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The Strauman® PURE Ceramic Implant 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 (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.

This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.

The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.

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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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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 Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.

Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.

The Straumann® PURE Ceramic Implant (Monotype) is made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness to support osseointegration (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 (Monotype) 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.

The Protective Caps are manufactured from polyetheretherketone (PEEK Classix).

The temporary copings are manufactured from polymethylmethacrylate (PMMA).

This document is a 510(k) premarket notification from the FDA, approving the Straumann® PURE Ceramic Implants. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe a study that validates the device against acceptance criteria in the way a clinical trial or performance study for an AI/diagnostic device would.

The "acceptance criteria" mentioned in the document refers to the success rate of the implant in a clinical study, which is a different type of acceptance criteria than what would be presented for an AI device.

Let's break down what information is available based on your request and what is not available for a device like this.

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

For an AI/diagnostic device, acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, etc., compared against predefined thresholds. For this dental implant, the primary "acceptance criterion" mentioned is the clinical success rate.

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 (Clinical Study): 41 ITT (Intent-To-Treat) patients with complete follow-up through two years.
• Data Provenance: Not explicitly stated in terms of country of origin. The study appears to be a prospective clinical follow-up as it refers to patients' survival to at least two years.

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 to this type of device and study. For an implant, "ground truth" would be the patient's clinical outcome (survival, successful integration, etc.), not an expert's interpretation of an image or a condition.

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

This section is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates disagreement) are used for diagnostic interpretations, not for direct clinical outcomes of an implant. The outcomes (survival) are directly observed.

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 section is not applicable. This is not an AI or diagnostic device, so there is no concept of human readers or AI assistance.

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

This section is not applicable. This is not an AI algorithm.

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

• Type of Ground Truth: Outcomes data (specifically, implant survival/success at two years).

8. The sample size for the training set

This section is not applicable. This is not a machine learning or AI device that requires a training set. The clinical study investigated the implant's performance directly.

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

This section is not applicable for the same reason as point 8.

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