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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization: Conformity to ISO 17665-1 and ISO 17665-2	Sterilization performed according to ISO 17665-1 and ISO 17665-2.
Biocompatibility: Conformity to ISO 10993-1	Biocompatibility evaluation according to ISO 10993-1. No further testing required as materials and processing are identical to abutments cleared in K031747.
Input/Output Validation (Accuracy): Accuracy and conformance to parameters for Thommen Milling Abutment for CAD/CAM	Validation confirmed that accuracy was consistent and parameter limits were maintained in final device manufacturing for the Thommen Medical library (used with the 3Shape CAD/CAM System).
Mechanical Strength: Conformity to ISO 14801 (Static and Dynamic Compression-Bending)	Static and dynamic compression-bending testing were performed according to ISO 14801. (The document states this was done, implying the results met the standard, but specific numerical outcomes or pre-defined acceptance limits for the testing are not provided in this summary).
Design Specifications: Minimum wall thickness, maximum angulation, gingival height, total height.	Document states that for digitally designed abutments: minimum wall thickness is 0.4 mm, maximum angulation is 20°, maximum gingival height is 7.0 mm, and total height is no greater than 15 mm and no shorter than 4.5 mm. (The implication is that the design and manufacturing process adhere to these specifications, as confirmed by input/output validation).
Substantial Equivalence: Similar intended use, technological characteristics, materials, physical dimensions to predicate devices.	The document concludes: "The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions... The subject and predicate devices are packaged in similar materials and to be sterilized using similar methods." This forms the primary "acceptance criterion" for this 510(k) submission.

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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