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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2016

Thommen Medical AG c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K151984

Trade/Device Name: Milling Abutment for CAD/CAM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2016 Received: February 11, 2016

Dear Ms. Schulz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151984

Device Name

Milling Abutment for CAD/CAM

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Thommen Medical AG

Milling Abutment for CAD/CAM K151984

March 7, 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name	Thommen Medical AG
	Neckarsulmstrasse 28
	2540 Grenchen, Solothurn
	Switzerland
	Telephone:	+41 61 965 90 20
	Fax:	+41 61 965 90 21
Official Contact	Daniel Snetivy
	Chief Technology Officer
Representative/Consultant	Linda Schulz, BSDH, RDH
	Floyd G. Larson
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Milling Abutment for CAD/CAM
Common Name:	Dental implant abutment
Classification Name:	Endosseous dental implant abutment
Classification Regulation:	21 CFR 872.3630, Class II
Product Code:	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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INDICATIONS FOR USE

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.

K122295	CORE 3D Abutment System forDigital Prosthetic Solutions	CORE 3D Protech, S.L.	Primary Predicate
K073713	Blue Sky Bio Dental Implant	Blue Sky Bio, LLC	Reference
	System		Predicate
K031747SPI® Dental Implant Abutments		Thommen Medical, AG	Reference
			Predicate
K090154	SPI® Dental Implant, INICELL®	Thommen Medical, AG	Reference
			Predicate

PREDICATE INFORMATION

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included the following: sterilization according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products – Moist heat - Part 2: Guidance on the application of ISO 17665-1; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process which determined that no further biocompatibility testing is required because all

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510(k) Summary Page 3 of 4

materials and processing are identical to the abutments cleared in K031747: Input/output validation for the Thommen Medical library performed to ensure accuracy and conformance to the parameters outlined for the Thommen Milling Abutment for CAD/CAM. Validation confirmed that accuracy was consistent and parameter limits were maintained in final device manufacturing. Static and dynamic compression -bending testing were performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.

Subject Device	Primary Predicate Device
Thommen Medical AG	CORE 3D Protech, S.L.
Milling Abutment forCAD/CAM	Core 3D Abutment System for Digital Prosthetic Solutions
K151984	K122295
Indications for use
Thommen Milling abutments forCAD/CAM are intended to beused in conjunction with	The CORE 3D abutment system for digital prosthetic solutions are dental abutmentsplaced into a dental implant to provide support for dental prosthetic restorations. Theabutments include:
Thommen System dentalimplants in the maxillary and /ormandibular arch to providesupport for crowns, bridges andoverdentures.	• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAMdesigned superstructure may be fitted to complete a two-piece dental abutment;• Titanium Abutment Blanks with a pre-machined implant connection where the upperportion may be custom-milled in accordance with a patient-specific design usingCAD/CAM techniques
All digitally designedabutments for use withThommen Milling abutmentsfor CAD/CAM are intendedto be sent to a Thommenvalidated milling center formanufacture.	• Abutment Screws to permanently fix the abutments to the underlying implant. Core 3Dabutments are intended for use to support single-tooth (unit) and multiple-tooth (bridgesand bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3Dallowable range of design specifications and be provided as straight abutments only.Core 3D abutments and are compatible for use with the following dental Implants:• Nobel Biocare Brånemark System (K022582, K934825)• Zimmer Tapered Screwvent (K013227, K061410, K072589)
Design
CAD/CAM Blank	CAD/CAM Blank,Titanium Base
Cement-retained	Cement-retained
Single-unit,Multi-unit	Single-unit,Multi-unit
3.5 - 6.0	3.5 - 5.7
Internal Hex	Internal Hex,External Hex

The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. Both abutments are being used in conjunction with dental implants for the purpose of supporting dental prostheses and are CAD/CAM custom abutments fabricated at a milling center.

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CONCLUSION

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, including diameter and length of the implants, and diameter, gingival height, and angle of the abutments. The subject and predicate devices are packaged in similar materials and to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)