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The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

In this submission, the device is the Straumann® PURE Ceramic Implants. This documentation discusses a 510(k) premarket notification for a change in the sterilization method of an existing device, rather than the initial introduction of a novel AI/software device. As such, the presented information does not align with the typical structure of an AI/software device study and acceptance criteria as outlined in your request. The core of this submission revolves around demonstrating that a change in sterilization from H₂O₂ plasma to Ethylene Oxide (EO) for a dental implant does not negatively impact its safety and effectiveness.

Therefore, many of the requested categories, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Effect size of human readers improvement with AI vs without AI," "Stand-alone algorithm performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to address the change in sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly linked to maintaining the same performance and safety profile as the predicate device despite the change in sterilization method. The "reported device performance" refers to the results of the tests conducted to confirm this.

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

• The document does not specify exact sample sizes for each test (e.g., how many implants were tested for mechanical strength, how many packages for transportation studies, etc.). It refers to "subject devices" and "worst-case environmental and handling changes."
• Data Provenance: The studies were conducted by the manufacturer (Straumann USA, LLC on behalf of Institut Straumann AG), and the data are part of a regulatory submission to the FDA for a device to be marketed in the US. The provenance is therefore related to the manufacturer's internal testing. It is retrospective in the sense that the studies were performed prior to the submission; they are not drawn from real-world patient data (prospective or retrospective) in the context of device performance in humans.

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

• This concept is not directly applicable here. The "ground truth" for these tests is defined by established international standards (ISO 11135, ISTA 2A, ASTM F1980, ISO 10993-1, ISO 14801) and FDA guidance documents. The "experts" are the engineers, scientists, and technicians who designed and executed these tests and interpreted the results according to these predefined standards. Their qualifications would align with expertise in sterilization validation, biocompatibility, mechanical engineering, and quality assurance for medical devices. Specific numbers and qualifications of individual experts are not provided in this type of summary.

4. Adjudication Method for the Test Set:

• Not applicable in the context of expert review of images or data. Adjudication in this context relates to how the test results are evaluated against the relevant standards and how compliance is determined. This is typically done through interpretation by the conducting laboratory/personnel and reviewed by regulatory affairs, quality assurance, and potentially notified bodies or the FDA, based on the pass/fail criteria outlined in the standards.

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:

• Not applicable. This submission is not about an AI/software device or its impact on human reader performance.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" is based on established international standards and regulatory guidance documents for medical device performance and safety. For example:
  • Sterility: ISO 11135 (Sterility Assurance Level of 10⁻⁶)
  • Biocompatibility: ISO 10993-1 (Pass/fail criteria for cytotoxicity, residue levels)
  • Mechanical Strength: ISO 14801 (defined load limits and fatigue cycles)
  • Packaging: ISTA 2A, ASTM F1980 (criteria for package integrity and shelf life)
• The ground truth is not derived from expert consensus on clinical cases, pathology, or outcomes data in the usual sense of an AI study. Instead, it's about meeting pre-defined scientific and engineering benchmarks.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. No training set exists for this type of device submission.

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