The Aesculap Implant Systems Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Device Description

The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium Alloy and will be provided non-sterile and or sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the Aesculap Implant Systems Laminoplasty Plating System. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text.

Here is an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

The document states: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." and "Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market."

However, specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) and the corresponding quantitative performance results of the Aesculap device are not provided. The assessment relies on a qualitative statement of "similar in performance" and "comparable to other predicate systems."

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria, but implied to be similar to legally marketed spinal systems.	Similar in performance to previously cleared spinal systems with similar indications.
Not explicitly stated as numerical criteria, but implied to be comparable in safety and effectiveness to predicate systems.	Safe and effective comparable to other predicate systems currently on the market.

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

This information is not provided in the document. The text only mentions "biomechanical testing" and "testing results" without details on sample sizes or data provenance.

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):

This information is not applicable as the document describes biomechanical testing of a medical device, not a diagnostic or screening device that would require expert-established ground truth.

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

This information is not applicable for biomechanical testing.

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:

This information is not applicable as this is a physical implant device, not an AI-assisted diagnostic or imaging device.

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

This information is not applicable as this is a physical implant device, not an algorithm.

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

The "ground truth" for biomechanical testing would typically be engineering standards or established physical properties. The document states that testing was done per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" and "Spinal System 510(k)s." This implies the use of established engineering and regulatory testing standards to define acceptance.

8. The sample size for the training set:

This information is not applicable as this is a physical implant device, not an AI/ML system that requires a training set.

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

This information is not applicable as this is a physical implant device, not an AI/ML system.

Summary

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K090354

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510(k) SUMMARY (as required by 21 CFR 807.92) B.

Aesculap Implant Systems Laminoplasty Plating System

January 15, 2009

COMPANY:	Aesculap® Implant Systems (AIS), Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 6005673311	MAY 12 2009
CONTACT:	Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax)
TRADE NAME:	AIS Laminoplasty Plating System
COMMON NAME:	Appliance, Fixation, Interlaminal
CLASSIFICATION NAME:	Orthosis, Spine, Plate, Laminoplasty, Metal
REGULATION NUMBER:	21 CFR 888.3050
PRODUCT CODE:	NQW

SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems (AIS) believes that the Laminoplasty Plating System is substantially equivalent to the Synthes Arch Fixation System (K032534).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impinqement of the spinal cord.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The AIS Laminoplasty Plating System is considered substantially equivalent to other leqally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications.

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PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where relevant. Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market.

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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 features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Public Health Service

Aesculap® Implant Systems (AIS), Inc. % Ms. Lisa M. Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K090354

Trade/Device Name: Aesculap Implant System Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: February 9, 2009 Received: February 11, 2009

Dear Ms. Stanners:

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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requircments 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.

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Page 2- Ms. Mary Stanners

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) 276-0120. 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,

Chateau buchnu

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Aesculap Implant Systems Laminoplasty Plating System

Indications for Use:

Prescription Use and/or Over-the-Counter Use (Part 21 CFR 801 Subpart D) (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)

him Hici for MLM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090354

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.