IMPLANT CENTER 2 by SATELEC | FDA 510(k) Summary

The intended use of the Satelec Implant Center 2 is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

Device Description

The Satelec Implant Center 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.

AI/ML Overview

This document is a 510(k) summary for a dental operative unit called the "Implant Center 2." It primarily focuses on demonstrating substantial equivalence to a previously cleared device, not on presenting a study with specific acceptance criteria and performance data in the way a clinical study for a diagnostic AI device would.

Therefore, the sections of your request related to acceptance criteria, specific performance metrics (like sensitivity, specificity), ground truth, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies for AI interpretation are not applicable to this document. This filing is for a physical medical device (dental operative unit), not a digital health or AI-driven diagnostic tool.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

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

Not Applicable. This document does not describe specific numerical acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or diagnostic function. Its acceptance criteria fundamentally revolve around demonstrating "substantial equivalence" to a predicate device. The performance is assessed against the predicate's known safety and effectiveness for its intended use, rather than quantifiable performance metrics.

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

Not Applicable. No test set or data provenance is mentioned as this is not a study assessing AI performance or a diagnostic outcome. The "test" for this device is the comparison to the predicate device and assessment of manufacturing controls and safety features.

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 for a diagnostic test set is mentioned.

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

Not Applicable. No test set requiring expert adjudication is mentioned.

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. No MRMC study was done, as this is not an AI-assisted diagnostic or interpretation device.

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

Not Applicable. This device is a physical dental operative unit, not an algorithm.

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

Not Applicable. No ground truth for a diagnostic purpose is used. The "ground truth" for this filing is the safety and effectiveness of the predicate device as established by its prior clearance. The new device is intended to be as safe and effective as the predicate.

8. The sample size for the training set

Not Applicable. No training set is mentioned for an AI model.

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

Not Applicable. No training set ground truth to establish.

Summary regarding the device and its "study" for acceptance:

This document describes a 510(k) submission for a medical device (a dental operative unit) where the primary "study" and "acceptance criteria" revolve around demonstrating substantial equivalence to a previously cleared predicate device.

Acceptance Criteria (Implied by 510(k) Process): The device (Implant Center 2) must demonstrate that it is as safe and effective as the predicate device (Implant Center, K072030) for its intended use and does not raise new questions of safety or effectiveness. This is achieved by comparing device descriptions, technical specifications, performances, and intended uses.
Study/Evidence: The "study" isn't a clinical trial in the traditional sense, but a detailed comparison provided in the "Substantial Equivalence" section.
- Device Comparison: The Implant Center 2 and the predicate device are both "dental operative units that supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners."
- Conclusion: The document states, "Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center 2."

In essence, the "study" is a technical and functional comparison to show that the new device is essentially the same, with only minor differences that do not impact fundamental safety or effectiveness, as its predicate.

Summary

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SMDA Summary of Safety and Effectiveness - "510 (k) Summary" ത

JUL 2 2 2009

A. Submitter Information SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANČE

Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292

Contact Person: Rick Rosati

SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 Email: rick.rosati@us.acteongroup.com

Date Prepared:

04 / 30 / 2009 REVISED 7/16/09

B. Device Identification

"Bone Cutting Instrument and Accessories" Common Usual Name:

Proprietary Name:

Implant Center 2

C. Identification of the Predicate Device

Device	Applicant	510(k) No.	Date Cleared
Implant Center	Satelec	K072030	11 / 19 / 2007

The Satelec Implant Center 2 is substantially equivalent to the predicate device by Satelec, the Implant Center (K072030) previously cleared by the FDA and currently marketed.

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D. Device Description

The Satelec Implant Center 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.

E. Substantial Equivalence

The Implant Center 2 and the predicate device, Implant Center (K072030) are both dental operative units that supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center 2.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2000

SATELEC C/O Mr. Rick Rosati Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K091252

Trade/Device Name: IMPLANT CENTER 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Material and Accessories Regulatory Class: II Product Code: DZI Dated: April 29, 2009 Received: April 29, 2009

Dear Mr. Rosati:

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 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- Mr. Rosati

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sion Cunner

Susan Runner, D.D.S., M.A. 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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Indications for Use

510(k) Number:

Device Name:

IMPLANT CENTER 2

Indications for Use:

"The intended use of the Satelec Implant Center 2 is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. "

Prescription Use × (Part 21 CFR 801 Subpart D)

12 - 15 - 12 - 12 - 14

AND/OR

Over-The-Counter Use (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)

Ken Muly for MSR

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

510(k) Number: K091252

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.