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The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Overdenture Bars are computer aided design (CAM) precision milled, individually designed Superstructures manufactured for each patient. The NobelProcera Overdenture Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite or porcelain veneer.

The Superstructures can be either Fixed Shaped Bars such as Dolder, Hader, Round, or Free Form Shaped Bars such as Free Form Milled, Montreal, Paris, Wrap-around; or a combination of shapes. The Overdenture Bar shapes and design parameters remain unchanged from the predicate device, Procera Implant Bridge Overdenture (K090069). Additionally, the Superstructure can also be designed per specific prescription order by qualified health care professionals.

The Superstructure is a multiple unit restoration for fixed or removeable dental prosthetic framework milled from one solid piece of material. The NobelProcera Overdenture Bar accommodates commercially available denture attachments for removable dental prosthesis, or retention elements for fixed dental prosthesis.

The many abutment and implant interfaces that can be used in the Superstructure are precision milled and are an integral part of the Overdenture Bar.

The NobelProcera Overdenture Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the NobelProcera Overdenture Bar is matched to a denture for final placement.

The provided text describes a 510(k) summary for the NobelProcera Overdenture Bar, which is a dental device. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, Procera® Implant Bridge Overdenture (K090069), and to expand the list of compatible implant and abutment interfaces. The information provided focuses on the device's design, materials, manufacturing, intended use, and a comparison with the predicate device, along with the results of non-clinical testing.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The "test set" for demonstrating safety and effectiveness of additional implant and abutment interfaces was a retrospective study of NobelProcera Overdenture Bars placed in the market globally since 2010.
• Sample Size: The exact number of overdenture bars or patients included in this retrospective study is not specified in the provided text.
• Data Provenance:
  • Country of Origin: Globally since 2010.
  • Retrospective or Prospective: Retrospective.

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

The document does not mention the use of experts to establish ground truth for the retrospective study on compatible interfaces. The "data set of compatible implant and abutment interfaces were generated through measurements of original manufacturer's bar interfaces." This implies engineering measurements and specification comparisons, rather than clinical expert consensus on outcomes.

4. Adjudication Method for the Test Set

Not applicable. The study described is based on measurements and a retrospective review of market performance, not on a clinical assessment by experts requiring adjudication.

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

No. The provided text does not describe an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a physical dental overdenture bar, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical product, not an algorithm, and thus does not have a "standalone" or "human-in-the-loop" performance as typically understood for AI/software devices. The "algorithm" aspect refers to the CAD/CAM manufacturing process, which is inherent to creating the physical device.

7. Type of Ground Truth Used

• For the additional implant and abutment interfaces: Measurements of original manufacturer's bar interfaces. This refers to engineering specifications and compatibility checks.
• For overall safety and effectiveness: The retrospective study implicitly relies on real-world performance data of the device in the market, although the specific metrics or "ground truth" for assessing this performance retrospectively are not detailed (e.g., lack of reported failures, successful chewing function, etc.).
• For fatigue and MR safety: Standards compliance and non-clinical test results were used as ground truth.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device manufactured via CAD/CAM, there isn't a "training set" in the context of machine learning algorithms. The design parameters are based on established dental anatomy, engineering principles, and the specific interfaces of compatible implants/abutments.

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

Not applicable, as there is no "training set" in the context of AI/machine learning. The design and manufacturing process relies on:

• Clinical and engineering specifications: Defining the various bar shapes (Dolder, Hader, Round, etc.) and their dimensions.
• Compatibility standards: Ensuring precision milling to fit specific implant and abutment interfaces.
• Established dental principles: For restoring chewing function in edentulous jaws.

The "ground truth" for the manufacturing process would be the accurate replication of the patient-specific design within specified tolerances, which is verified through quality control and fit checks against the master cast.

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