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 (TI-LS) spine or via an anterior approach below the bifureation of the great vessels in the treatment of 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 Discase (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.

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 is a 510(k) summary for a medical device called the LITe® Plate System. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with specific metrics like sensitivity, specificity, or reader improvement.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human reader improvement with AI
If a standalone (algorithm only) performance study was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

The "Performance Data" section in the K142699 document refers to non-clinical mechanical testing, not a study of an AI/algorithm's diagnostic or predictive performance.

It states:
"Nonclinical testing was performed to demonstrate that the LITe® Plate System is substantially equivalent to its predicate devices. The following testing and analysis was performed:

Static and dynamic compression testing per ASTM F1717-14
Static torsion testing per ASTM F1717-14
Buttress plate expulsion testing"

This type of testing is to ensure the physical integrity and mechanical properties of the orthopedic implant meet established standards for similar devices, not to assess the performance of a diagnostic algorithm or AI system.

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 consists of a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 31, 2014

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

Re: K142699

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: October 2, 2014 Received: October 6, 2014

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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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 yours,

Mark N. Melkerson -S

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)

K142699

Device Name LITe(R) Plate System

Indications for Use (Describe)

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)

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	December 31, 2014
Trade Name	LITe® Plate System
Common Name	Appliance, fixation, spinal intervertebral body
Proposed Class	Class II
Classification Nameand Number	Spinal intervertebral body fixation orthosis21 CFR §888.3060
Product Code	KWQ
Predicate Devices	Primary Predicate: Stryker Spine, CENTAUR™ Spinal System, K001844
	Additional Predicates:
	Universal, Sacral, 2 Screw, and 4 Screw Plates
	• Stryker Spine, CENTAUR™ Spinal System, K994347
	• Medtronic, PYRAMID® +4 Anterior Lumbar Plate System, K080429
	• NuVasive, Lateral Plate System, K091071
	• Spinal USA, Anterior Lumbar Plate System, K091044
	• Globus Medical, CITADEL™ Anterior Lumbar Plate System, K062836
	• Stryker Spine, THOR Anterior Lumbar Plate, K080773
	Buttress Plate
	• Spinal USA, RCS Anterior Buttress Plate, K092659
	• Spinal USA, Anterior Lumbar Plate System, K091044
	• Stryker Spine, THOR Anterior Lumbar Plate, K080773
Device Description	The LITe® Plate System is an anterior/anterolateral/lateral plate systemthat may be used in the thoracic, lumbar, and sacral spine (T1-S1). TheLITe® Plate System consists of plates and screws manufactured fromtitanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well asassociated manual general surgical instrumentation. The implants areavailable in a variety of sizes to accommodate various patientanatomies.
Intended Use	The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates areindicated for use via a lateral or anterolateral surgical approach abovethe bifurcation of the great vessels in the treatment of the thoracic andthoracolumbar (T1-L5) spine or via an anterior approach below thebifurcation of the great vessels in the treatment of lumbar andlumbosacral (L1-S1) spine. The system is intended to provide additionalsupport during fusion in skeletally mature patients in the treatment of thefollowing acute and chronic instabilities or deformities:• Degenerative Disc Disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by patient history
510(k) Summary: LITe® Plate System
	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 allograftor 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	Nonclinical testing was performed to demonstrate that the LITe® PlateSystem is substantially equivalent to its predicate devices. The followingtesting and analysis was performed: 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 non-clinical test results demonstrate 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.