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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

Summary of what is available regarding the study:

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

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

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

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