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The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The On1 Universal Abutment is a dental implant abutment which attaches to the On1 Base of the On1 Concept (K161655) and is intended to be used with the current Nobel Biocare dental implants that have the existing internal conical connection.

The On1 Universal Abutment features a fixed upper shape with indexing feature that is intended to serve as the platform for either an in-laboratory CAD/CAM system made mesostructure or abutment crown. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.

The On1 Universal Abutment is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for the internal conical connection. The On1 Universal Abutment is made of titanium vanadium alloy.

The document does not detail specific acceptance criteria or a dedicated study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with defined endpoints. Instead, it describes a 510(k) summary for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is a series of non-clinical performance tests designed to show that the On1 Universal Abutment performs comparably to its predicate and reference devices, and that any differences do not raise new questions of safety or effectiveness.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly state "acceptance criteria" for performance in a table format. However, it does list "Restorative design specifications" which act as internal design criteria, and various performance tests that the device successfully met. The key "acceptance criterion" implied throughout the document is "substantial equivalence" to the predicate devices.

• Compliance with minimum required fatigue properties per ISO 14801.
• Restorative design specifications:
  • Angle from axis of the implant: 20° Max
  • Wall Thickness Circular: 0.8mm min.
  • Wall Thickness Margin: 0.275mm min.
  • Post Height: 5.2mm min.
  • Maximum Length, width and Height: EM-14 blank 12x14x18mm, EM-10 blank 8x10x15mm | Mechanical Performance:
• "Worst case dynamic fatigue testing per ISO 14801 demonstrating compliance with the minimum required fatigue properties of the On1 Universal Abutment with a bonded Enamic mesostructure. Results confirmed that the proposed On1 Universal Abutments were equivalent to the predicate devices."
• Device design adheres to the listed restorative design specifications. |
  | Biocompatibility:
• Compliance with ISO 10993-1, ISO 10993-5 (Cytotoxicity), CEN EN ISO 10993-12, and CEN EN ISO 10993-18 (GC-MS analysis for organic leachables/extractables). | Biocompatibility:
• "Biological evaluation was conducted according to ISO 10993-1. Cytotoxicity testing per ISO 10993-5 was conducted on the finished devices. GC-MS analysis was performed... Results indicate that the devices met biocompatibility requirements for its intended use." |
  | Software Verification and Validation:
• Restrictions prevent design of mesostructure component outside of design limitations.
• Established design limitations and specifications are locked and cannot be modified within the abutment design library. | Software Verification and Validation:
• "Validation was completed on the On1 Universal Abutment with the 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORiTEC imes-icore milling unit workflow. Software verification and validation testing was provided for the subject abutment design library to demonstrate use with the 3Shape Abutment DesignerTM Software (K151455). ...testing was conducted to demonstrate that the restrictions prevent design of the mesostructure component outside of design limitations... In addition, the encrypted abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library." |
  | Sterilization Validation:
• Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2 for steam sterilization. | Sterilization Validation:
• "Steam sterilization analysis was performed following AAMI-TIR30, ISO 17665-1, and ISO 17665-2." |
  | Device Packaging:
• No new worst-case in terms of device packaging and shelf life compared to predicate. | Device Packaging:
• "The packaging for the subject device is the same as the predicate. This is a thermoform tray with peel top lid. Therefore, no additional testing was required." |

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: The document does not specify the exact sample sizes for the mechanical, biocompatibility, software, or sterilization testing. It refers to "worst case dynamic fatigue testing" and "the finished devices" for biocompatibility without providing numbers.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from Nobel Biocare AB (Sweden) and Nobel Biocare USA LLC (USA), it's likely the testing was conducted in facilities accustomed to international and US regulatory standards, but specific locations are not mentioned. The nature of the tests (mechanical, biocompatibility, software, sterilization) suggests controlled laboratory experiments, not patient data.

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)

This section is not applicable as the document describes non-clinical performance testing for a dental implant abutment, not a diagnostic or screening device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established international standards (e.g., ISO 14801, ISO 10993 series).

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

This is not applicable for the type of non-clinical performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving reader interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth for a test set. The tests here are objective engineering and material science evaluations.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance, often in diagnostic tasks, and is not relevant for a dental implant abutment. The device is a physical component, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical dental implant abutment, not an algorithm or AI system. Software verification and validation were performed for the accompanying design software, but this is distinct from "standalone algorithm performance" in the context of AI.

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

The "ground truth" for the performance testing described are established international standards and specifications (e.g., ISO 14801 for dynamic fatigue, ISO 10993 series for biocompatibility, AAMI-TIR30, ISO 17665-1/2 for sterilization). For software, the ground truth is the predefined design limitations and specifications that the software must enforce and protect.

8. The sample size for the training set

This is not applicable. The device is a physical component, not an AI model that requires a training set. The descriptions of "design workflow" and "manufacturing workflow" refer to the process by which the abutment is designed and fabricated, not machine learning model training.

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

This is not applicable as there is no training set for an AI model.

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