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Thommen Milling abutments for CAD/CAM are intended to be used in conjunction with Thommen System dental implants in the maxillary and /or mandibular arch to provide support for crowns, bridges and overdentures.

All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture.

The Milling Abutment for CAD/CAM is an abutment used by a dental laboratory equipped with the 3Shape CAD/CAM System to fabricate a customized abutment made of titanium. Each patient-specific abutment is individually prescribed by the clinician. Minimum wall thickness allowed for the final abutment is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height of the abutment is no greater than 15 mm and no shorter than 4.5 mm. All digitally designed abutments for use with Thommen Milling abutments for CAD/CAM are intended to be sent to a Thommen validated milling center for manufacture. Final abutments are to be sterilized prior to intraoral placement.

Milling Abutment for CAD/CAM is available in five diameters (3,5 mm, 4,0 mm, 5,0 mm, 6,0 mm) and two heights (12 mm and 15 mm). The Ø3.5 mm abutment is provided in the 12 mm height. All other diameters are provided in the 15 mm height. Each abutment is supplied with a corresponding screw. Milling Abutment for CAD/CAM is compatible with the Thommen Implant System ELEMENT and CONTACT implants.

This document is a 510(k) Summary for a medical device called "Milling Abutment for CAD/CAM". It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed performance studies with statistical analysis as typically seen for AI/ML devices or novel technologies.

Therefore, much of the requested information cannot be directly extracted from this document, as it pertains to a different type of regulatory submission and device.

However, I can provide the information available that is relevant to "acceptance criteria" in the context of this 510(k) submission, and the "study" (non-clinical testing) used to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the performance standards and regulations the device must meet for substantial equivalence, and the "reported device performance" is the confirmation that these standards were met.

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

• Sample Size: The document does not specify a "test set" sample size in the context of an AI/ML algorithm evaluation. The non-clinical testing mentioned (sterilization, biocompatibility, input/output validation, mechanical testing) would have involved a sample of the manufactured devices or components, but the specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The "data" here refers to non-clinical test results from the manufacturer (Thommen Medical AG, Switzerland).

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

• This is not applicable as the device is not an AI/ML diagnostic algorithm that requires expert-established ground truth from a test set of images or medical records. The "ground truth" for this device's performance is established by adherence to engineering standards, material properties, and manufacturing specifications.

4. Adjudication Method for the Test Set

• Not applicable for this type of device and submission.

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 device is a dental abutment, a physical component, not an AI/ML software for assisting human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for validating this device's performance relies on:
  • Engineering Standards: ISO 17665-1, ISO 17665-2 (for sterilization); ISO 10993-1 (for biocompatibility); ISO 14801 (for mechanical testing).
  • Manufacturing Specifications: Established design parameters for wall thickness, angulation, height, etc., and the accuracy of the CAD/CAM library output.
  • Predicate Device Characteristics: The established safety and effectiveness of the legally marketed predicate devices to which this device is claiming "substantial equivalence."

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

• Not applicable.

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Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.

Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

The provided text is a 510(k) Summary for a medical device called "SPI® Titanium Base for CAD/CAM". This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets specific acceptance criteria in the manner one might describe for a diagnostic or AI-driven device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set size) are not applicable to this type of regulatory submission.

The "acceptance criteria" in this context refer to the demonstration of "substantial equivalence" to predicate devices based on design, materials, intended use, and operating principles, rather than performance metrics from a formal clinical or technical study against predefined thresholds.

Here's a breakdown based on the information provided and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission is for a dental abutment demonstrating substantial equivalence to predicate devices, not a diagnostic or AI device requiring a test set of data. The "study" here refers to the comparison of the device's characteristics against those of already cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 is a hardware device (dental abutment), not an AI-driven or diagnostic system.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

• Not Applicable in the traditional sense of a diagnostic study. The "ground truth" for this submission is established by the known characteristics and regulatory clearance of the predicate devices. The new device's characteristics are compared against these established devices.

8. The sample size for the training set

• Not Applicable. No training set is used for this type of submission.

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

• Not Applicable. See point 8.

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The SPI® Customizable Gingiva Former is intended to be used in conjunction with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.

The Thommen SPI® Customizable Gingiva Former is a temporary endosseous dental implant component made from an acrylic-based polymer with a titanium base at the implant/abutment interface for a stable, precise connection. The SPT® Customizable Gingiva Former is used for maintaining gingival contour and as a base for fabrication of a temporary restoration.

This 510(k) submission (K092248) for the Thommen Medical AG SPI® Customizable Gingiva Former does not contain the type of study data and acceptance criteria that would typically be found for a device requiring performance evaluation against specific metrics, especially for AI/ML-enabled devices.

This submission is a Special 510(k) for a device modification, specifically for an "Endosseous dental implant abutment." Special 510(k)s often involve modifications to already cleared devices where the changes do not significantly alter the fundamental scientific technology or intended use. In such cases, the review focuses on ensuring that the modifications do not raise new questions of safety and effectiveness, often relying on comparisons to the predicate device and established performance standards, rather than new extensive clinical or performance studies with detailed acceptance criteria and statistical analysis.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, etc.) are not applicable or present in this document.

Here's an analysis based on the provided text, addressing the requested information where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated or applicable in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics with acceptance criteria for a new type of study.

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

Not applicable. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The evaluation relies on the device description, intended use, and comparison to predicate devices, along with adherence to general controls.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment process is described, as there isn't a performance study generating new data for evaluation.

4. Adjudication Method

Not applicable. No performance study data requiring adjudication is presented.

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

Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would undergo such a study.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

Not applicable. There is no ground truth data in the context of a performance study for this device type.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of Device and Approval Context:

• Device Name: SPI® Customizable Gingiva Former
• Intended Use: Used with SPI® System dental implants to provide temporary support for crowns or bridges in the maxillary and/or mandibular arch.
• Classification: Class II (Endosseous Dental Implant Abutment)
• Nature of Submission: Special 510(k) for a device modification. This implies the core technology and safety/effectiveness principles were established by previous predicate devices.
• Key Argument for Equivalence:
  • Same intended use
  • Same operating principle
  • Same or similar materials
  • Same basic design
  • Same packaging materials and processes

The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the primary "acceptance criterion" for a 510(k) submission, and it is "proven" by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to the predicates, as outlined in the "Equivalence to Marketed Product" section.

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical strength limits with associated test results) are detailed in the provided portion, which is common for Special 510(k)s focusing on material or design modifications where existing general controls and predicate device performance are considered sufficient. If mechanical testing (e.g., fatigue, fracture) was performed to support the modification, the specific acceptance criteria and results would typically be in a separate section of the 510(k) submission, often referencing ISO or ASTM standards, but they are not provided in this excerpt.

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