Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.

Device Description

SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPI® VARIO Angled Abutment.

It's important to note that the provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or performance against specific acceptance criteria in the way an AI/ML device study might. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence through performance testing, primarily mechanical, rather than predictive accuracy.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Equivalence)	Reported Device Performance and Basis for Acceptance
Mechanical Performance: Equivalent to predicate devices	Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801. (ISO 14801 is a standard for fatigue testing of dental implants and abutments, implying the device met mechanical durability requirements comparable to predicates).
Biocompatibility: Equivalent to predicate devices	Made of the same materials (titanium) as the predicate devices, which are already deemed safe and effective for biocompatibility.
Design Principles: Same as predicate devices	Incorporates the same basic design, internal hex feature, precision fit interface, and is intended for screw-retained restorations. Designed for correction of implant divergence.
Intended Use: Same as predicate devices	Intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges, same as predicate devices.
Technological Characteristics: No new issues of safety or efficacy	Any differences in technological characteristics (compared to predicates) do not raise new issues of safety or efficacy, implying that minor design variations did not negatively impact performance or safety compared to the established predicate. Uses the same operating principle.
Sterilization & Packaging: Same as predicate devices	Similar packaging and sterilized using similar methods and materials.

Study Details (Based on available 510(k) Summary Information)

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "performance testing" referenced is mechanical testing (ISO 14801), which would involve a certain number of physical units subjected to cyclic loading. This is physical device testing, not a clinical data test set.
- Data Provenance: Not applicable in the sense of clinical data. This refers to laboratory-based mechanical testing of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering standards (like ISO 14801), not expert interpretation.
Adjudication method for the test set: Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For the mechanical aspects, the ground truth is established by the specified ISO 14801 standard and the physical properties and failure points observed during testing. For biological aspects, it's the known biocompatibility and safety profile of the titanium material used, supported by the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.

Summary of the Study:

The "study" described in this 510(k) summary is not a clinical trial or an AI/ML performance study. Instead, it's a benchtop performance testing study focused on mechanical properties. The central purpose of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to establish novel clinical effectiveness or safety from a blank slate.

The key study mentioned is:

Method: Performance testing "included methods described in ISO 14801." ISO 14801 is an international standard for dynamic loading of endosseous dental implants. This standard specifies methods for fatigue testing, which is crucial for dental implant components that experience cyclic forces during chewing.
Purpose: To show that the SPI® VARIO Angled Abutment performs mechanically at a level comparable to the predicate devices and meets established industry standards for durability and strength.
Conclusion: The results of this testing, combined with the similarity in materials, design principles, and intended use, were deemed sufficient by the FDA to demonstrate substantial equivalence to the predicate devices (K031747, K072856, K090153), leading to the clearance of the device.

Summary

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NOV 1 0 2011

510(k) Summary

SPI® VARIO Angled Abutment

510(k) Summary

Thommen Medical AG SPI® VARIO Angled Abutment K111984

October 27, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland +41 61 965 90 20 Telephone: Fax: +41 61 965 90 21

Official Contact:

Minna Buser, RA Manager

Representative/Consultant:

Linda K. Schulz, BSDH, RDH Kevin A. Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: Ischulz@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	SPI® VARIO Angled Abutment
Common Name:	Dental implant abutment
Classification Name:	Abutment, Implant, Dental, Endosseous
Classification Regulations:	21 CFR 872.3630, Class II
Product Code:	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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510(k) Summary

SPI® VARIO Angled Abutment

INTENDED USE

Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Thommen Medical AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical devices SPI® VARIO Angled Abutment is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Thommen Medical AG, SP1® Dental Implant Abutments cleared under K031747 Thommen Medical AG, SPI® VARIOmulti Abutment cleared under K072856 Thommen Medical AG, SPI® VARIOmulti Angled Abutment cleared under K090153

The subject device and the predicate devices have the same intended use, the same technological characteristics, are made of the same materials, and encompass the same range of physical dimensions. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.

Overall, SP1® VARIO Angled Abutment has the following similarities to the predicate devices:

. has the same intended use,
uses the same operating principle, ●
incorporates the same basic design, .
incorporates the same or very similar materials, and ●
has similar packaging and is sterilized using the same materials and processes .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

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

NOV 1 0 2011

Thommen Medical, AG C/O Ms. Linda K. Schulz Regulatory Affairs Consultant PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K111984

Trade/Device Name: SPI® VARIO Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 27, 2011 Received: October 28, 2011

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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Page 2 - Ms. Schulz

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K///984

SPI® VARIO Angled Abutment

Indications for Use

510(k) Number: K111984

SPI® VARIO Angled Abutment Device Name:

Indications for Use:

Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rums

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111984

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.)