Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.

Device Description

SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.

AI/ML Overview

The provided text is a 510(k) summary for a dental implant abutment (SPI® VARIOmulti Angled Abutment). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting entirely new clinical data or performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment will not be present in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
Reported Device Performance: No specific quantitative performance data is provided. The document states that the device is "substantially equivalent in indications and design principles to predicate devices."

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance
Substantial Equivalence to Predicate Device	Device is "substantially equivalent in indications and design principles to predicate devices."
Intended Use Conformance	Intended for use in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
Design Principles Consistency	Internal connection to implant, external hex prosthetic attachment, for multi-unit, screw-retained, prefabricated restorations.

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

Sample Size: Not applicable/not provided. This document doesn't describe a performance test set in the traditional sense with a specific sample size of units tested against acceptance criteria. The equivalence demonstration is likely based on design comparisons, materials testing, and adherence to relevant standards, not a clinical performance study with a "test set" of patients or devices.
Data Provenance: Not applicable. No specific experimental data from a "test set" of patients or devices is referenced.

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

Number of Experts: Not applicable/not provided. Ground truth establishment is not relevant in this 510(k) summary as it does not rely on a clinical "test set" requiring expert evaluation.

4. Adjudication method for the test set:

Adjudication Method: Not applicable/not provided. This is not a clinical study requiring adjudication of results.

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:

MRMC Study: No. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

Standalone Study: No. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

Type of Ground Truth: Not applicable. There is no specific "ground truth" referenced for performance testing in this document. Substantial equivalence in a 510(k) relies on comparison to a legally marketed predicate device's established safety and effectiveness.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Ground Truth Establishment for Training Set: Not applicable.

Summary of the Study (Equivalence Demonstration):

The "study" described in this 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria and specific performance metrics. Instead, it is a demonstration of substantial equivalence conducted as part of the FDA 510(k) premarket notification process.

Methodology: Thommen Medical AG "demonstrated that... the SPI® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices." This involves comparing the new device's indications for use, technological characteristics (design, materials, intended function, attachment mechanism), and performance (often non-clinical testing like mechanical strength, fatigue, biocompatibility, but no specific data is included in this summary) to those of a legally marketed predicate device.
Proof of Meeting Acceptance Criteria (Substantial Equivalence): The FDA's letter (K090153) explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially-equivalent... You may, therefore, market the device..." This letter serves as the FDA's "acceptance" that the device meets the regulatory requirements for market clearance based on substantial equivalence.

In essence, for a 510(k) submission, the "acceptance criteria" relate to regulatory compliance and the ability to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than achieving specific quantitative performance thresholds from a de novo study.

Summary

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510(k) Summary

MAR 2 7 2009

510(k) Summary

Thommen Medical AG Special 510(k): Device Modification

SPI® VARIOmulti Angled Abutment

Orlando Antunes

ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 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: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

SPI® VARIOmulti Angled Abutment Dental implant abutment Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch

INTENDED USE

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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Thommen Medical AG demonstrated that, for the purposes of FDA's regulation of medical devices, the SPT® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Public Health Service

MAR 2 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thommen Medical, AG C/o Ms. Linda K. Schulz, RDH, BSDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K090153

Trade/Device Name: SPI® VARIOmulti Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2009 Received: January 22, 2009

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-ffor 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Suita y. Michael O.m.d.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPI® VARIOmulti Angled Abutment

510(k) Summary

Indications for Use

510(k) Number (if known); K0910153

Device Name:

SPI® VARIOmulti Angled Abutment

Indications for Use:

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

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 Punner

Page 1 of

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

510(k) Number: k80063

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.)