The Thommen SPI® EASY Ø 4.0 Abutment is intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures.

Device Description

The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 platform components.

AI/ML Overview

This document is a 510(k) Summary for a medical device modification, specifically the "SPI® EASY Ø 4.0 Abutment." It does not include acceptance criteria or a study that proves the device meets those criteria in the typical sense of a performance study for a diagnostic or AI device.

Instead, this submission is focused on demonstrating substantial equivalence to an existing predicate device, primarily through a comparison of design, materials, and intended use for a modified dental implant abutment.

Here's an analysis based on your request, highlighting where the requested information is not applicable to this type of submission:

1. A table of acceptance criteria and the reported device performance

Not Applicable in this context. For a 510(k) submission seeking substantial equivalence for a modified device (especially a Class II dental abutment), the "acceptance criteria" are typically related to mechanical properties, biocompatibility, and sterilization, ensuring they are equivalent or superior to the predicate. Performance is demonstrated through comparison to the predicate, not a clinical efficacy study with specific metrics like sensitivity/specificity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission does not describe a clinical performance study with a "test set" of patients or data. The "test" for this device is likely engineering bench testing (e.g., fatigue, torque strength), which would be compared against established standards or predicate device performance. These details are not typically provided in the 510(k) Summary but would be in the full submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment by clinical experts is mentioned, as this is not a diagnostic device requiring interpretation of clinical data in a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical study involving expert adjudication is described.

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 is a hardware modification for a dental implant abutment, not an AI or diagnostic imaging device. An MRMC study is not relevant here.

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

Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. There is no "ground truth" in the clinical sense mentioned in this 510(k) summary. Performance would be assessed through engineering and materials testing against specifications and comparison to the predicate.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not Applicable. As above, no training set or ground truth is applicable here.

Summary of what the document does provide regarding "acceptance" for this specific device:

The "acceptance" in this context is meeting the criteria for substantial equivalence to a predicate device. The document explicitly states the similarities to the unmodified predicate SPI EASY Dental Implant Abutment:

Intended Use: Same
Operating Principle: Same
Basic Design: Same
Materials: Same
Packaging: Same

The modification is described as "to add additional abutments to fit the 4.0 platform components." The FDA's letter (Page 2-3) confirms they have reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market subject to general controls.

This is a regulatory acceptance based on equivalence, rather than a performance acceptance based on clinical study metrics.

Summary

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SPI® EASY Ø 4.0 Abutment

510(k) Summary

Thommen Medical AG Special 510(k): Device Modification

SEF 1 9 2007

SPI® EASY Ø 4.0 Abutment

ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

Official Contact:

Representative/Consultant:

Orlando Antunes

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: Ischulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code Classification Panel: Reviewing Branch:

SPI® EASY Ø 4.0 Abutment Dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3640), Class II NHA Dental Products Dental Devices

ESTABLISHMENT REGISTRATION

The Establishment Registration number for Thommen Medical AG is 3003836985. The Owner/Operator number is 9051144.

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510(k) Summary

INTENDED USE

DEVICE DESCRIPTION

The design of the SPI EASY Abutment System has been modified to add additional abutments to fit the 4.0 platform components.

EQUIVALENCE TO MARKETED PRODUCT

The SPI EASY Ø 4.0 Abutment has the following similarities to the unmodified predicate SPI EASY Dental Implant Abutment:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design,
· incorporates the same materials, and
· is packaged using the same materials and processes.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 1 9 2007

Re: K071453

Trade/Device Name: SPI® EASYØ 4.0 Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 22, 2007 Received: August 23, 2007

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.

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 (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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Syndie Y. Michael Davis

Chiu Lin, Ph.D. 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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Indications for Use

Applicant:

Thommen Medical AG

510(k) Number (if known): K071453

SPI® EASY Ø 4.0 Abutment Device Name:

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:	1671453
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Page 14 of 131

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.)