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 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/Titanium Alloy and will be provided non-sterile and or sterile.

AI/ML Overview

The provided documentation describes a medical device, the "Aesculap Implant Systems Laminoplasty Plating System," which underwent a 510(k) premarket notification. This submission relies on performance data from in vitro testing rather than clinical studies or AI/algorithm performance. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for AI, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from referenced ASTM standards)	Reported Device Performance (Summary)
ASTM F2193 (Static and Dynamic Bending)	Results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems.
ASTM F543 (Screw Pull-out testing)	Results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems.

Explanation of Performance: The device's performance was measured against the standards set by ASTM F2193 (for static and dynamic bending) and ASTM F543 (for screw pull-out). The submission states that the testing results demonstrate the device is "safe and effective comparable to other predicate systems currently on the market," implying that it met or exceeded the performance of these predicates under the specified tests. Specific numerical values for the acceptance criteria or the device's performance are not provided in this summary.

Regarding AI-specific questions (not applicable to this device submission):

2. Sample size used for the test set and the data provenance: Not applicable. This device relies on in vitro mechanical testing, not a data-driven algorithm with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro mechanical testing is based on engineering principles and measurements rather than expert human interpretation of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component.
7. The type of ground truth used: For this device, the "ground truth" for demonstrating safety and effectiveness comes from the engineering principles and material science underlying the ASTM standards (F2193 and F543). The outcome measures are physical properties (e.g., bending strength, pull-out force) measured directly, rather than medical observations.
8. The sample size for the training set: Not applicable. No AI component.
9. How the ground truth for the training set was established: Not applicable. No AI component.

Summary of the Study and Device Approval:

The "study" in this context refers to the performance testing conducted according to recognized industry standards (ASTM F2193 and F543).

Study Type: In vitro mechanical testing.
Purpose: To demonstrate the mechanical safety and effectiveness of the AIS Laminoplasty Plating System.
Methodology: The system underwent static bending, dynamic bending, and screw pull-out testing.
Result: The testing reportedly demonstrated that the device is "safe and effective comparable to other predicate systems currently on the market." This comparison implies that the device performed equivalently to, or better than, legally marketed predicate devices that have established safety and effectiveness.
Clinical Testing: No clinical testing was performed for this submission; the 510(k) relies solely on the in vitro performance data and substantial equivalence to predicates (AIS Laminoplasty Plating System (K090354) and Synthes AFS (K032534)) based on material, design, function, and intended use.

This 510(k) clearance (K103284) was granted based on the demonstration of substantial equivalence to predicate devices through in vitro performance testing, rather than through clinical trials or AI algorithm validation.

Summary

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

Aesculap Implant Systems Laminoplasty Plating System October 1, 2010

DEC - 2 2010

COMPANY:	Aesculap® Implant Systems (AIS), Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax)
TRADE NAME:	AIS Laminoplasty Plating System
COMMON NAME:	Appliance, Fixation, Interlaminal
CLASSIFICATION NAME:REGULATION NUMBER:PRODUCT CODE:	Orthosis, Spine, Plate, Laminoplasty, Metal21 CFR 888.3050NQW

INDICATIONS FOR USE

DEVICE DESCRIPTION

PERFORMANCE DATA

Testing of the Laminoplasty Plating System was performed in accordance with ASTM F2193 and F543 (static and dynamic bending and screw pull-out testing). Testing results demonstrate the AIS Laminoplasty Plating System is safe and effective comparable to other predicate systems currently on the market. No clinical testing was performed.

SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems (AIS) believes that the Laminoplasty Plating System is Alooolap "In plaint to the AIS Laminoplasty Plating System (K090354) and the Synthes AFS (K032534).

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

I LoriNoLOGio in this submission, the components of the AIS Laminoplasty Plating System is shown to be substantially equivalent and has the same technological characteristics to its shown to be oubotantially comparison in design, intended use, material, function and range of sizes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Aesculap Implant Systems, Inc. % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

DEC - 2 2010

Re: K103284

Trade/Device Name: AIS Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: November 04, 2010 Received: November 05, 2010

Dear Ms. Boyle:

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Ms. Lisa M. Boyle

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Page 1 of 1

A. INDICATIONS FOR USE STATEMENT

DEC - 2 2010

K10 3284 510(k) Number:__

Device Name: Aesculap Implant Systems Laminoplasty Plating System

Indications for Use:

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.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
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)

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

KID3284 510(k) Number_

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.