The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra "Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

Device Description

The Integra® Laminoplasty System consists of plates and screws that are attached to the lamina after a laminoplasty procedure; the system is manufactured from Titanium 6Al-4V ELI per ASTM F136. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage

AI/ML Overview

This 510(k) summary for the Integra® Laminoplasty System describes a medical device clearance based on substantial equivalence, rather than a study proving the device meets specific acceptance criteria through AI or clinical performance. Therefore, most of the requested information regarding AI study design, ground truth, and expert evaluation is not applicable.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Equivalent performance to predicate devices through static and dynamic mechanical testing per ASTM F2193	Demonstrated equivalent performance to the predicate systems through static and dynamic mechanical testing per ASTM F2193.

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The testing involves mechanical evaluation of the device components, not patient data.
Data Provenance: Not applicable, as this refers to mechanical testing, not a clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F2193) and the results of the physical tests.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable. Mechanical testing results are typically measured against established engineering standards.

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

No MRMC study was done. This document describes a medical device, not an AI system. The submission explicitly states: "No clinical testing was required to demonstrate equivalence."

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For the non-clinical testing: The "ground truth" is defined by the performance characteristics and requirements outlined in the ASTM F2193 standard for spinal intervertebral body fixation devices. The device's mechanical performance is compared to that of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable. There is no training set.

Summary of the K130830 Submission:

This 510(k) submission for the Integra® Laminoplasty System is based on substantial equivalence to existing legally marketed predicate devices. The primary evidence presented for regulatory clearance is non-clinical mechanical testing conducted according to ASTM F2193. The purpose of this testing was to demonstrate that the new device performs equivalently to the predicate devices in terms of static and dynamic mechanical properties. No clinical studies, AI performance evaluations, or expert consensus on clinical outcomes were required or performed for this clearance.

Summary

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K130830 - Page 1 of 2

510(k) Summary

MAY 0 9 2013

1. Contact Details

Applicant Name:	SeaSpine, Inc. (A subsidiary of Integra LifeSciences Corporation)
Address:	2302 La Mirada Drive, Vista, CA 92081
Phone number:	(760) 727-8399
Fax number:	(760) 727-8809
Contact person:	Jeff Brittan, - Director, Engineering
Email address:	jeff.brittan@integralife.com
Date Prepared:	March 18, 2013

Device Name

Integra® Laminoplasty System Trade Name: Common Name: Lamioplasty Plating System Classification Name: Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050) Product Code: NQW, Class II

3. Legally Marketed Predicate Device(s)

510(k) Number	Product Code	Trade Name	Manufacturer
K091623	NQW	NuVasive (Leverage) LaminoplastyFixation System	NuVasive, Inc.
K050082	NQW	CENTERPIECE™ Plate Fixation System	Medtronic SofamoreDanek USA, Inc.

4. Device Description

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5. Intended Use/Indications for use

The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra® Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

6. Substantial Equivalence Comparison

The Integra® Laminoplasty System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

7. Non-clinical Testing

The Integra® Laminoplasty System demonstrated equivalent performance to the predicate systems through static and dynamic mechanical testing per ASTM F2193.

8. Clinical Testing

No clinical testing was required to demonstrate equivalence.

9. Conclusions

The submitted data demonstrate that the Integra® Laminoplasty System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate devices.

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Public Health Service

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

May 9, 2013

SeaSpine, Incorporated Mr. Jeff Brittan 2302 La Mirada Drive Vista, California 92081

Re: K130830

Trade/Device Name: Integra® Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: March 18, 2013 Received: March 26, 2013

Dear Mr. Brittan:

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. Iisting 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Image /page/3/Picture/7 description: The image shows the name "Erin FD Keith" in a stylized font. The words "Erin" and "Keith" are in a standard font, while the letters "FD" are in a more decorative, geometric style. The letters "FD" have a pattern of lines and shapes within them, making them stand out from the rest of the text.

For

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

Enclosure

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Integra® Laminoplasty System 510(k)

K130830 Page 1 of 1

Indications for Use Statement

510(k) Number: K130830

Device Name: Integra® Laminoplasty System

Indications for Use:

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)

Ronald#AJean -S

(Division Sign-Off)

Division of Orthopedic Devices

510(k) Number: K130830

Page 1 of 1

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.