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The NobelProcera Ti Abutments Camlog Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0 and 6.0 implants.

Nobel Biocare's NobelProcera Ti Abutment Camlog Platforms is an endosseous dental implant abutment. The abutment attaches directly to Camlog dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium.

The abutments are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants,

This document describes the NobelProcera Ti Abutment Camlog Platforms, a premanufactured prosthetic component for dental implants. The information provided focuses on the regulatory submission (510(k)) and its basis for demonstrating safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

The device is a direct comparator to a legally marketed predicate device (Nobel Biocare - NobelProcera Ti Abutment (K091756)). The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to the predicate, particularly concerning design, materials, and mechanical performance. The study conducted was non-clinical fatigue testing.

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

The document does not specify a "test set" in the context of human data or AI model evaluation. The study involved non-clinical performance of fatigue testing of the abutment. The sample size for this engineering testing is not explicitly stated but would typically involve multiple units to establish statistical confidence in the mechanical properties. The data provenance is non-clinical laboratory testing, not human data from a specific country.

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

This information is not applicable as the study was non-clinical fatigue testing, not a human reader study or clinical trial requiring ground truth established by medical experts.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation or a "test set" in the context of diagnostic performance that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on the substantial equivalence of a medical device (dental implant abutment) primarily through non-clinical mechanical testing, rather than evaluating the diagnostic or interpretative performance of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device (dental implant abutment), not an AI algorithm. Therefore, no standalone algorithm performance study was done.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through engineering standards and physical measurements from the fatigue testing, as dictated by the FDA guidance for endosseous dental implants and abutments. It is not an expert consensus, pathology, or outcomes data in the usual sense of clinical studies.

8. 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, not an AI model.

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The NobelProcera Ti Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Nobel Biocare's NobelProcera Ti Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

The provided text describes a 510(k) premarket notification for a dental implant abutment, not an AI device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from the given text. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (fatigue testing and analysis of platforms).

Here's an attempt to answer the questions based on the type of information that would be relevant if it were an AI device, but highlighting that this specific document does not contain that information:

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 for Test Set: Not applicable. The testing was non-clinical and involved "analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples." No patient data or test set in the context of AI or diagnostic performance was used.
• Data Provenance: Not applicable. No patient data or images were used.

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. As no patient data or diagnostic interpretations were involved, there was no need for experts to establish ground truth in this context. The "truth" in this case is the mechanical integrity and performance as measured through engineering tests.

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

• Not applicable. There was no test set requiring human adjudication as this was non-clinical mechanical 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 study did not involve human readers or AI assistance.

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

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

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

• The "ground truth" for this device's performance was established through engineering standards and physical testing. Specifically, fatigue testing was performed "in accordance with the FDA quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance document would define the acceptable mechanical properties and performance thresholds.

8. The sample size for the training set

• Not applicable. This device is a manufactured medical component, not an AI model that requires a training set.

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

• Not applicable. No training set was used.

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The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's NobelProcera Ti Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Ti Abutment attaches directly to endosseous dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

The provided text is a 510(k) summary for the NobelProcera Ti Abutment. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study or performance testing that would typically generate the kind of data requested in the prompt.

The document discusses device description, indications for use, and a comparison with legally marketed predicate devices to establish substantial equivalence. It does not contain information on acceptance criteria for device performance, nor does it detail a study performed to meet such criteria. Therefore, most of the requested fields cannot be extracted from this document.

Here's a breakdown of what can be extracted and what information is missing:

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

• Missing. The document does not specify any acceptance criteria for device performance or provide reported performance metrics. The 510(k) process for this type of device (dental implant abutment) relies on demonstrating substantial equivalence to previously cleared devices, often through mechanical testing, biocompatibility, and material equivalence, rather than clinical performance metrics found in the prompt's context (like sensitivity, specificity, or reader improvement with AI).

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

• Missing. No test set or study data of this nature is mentioned.

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

• Missing. This information is relevant for studies involving human interpretation or expert-driven evaluations, which are not detailed here.

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

• Missing. Similar to the above, this would be relevant for expert-based evaluations, which are not described.

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:

• Missing. This type of study (MRMC, AI assistance) is not applicable to an endosseous dental implant abutment and is not mentioned in the document.

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

• Missing. Not applicable to this device type.

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

• Missing. No "ground truth" as typically defined in diagnostic performance studies is applicable or mentioned. The device's safety and effectiveness are established through reference to predicate devices and material/design specifications.

8. The sample size for the training set:

• Missing. No training set for an algorithm is mentioned.

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

• Missing. Not applicable.

Summary based on the provided document:

The provided 510(k) summary for the NobelProcera Ti Abutment focuses on demonstrating substantial equivalence to predicate devices already on the market. It confirms the device's indications for use and its material composition. The document does not contain any information about acceptance criteria or performance studies (like those involving AI, human readers, or diagnostic metrics) as typically discussed for software as a medical device or diagnostic imaging devices. The type of information requested (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies) is not usually found in a 510(k) for a mechanical dental prosthetic component like an abutment.

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