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Implant:
The ELEMENT PF 3.0 is suitable for use in one-stage or two-stage surgical techniques for restoring chewing function. The ELEMENT PF 3.0 is suitable for immediate implantation in case of replacement of several teeth; prerequisites are good primary stability and appropriate occlusal loading. The ELEMENT PF 3.0 must only be used for replacement of the lateral incisors of the upper jaw and lateral incisors of the lower jaw.

VARIOunite PF 3.0:
Thommen Medical VARIOunite abutments PF 3.0 are only used in conjunction with the ELEMENT PF 3.0 and are for fabrication of provisional and final crowns in the anterior maxilla and mandible (upper lateral incisors, lower anterior teeth).
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

VARIOunite:
Thommen Medical VARIOunite abutments 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.
Digitally designed abutments for use with Thommen VARIOunite are intended to be sent to a Thommen validated milling center for manufacture.

ELEMENT Ø 3.0 is a self-tapping, root form, endosseous dental implant made of commercially pure titanium. It is provided in two surfaces (TST and INICELL) and five lengths (8.0, 9.5, 11.0, 12.5, and 14 mm). Subject device components available for the ELEMENT Ø 3.0 implant are the healing cap, gingiva former and VARIOunite abutments. VARIOunite abutments can be used for temporary restorations, permanent restorations, or CAD/CAM zirconia superstructures. The indications for previously cleared VARIQunite abutments have been expanded to include angulation of the CAD/CAM zirconia superstructures.

This document describes a 510(k) premarket notification for the Thommen Implant System, specifically focusing on the ELEMENT PF 3.0 dental implant and VARIOunite abutments.

Here's an analysis of the acceptance criteria and the study used to demonstrate equivalence, based on the provided text:

No specific acceptance criteria in terms of performance metrics (e.g., success rates, survival rates, specific mechanical thresholds for clinical outcomes) are explicitly stated in this document for the device. The submission focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device (predicate device).

The "study" or rather, the evidence provided, primarily consists of non-clinical testing data and comparisons to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit quantitative acceptance criteria or corresponding clinical performance metrics are provided in the document. The general "acceptance criteria" for a 510(k) submission are that the new device is "substantially equivalent" to predicate devices in terms of intended use, technological characteristics, and materials, and that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size: Not applicable in the context of clinical trials. For non-clinical testing (mechanical, sterilization, etc.), specific sample sizes are not detailed in this summary. These tests typically involve a pre-defined number of units/samples for each test type according to the relevant standard.
• Data Provenance: The data is non-clinical, originating from laboratory testing conducted to international (ISO, ASTM) and FDA guidance standards. The manufacturer is Thommen Medical AG, Switzerland. The data is not derived from human subjects or patient populations.

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 submission did not include clinical data or studies requiring expert review of patient cases to establish ground truth.

4. Adjudication Method for the Test Set

• This is not applicable as the submission did not include clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical data were included in this submission." This type of study is typically used for diagnostic or imaging devices, not for dental implants which rely on mechanical and biological performance demonstrated through non-clinical testing and clinical experience with similar devices.

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

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable limits set by recognized international standards (ISO, ASTM) and FDA guidance documents for each specific test (e.g., sterilization effectiveness, material strength, biocompatibility, packaging integrity).

8. The Sample Size for the Training Set

• This is not applicable. There is no software algorithm or AI model being trained for this device.

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

• This is not applicable as there is no software algorithm or AI model being trained for this device.

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VARIOflex Thommen Medical VARIOflex Abutments 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. VARIOtemp Thommen Medical VARIOtemp Abutments 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.

VARIOunite is a straight titanium dental implant abutment with retention groves that can be used for either permanent or temporary screw-retained or cement-retained restorations. Labeled as VARIOflex, it is provided with a burn-out sleeve for fabrication of a permanent restoration. Labeled as VARIOtemp, it is provided with a fabrication screw for fabrication of a temporary restoration. VARIOunite can be prepared to the appropriate occlusal height prior to fabrication of the restoration using the retention rings for guidance. VARIOunite is available with an indexed connection for crowns or a non-indexed connection for bridges. It is available in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to existing platform diameters of the Thommen System dental implants.

The provided text does not contain information about acceptance criteria for a medical device or a study proving its performance against such criteria. The document is an FDA 510(k) premarket notification letter for a dental implant abutment called "VARIOunite."

It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria.

The document discusses:

• Device Name: VARIOunite
• Regulation Number/Name: 21 CFR 872.3630, Endosseous Dental Implant Abutment
• Product Code: NHA
• Predicate Devices: K121334 (VARIOeco) and K120414 (OsseoSpeed™ Plus)
• Indications for Use: Support for crowns, bridges, and overdentures in conjunction with Thommen System dental implants.
• Device Description: Straight titanium dental implant abutment, available as VARIOflex (for permanent restorations) and VARIOtemp (for temporary restorations).
• Performance Data (Non-clinical): Sterilization validation (ISO 17665-1, ISO/TR 17665-2) and biocompatibility evaluation (ISO 10993-1).
• Clinical Data: Explicitly states, "Clinical data were not submitted in this premarket notification."
• Equivalence Comparison: A table comparing the subject device (VARIOunite) with the primary and reference predicate devices in terms of indications, design (straight, prepable/non-prepable), diameter, restoration type, implant connection, and material.

Therefore, I cannot provide the requested table or details about a performance study, sample sizes, experts, adjudication methods, or MRMC studies, as this information is not present in the provided text. The document clearly states that "Clinical data were not submitted in this premarket notification." and instead relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

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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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