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Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.

The provided text is a 510(k) summary for a medical device (Straumann® BLX Gold Abutments) and does not describe an AI medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details for AI performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI system.

The document focuses on demonstrating substantial equivalence to predicate devices through material comparison, biocompatibility, sterilization validation, and bench testing for mechanical properties (dynamic fatigue, static strength, and loosening torque).

Here's an overview of the "acceptance criteria" and "study" information that is present, pertaining to a traditional medical device, not an AI one:

Acceptance Criteria and Reported Device Performance (as relevant for a traditional medical device)

Missing Information (as it pertains to an AI medical device, which this is not):

1. Sample sizes for test set and data provenance: No test set as described for an AI model.
2. Number of experts and qualifications to establish ground truth: Not applicable for this type of device.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Stand-alone (algorithm only) performance study: Not applicable.
6. Type of ground truth used: Not applicable.
7. Sample size for training set: Not applicable.
8. How ground truth for training set was established: Not applicable.

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Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.

This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.

However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.

Here's a breakdown of what is applicable from your prompt, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.

The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."

The substantial equivalence is primarily based on:

• Identical Indications for Use.
• Identical fundamental operating principles.
• Identical materials (Ti-6Al-7Nb titanium alloy).
• Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
• Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).

The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.

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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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