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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra 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. Nobel Active Tilltra 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 TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental 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. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

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This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.

This document is a 510(k) Pre-market Notification for the Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System. It is an older document from 1997, and the information provided is typical for devices seeking substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable or present in this document.

The core of this submission is a comparison of technological characteristics to predicate devices to establish substantial equivalence.

Here's an attempt to fill in the table and address the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance Study Summary (K970499)

This 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices. Performance acceptance criteria for a "new" device, as would be expected for an AI/ML device, are not explicitly defined or tested in the way typically required today. Instead, the "acceptance criteria" here implicitly revolve around demonstrating that the new device's components are technologically identical to the predicate components and serve the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device. The "test" here is the comparison of technological characteristics to predicate devices.
• Data Provenance: Not applicable. No clinical or dataset-based performance data is presented.

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

• Number of Experts: Not applicable. No "ground truth" was established for a test set as would be done for an AI/ML device. The "ground truth" for this submission is essentially the understanding of the design and materials of the predicate devices.
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was 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

• MRMC Study: No. This is not an AI-assisted device.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

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

• Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for this 510(k) is the established technological characteristics and intended uses of the predicate devices.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device.

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

• Ground Truth for Training Set Establishment: Not applicable.

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