Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.

Device Description

The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "The Leibinger Advance Internal Midface Distraction System." This document is for a bone distraction system, which means it is a physical device used in surgery, not a diagnostic AI/ML algorithm.

Therefore, many of the requested fields related to AI/ML software performance (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not present in the provided text.

The information that can be extracted relevant to the "acceptance criteria" for a physical device typically comes from performance testing (e.g., mechanical, biocompatibility) demonstrating its safety and effectiveness, usually against established standards or predicate devices. However, this 510(k) summary provides a high-level overview and does not detail specific acceptance criteria or the studies that prove they are met in a quantitative manner (e.g., stress tests to a specific load, cycle tests to a specific number of cycles).

Here's a breakdown of what can be inferred or stated as "not applicable" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied/General)	Reported Device Performance (Implied/General)
Safety and Effectiveness for intended use	Substantially equivalent to legally marketed predicate devices.
Biocompatibility	(Not explicitly detailed in this summary, but would be part of a full submission)
Mechanical Performance (e.g., strength, durability, distraction capability)	"The plates and frame initially stabilize and then gradually distract the osteotomy." (Specific quantitative performance not provided in this summary).
Functionality (e.g., activation mechanism)	"Removable activation rod... provides the point of attachment for the activation key used to initiate the distraction of the osteotomy." (Specific quantitative performance not provided).
Intended Use Compatibility	Demonstrated to be suitable for "cranium and mid-face for which osteotomy and segmental advancement are indicated."
Regulatory Compliance	Reviewed by FDA as "substantially equivalent" to predicates, subject to general controls.

Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific quantitative performance acceptance criteria and results. A full 510(k) submission would contain detailed test reports.

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

N/A. This is a physical medical device. Performance is typically evaluated through bench testing (mechanical, material, sterility, biocompatibility) rather than a "test set" of data like an AI/ML algorithm.

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):

N/A. Ground truth establishment is relevant to diagnostic or AI/ML devices. For a physical device, performance is evaluated against engineering specifications, regulatory standards, and clinical outcomes (which are not detailed in this summary).

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

N/A. See point 3.

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:

N/A. This is not an AI-assisted diagnostic device.

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

N/A. This is not a standalone algorithm.

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

N/A. See point 3. The "truth" for this device's performance would be its ability to physically distract bones safely and effectively, demonstrated through mechanical tests and potentially clinical data (though not detailed here).

8. The sample size for the training set:

N/A. This is not an AI/ML device that requires a training set.

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

N/A. See point 8.

Summary

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K092743

510(k) Summary of Safety and Effectiveness

JAN 1 5 2010

Proprietary Name:	The Leibinger Advance Internal MidfaceDistraction System
Common Name:	Bone Distraction System
Classification Name and Reference:	Smooth or Threaded metallic bone fixation fastener21 CFR §888.4760
Proposed Regulatory Class:	Class II
Product Codes:	JEY - Bone Plate
For Information contact:	Stephanie FittsDirector, Regulatory Affairs and ComplianceHowmedica Osteonics.Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5405 Fax: (201) 831-4405
Date Prepared:	September 4, 2009

Description:

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Intended Use:

The Leibinger Advance Internal Midface Distraction System is intended to be used in conditions of the cranium and mid-face for which osteotomy and segmental advancement are indicated.

Indications:

Substantial Equivalence:

The Leibinger Advance Internal Midface Distraction System is substantially equivalent to other commercially available cranial and midface distraction systems. The following devices are examples of predicate systems: Cohen Distractor (K972154), Synthes Midface Distractor (K022005), Vazquez-Diner Intraoral Distractor (K964649) and Molina Orbital Malar Distractor (K003883).

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Food and Drug Administration 19905 New Hampshire Avenue Dacumem Control Room -WO68-0666 Silver Spring, MD 20997-9002

Stephanie M. Fitts, Ph.D. Director, Regulatory Affairs and Regulatory Compliance Howmedica Osteonics Corporation Stryker Craniomaxillofacial 325 Corporate Drive Mahwah, New Jersey 07430

JAN 1 5 2010

Re: K092743

Trade/Device Name: The Leibinger Advance Internal Midface Distraction System Regulation Number: 21 CFR 872:4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: December 29, 2009 Received: December 4, 2009

Dear Dr. Fitts:

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 - Dr. Fitts

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 (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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Anthom U. Nwin

Watson, BS, MS, MBA Anthony 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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K092743 Deficiency Response Page 3 December 29, 2009

Indications for Use Statement

510(k) Number (if known): K092743

Device Name: The Leibinger Advance Internal Midface Distraction System

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

RSBetz DDS for Dr. K.P. Muliy (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092743

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.