission.

Therefore, many of the requested fields cannot be filled.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. The submission explicitly states, "Nobel Biocare utilizes an ISO 14971 Risk Management System. The NobelActive Wide Platform (WP) was subjected to this system which determined that no clinical test data was necessary to support the decision of safety and effectiveness excluding the MRI Safety and compatibility."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test data was necessary.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test data was necessary.
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: Not applicable. This is not an AI/algorithm-based device, and no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical test data was necessary. The determination of substantial equivalence was based on technological characteristics and MR conditional testing results.
7. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device and no training set was used.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm-based device.

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The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or Regular Platform (RP) Ø 3.9mm

The Zimmer Zfx Titanium Abutment for the NobelActive Implant system is designed for use with NobelActive and NobelReplace Conical Connection endosseous dental implants to support single or multi tooth restorations. The abutment/implant interface is an internal conical connection with a hexagonal interlock.

The Zimmer Zfx Titanium Abutment for NobelActive Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and is secured to the implant with a separate Titanium alloy screw for retention.

The new abutments will all be available with a choice of 3.5mm and 3.9mm implant platform diameters.

This is a premarket notification for a dental abutment, a mechanical component, not an AI/ML device, therefore, the requested information regarding acceptance criteria and studies are not applicable in the context of AI/ML.

Here's why and what information is available about the non-clinical testing:

Device Type: The device is a "Zimmer Zfx Titanium Abutment for NobelActive Implant System," which is an endosseous dental implant abutment. This is a physical, mechanical medical device.

Absence of AI/ML Specifics: The document describes the materials, design, indications for use, and non-clinical testing (mechanical and compatibility) for this physical component. There is no mention of artificial intelligence, machine learning, or any software-based diagnostic or predictive capabilities. Therefore, criteria such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML (e.g., sensitivity, specificity, AUC) are not relevant here.

However, I can extract information related to the non-clinical testing performed to determine substantial equivalence as described in the document:

The non-clinical testing aimed to support the decision of substantial equivalence to predicate devices, focusing on fit, function, and safety of the mechanical component.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to non-clinical testing for a mechanical device):

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

• Mechanical Fatigue Testing: The document states "fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants." No specific sample size (N) for the number of abutments or implants tested is provided in this summary.
• Data Provenance: The testing was conducted by Zimmer Dental Inc. in support of their 510(k) submission. It is internal testing performed by the manufacturer. It is retrospective in the sense that it was done to support a pre-market submission, not ongoing clinical data collection.
• MRI Compatibility: Implied to be laboratory testing rather than patient data.

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

• Not applicable as this is a mechanical device evaluation, not an expert-driven diagnostic assessment. Ground truth is based on engineering specifications and physical test results against established standards.

4. Adjudication method for the test set:

• Not applicable for a mechanical device. The "adjudication" is through physical testing results and engineering analysis.

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 not an AI/ML diagnostic tool and thus does not involve "human readers" or "AI assistance."

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• Compatibility & Dimensional Fit: Engineering drawings, physical measurements of predicate devices, and established dimensional tolerances.
• Mechanical Fatigue Testing: Industry standards (FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments) and performance data from legally marketed predicate devices.
• Sterilization: Regulatory standards for Sterility Assurance Level (SAL) of 10^-6.
• MRI Compatibility: FDA guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set. The "design input" could be considered analogous, which would include the engineering specifications and reverse-engineered dimensions from predicate devices.

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

• Not applicable. No training set is used for this type of device. The design specifications were derived from reverse engineering existing compatible systems and industry standards.

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The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.

The provided text describes a 510(k) submission for a dental abutment. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or standalone performance studies with specific acceptance criteria as you've outlined for AI/software devices.

Therefore, many of the requested categories (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this document. The "device performance" in this context refers to non-clinical fatigue testing to ensure the device's mechanical strength is adequate and comparable to predicates.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for a traditional AI/software device evaluation:

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

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: Not specified. This typically refers to the number of physical abutments subjected to fatigue testing.
• Data Provenance: Not applicable in the context of clinical data for this type of device. The testing is non-clinical/mechanical.

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 is a non-clinical, mechanical device. "Ground truth" would refer to the physical properties and performance measured during fatigue testing, not expert interpretation.

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

• Not Applicable. This is a non-clinical, mechanical device. Adjudication methods are typically used for expert review of clinical cases.

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. The document explicitly states: "No clinical testing was performed." MRMC studies apply to AI-assisted diagnostic tools involving human readers.

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

• Not Applicable. This is a physical, non-AI dental abutment.

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

• Not Applicable. The "ground truth" for this device's performance is determined by the physical results of fatigue testing, measured against established engineering standards (e.g., ability to withstand anticipated forces, as outlined in FDA guidance for dental implants).

8. The sample size for the training set

• Not Applicable. This is a non-AI, physical medical device. There is no training set as would be found in machine learning.

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

• Not Applicable. This is a non-AI, physical medical device. There is no training set or ground truth establishment relevant to AI/software development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets its (implicit) acceptance criteria is a non-clinical fatigue testing study.

• Methodology: The testing was conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance outlines the specific mechanical tests and acceptance criteria for demonstrating the durability and strength of such devices.
• Results: The testing indicated "that the device is strong enough to withstand the anticipated forces."
• Conclusion: Based on this non-clinical data, the device was deemed "substantially equivalent" to predicate devices, satisfying the requirements for 510(k) clearance by demonstrating comparable safety and effectiveness, particularly in terms of mechanical integrity.

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The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

The NobelActive 3.0 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of titanium vanadium alloy.

The provided text describes a 510(k) premarket notification for the NobelActive 3.0 Angled Abutment. This submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not involve a study of an AI/ML powered medical device with acceptance criteria in the traditional sense of evaluating algorithmic performance.

Here's an analysis of why the requested information cannot be fully provided based on the given text, followed by the information that can be extracted:

• No AI/ML Component: The device described is a dental implant abutment, a physical medical device made of titanium vanadium alloy. There is no mention of any artificial intelligence or machine learning component.
• No "Acceptance Criteria" for Algorithmic Performance: The "acceptance criteria" here refer to satisfying the requirements of the FDA guidance for dental implants/abutments, specifically fatigue testing. These are not performance metrics for an algorithm (e.g., sensitivity, specificity).
• No "Study that proves the device meets the acceptance criteria" in terms of algorithmic performance: The "study" mentioned is non-clinical fatigue testing, not a clinical or standalone study of an algorithm.
• No Ground Truth, Experts, or Adjudication for Algorithms: These concepts are entirely irrelevant to a physical dental device.

Information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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 for Test Set: Not explicitly stated. The document mentions "non-clinical testing consisted of performance of fatigue testing," but does not provide details on the number of samples tested.
• Data Provenance: Not applicable in the context of device performance data location; it's a non-clinical, laboratory-based test.

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 relates to interpretation of data for ground truth establishment. For a physical device, performance is typically measured through engineering tests, not expert interpretation of data.

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

• Not applicable. No expert adjudication process is described for non-clinical fatigue testing.

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 is a physical dental device, not an AI/ML powered device, so no MRMC study with AI assistance was performed.

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

• No. This is a physical dental device, not an algorithm.

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

• Not applicable. For this type of device, "ground truth" would be the measured physical properties and performance characteristics against established engineering standards and safety requirements. The "ground truth" for meeting acceptance criteria is the successful completion of the fatigue testing described in the FDA guidance document.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned or relevant.

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

• Not applicable. No training set or associated ground truth establishment is mentioned or relevant.

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Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive 8.5 mm & 18.0 mm implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

NobelActive Internal Connection Implants are similar to predicate NobelActive Internal Connection Implants. The NobelActive 8.5 mm and 18.0 mm implants differ from the predicate device in length.

This document describes the NobelActive 8.5 mm & 18.0 mm dental implants and their substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) summary for a dental implant, which is a physical medical device. It focuses on device description, indications for use, and a demonstration of substantial equivalence to an existing predicate device based on differences in length for the new models.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided documentation for this type of medical device submission.

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NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

The NobelActive GoldAdapt Abutment is an endosseous dental implant abutment intended to be used with the NobelActive implant system. The NobelActive GoldAdapt is made of gold alloy and comes in engaging and non-engaging styles.

NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

The provided text is a 510(k) summary for the NobelActive GoldAdapt Abutment and NobelActive Internal Connection Implant. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance as would be found for a novel device or AI/software as a medical device (SaMD).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the core of a 510(k) submission for this type of device (dental implant components). The studies typically performed for such devices are focused on mechanical strength, biocompatibility, and fit, often by comparing them to the predicate devices or established standards, rather than clinical performance metrics in the way a diagnostic AI would be evaluated.

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NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.

NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.

This document is a 510(k) summary for a dental abutment, which is a physical device, not an AI/ML algorithm. Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI performance are not applicable.

The document describes the NobelActive Zirconia Abutment, a pre-manufactured prosthetic component intended for use in dental rehabilitation.

Here's the relevant information from the provided text, re-contextualized for a physical medical device:

Device Description:

• Device Name: NobelActive Zirconia Abutment
• Purpose: Artificial tooth abutment designed to fit and function on NobelActive Implants.
• Design: Internal hexagonal design, similar to previous SFB (renamed NobelActive) Abutments.
• Material: Same as previous Esthetic Zirconia Abutments.
• Distinguishing Features (from predicate): Differs in trade name and material of construction from the predicate device.

Indications for Use:

• "NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region."

Regulatory Information:

• 510(k) Number: K072129
• Applicant: Nobel Biocare USA LLC
• Predicate Devices: SFB & CFB Angled Abutments (K062749) and Esthetic Zirconia Abutment (K031719)
• Classification: Class II, Endosseous Dental Implant Abutment (21 CFR 872.3630)

Study Information (as pertains to a physical device submission):

For physical medical devices like this, the "study" typically refers to demonstrating substantial equivalence to a predicate device through material characterization, mechanical testing, and biocompatibility assessments, rather than clinical performance studies with large patient cohorts and complex statistical analyses as would be common for new drugs or AI algorithms. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The provided text does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested for AI/ML algorithms (i.e., performance metrics, sample sizes for test/training, ground truth, expert opinions, etc.). Instead, the FDA's acceptance is based on the demonstration of substantial equivalence to existing predicate devices.

The submission would have included:

• Comparison to Predicate: A comparison of the new device's technological characteristics (design, materials, indications for use) to the predicate devices.
• Performance Data: This would typically include bench testing for mechanical properties (e.g., strength, fatigue, torque, fracture resistance) of the abutment and its connection to the implant, material characterization (e.g., chemical composition, microstructure), and possibly biocompatibility data. This data would be compared against established standards or performance levels of the predicate devices.
• No "acceptance criteria table" or "reported device performance" in the AI/ML sense is present. The "performance" is implicitly deemed acceptable if it meets the criteria for substantial equivalence, ensuring it performs as intended and is as safe and effective as the predicates.

Without further documentation (e.g., the full 510(k) submission, which would detail the specific tests and their results), it's impossible to provide the granular "acceptance criteria" and "study data" in the AI/ML context.

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NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Multi Unit Abulments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous SFB Abutments. The NobelActive Multi Unit Abutments differ from the predicate device in trade name and design.

This document is a 510(k) summary for the NobelActive Multi Unit Abutment. It is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance in the context of a study, nor does it present the results of a study to demonstrate such performance or discuss any AI components.

The document focuses on:

• Legal Information: Submission details, classification names, trade names, and legally marketed predicate devices.
• Device Description: Material and design differences/similarities to predicate devices.
• Indications for Use: The intended purpose of the device (prosthetic rehabilitation).
• FDA Correspondence: Official letter from the FDA determining substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert information, MRMC studies, or standalone algorithm performance) from the provided text. This type of information is typically found in clinical trial reports, validation studies, or performance testing summaries, which are not part of this 510(k) summary.

Ask a specific question about this device