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 titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. 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

The provided document is a 510(k) premarket notification for a medical device called the "Integra® Laminoplasty System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study as would be common for AI/software devices.

Therefore, many of the requested categories for AI/software studies are not applicable directly to this submission. However, I can extract the relevant information from the document regarding the device and its testing:

Device Name: Integra® Laminoplasty System
Regulation Name: Spinal interlaminal fixation orthosis (21 CFR 888.3050)
Regulatory Class: Class II
Product Code: NQW

Here's an analysis based on the provided document:

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

Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as the predicate device. For the Integra Laminoplasty System, this was demonstrated through non-clinical testing.
Reported Device Performance: The device "demonstrated equivalent performance to the predicate systems through static testing per ASTM F2193." This implies that the mechanical properties tested under ASTM F2193 met or exceeded the performance of the predicate device(s). Specific quantitative performance metrics (e.g., tensile strength values, compression resistance values) are not provided in this summary.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device	Demonstrated equivalent performance to predicate systems through static testing per ASTM F2193.

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

The document describes non-clinical testing (static testing per ASTM F2193), not a test set for an algorithm. Therefore, "sample size" here refers to the number of physical samples tested. The document does not specify the number of samples tested under ASTM F2193.
Data Provenance: Not applicable, as it's non-clinical lab testing of physical components, not patient data.

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. This device is a mechanical implant; "ground truth" in the context of expert review for AI algorithms is not relevant here. The ground truth for mechanical performance is established by standardized testing methods (ASTM F2193) and engineering principles.

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

Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical image review or similar tasks for AI evaluations. This document describes mechanical testing of a medical implant.

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. The document explicitly states: "No clinical testing was required to demonstrate equivalence." Therefore, no MRMC study, or any clinical study involving human readers with or without AI assistance, was performed.

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

Not applicable. The "Integra® Laminoplasty System" is a physical medical device (implants and instruments) for surgery, not an algorithm or AI software. Therefore, there is no "standalone algorithm performance" to evaluate.

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

The "ground truth" for this device's performance, in the context of regulatory submission, would be its mechanical properties meeting or exceeding those of the predicate devices as determined by standardized laboratory testing (ASTM F2193). This is a physical, objective "ground truth" based on engineering standards.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary of what the document does provide regarding acceptance criteria and performance:

The acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices in areas including intended use/indications for use, technological characteristics, and performance. This equivalence was demonstrated through non-clinical static testing per ASTM F2193, showing "equivalent performance" to the predicate systems. Specific quantitative results from this testing are not included in the public 510(k) summary. No clinical testing or AI-related studies were performed or required for this submission.

Summary

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

March 23, 2015

SeaSpine, Incoporated Ms. Michelle Willis Director, Regulatory Affairs 2302 La Mirada Drive Vista, California 92081

Re: K150469

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: February 17, 2015 Received: February 23, 2015

Dear Ms. Willis:

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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Michelle Willis

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150469

Device Name Integra® Laminoplasty System

Indications for Use (Describe)

The Integra Laminoplasty System is intended for use in the lower thoracic spine (C3 to T3) for 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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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

|__| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Contact Details

Applicant Name:	SeaSpine, Inc. (A subsidiary of Integra LifeSciences Corporation)
Address:Phone number:Fax number:	2302 La Mirada Drive, Vista, CA 92081(760) 216-5104(760) 727-8891
Contact person:Email address:	Michelle Willis, - Director, Regulatory Affairsmichelle.willis@integralife.com
Date Prepared:	February 17, 2015

2. Device Name

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

3. Legally Marketed Predicate Device(s)

Predicate	510(k) Number	Product Code	Trade Name	Manufacturer
Primary	K130830	NQW	Integra Laminoplasty System	SeaSpine, Inc.
Reference	K091623	NQW	NuVasive (Leverage)Laminoplasty Fixation System	NuVasive, Inc.
Reference	K050082	NQW	CENTERPIECETM Plate Fixation System	Medtronic Sofamor DanekUSA, Inc.

4. Device Description

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5. Intended Use/Indications for use

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 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.

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.