The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Description

The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "LITe® Plate System," a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or AI-driven performance.

Therefore, many of the requested categories related to AI device performance evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document refer to the mechanical performance of the implant and its ability to meet established ASTM standards for orthopedic devices. The "study" demonstrating this is mechanical testing.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Mechanical)	Reported Device Performance (Summary)
Static and dynamic compression testing per ASTM F1717-14	Met predefined acceptance criteria via mechanical testing.
Static torsion testing per ASTM F1717-14	Met predefined acceptance criteria via mechanical testing.
Buttress plate expulsion testing	Met predefined acceptance criteria via mechanical testing.
Substantial equivalence to predicate due to identical indications, technological characteristics, and principles of operation, confirming minor differences do not impact device performance.	Demonstrated substantial equivalence through risk analysis and comparison to predicates.

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

Sample size: Not specified in terms of clinical patient data. For mechanical testing, the number of samples tested per condition is not explicitly stated, but typically follows standard testing protocols for ASTM standards.
Data provenance: Not applicable in the context of clinical or image data. The "data" pertains to mechanical test results.

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 mechanical devices is established by engineering specifications and recognized consensus standards (like ASTM F1717-14), not by expert human readers.

4. Adjudication method for the test set:

Not Applicable. Mechanical testing results are objective measurements against defined standards, not subjective assessments requiring adjudication.

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. This is a mechanical implant, not an AI diagnostic device.

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

Not Applicable. This is a mechanical implant, not an AI diagnostic device.

7. The type of ground truth used:

Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance relies on meeting the specifications outlined in ASTM F1717-14 and demonstrating comparable mechanical properties and functional equivalence to its predicate devices.

8. The sample size for the training set:

Not Applicable. This is a mechanical implant, not an AI device that requires a training set.

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

Not Applicable.

Summary of the Study:

The "study" referenced in the document is a risk analysis and mechanical testing comparison to predicate devices, not a clinical trial or AI performance study. The submission aimed to demonstrate substantial equivalence to already approved devices.

The key points of the study are:

Mechanical Testing: The device underwent static and dynamic compression testing per ASTM F1717-14, static torsion testing per ASTM F1717-14, and buttress plate expulsion testing.
Acceptance Criteria for Mechanical Testing: Predefined acceptance criteria associated with these tests were met. These criteria would be derived from the ASTM standards and comparisons to predicate device performance.
Comparison to Predicates: The LITe® Plate System was compared to its primary predicate (Stryker Spine, LITe® Plate System, K142699) and additional predicates (Stryker Spine, CENTAUR™ Spinal System, K994347, K001844). The comparison covered intended use, material composition, principles of operation, and design.
Conclusion: The risk analysis performed demonstrated that any minor differences between the LITe® Plate System and its predicates do not impact device performance, leading to the determination of substantial equivalence.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

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

March 20, 2015

Stryker Spine Garry Haveck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K150449 Trade/Device Name: LITe® Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 19, 2015 Received: February 20, 2015

Dear Dr. Hayeck:

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

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Page 2 - Garry Hayeck, Ph.D.

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 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)

K150449

Device Name LITe® Plate System

Indications for Use (Describe)

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);

· Pseudoarthrosis;
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
Tumors;
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· Failed Previous Fusion

The LITe® Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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	510(k) Summary: LITe® Plate System
Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-962-4043E-mail: garry.hayeck@stryker.com
Date Prepared	February 19, 2015
Trade Name	LITe® Plate System
Common Name	Appliance, fixation, spinal intervertebral body
Proposed Class	Class II
Classification Name and Number	Spinal intervertebral body fixation orthosis21 CFR §888.3060
Product Code	KWQ
Predicate Devices	Primary Predicate:Stryker Spine, LITe® Plate System, K142699Additional Predicate:Stryker Spine, CENTAUR™ Spinal System, K994347, K001844
Device Description	The LITe® Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The LITe® Plate System consists of plates and screws manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
Intended Use	The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);Pseudoarthrosis;Spondylolysis;Spondylolisthesis;Spinal stenosis;Tumors;Trauma (i.e. Fractures or Dislocation)Deformities (i.e. Scoliosis, Kyphosis or Lordosis)Failed Previous FusionThe LITe® Plate System Buttress Plate is intended to stabilize the allograft
510(k) Summary: LITe® Plate System
or autograft at one level (T1-S1) as an aid to spinal fusion and to providetemporary stabilization and augment development of a solid spinalfusion. It may be used alone or with other anterior, anterolateral, orposterior spinal systems made of compatible materials. This device is notintended for load bearing applications.
Summary of theTechnologicalCharacteristics	As established in this submission, the LITe® Plate System was shown tobe substantially equivalent and have equivalent technologicalcharacteristics to its predicate devices through comparison in areasincluding intended use, material composition, principles of operationand design.
Summary of thePerformance Data	Risk analysis was performed to demonstrate that the LITe® Plate Systemis substantially equivalent to its predicate devices. The risk analysisdetermined that the predefined acceptance criteria associated withthe following mechanical testing was met:● Static and dynamic compression testing per ASTM F1717-14● Static torsion testing per ASTM F1717-14● Buttress plate expulsion testing
Conclusions	The LITE® Plate System has identical indications, technologicalcharacteristics, and principles of operation as its predicates. The riskanalysis performed demonstrates that any minor differences do notimpact device performance as compared to the predicates. The LITE®Plate System was shown to be substantially equivalent to its predicatedevices.

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.