The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Device Description

The purpose of this submission is to introduce an expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation.

The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.

These cages consist of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have graft windows spanning endplate to endplate for graft containment and to aid in fusion throughout the interbody cage.

The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.

The Tritanium X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, and are provided sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage. This document is a regulatory submission to the FDA, not a study report detailing acceptance criteria and performance data for an AI-medical device.

The "Summary of the Performance Data" section does mention various mechanical tests performed on the device to demonstrate substantial equivalence to identified predicate devices, and compliance with FDA guidance documents and ASTM standards. However, these are physical and mechanical performance tests for an implantable device, not acceptance criteria or study results for an AI-powered medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The document is about an intervertebral body fusion device and its mechanical testing, not an AI device.

To answer your question directly based on the provided text:

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

Cannot be provided for an AI device. The document discusses the mechanical performance of an intervertebral body fusion device against standards like ASTM F2077, F2267-04, F1147-05, F1044-05, F1160-05, E8/E8M, and F2129-15, and compliance with various FDA guidance documents for orthopedic implants. These are physical performance metrics, not AI performance metrics.

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

Cannot be provided for an AI device. The document does not mention test set sample sizes or data provenance relevant to an AI model's performance (e.g., number of images, patient demographics, retrospective/prospective). It refers to the number of test articles used for mechanical testing of the physical implant.

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

Not applicable for an AI device in this document. The ground truth discussed (implicitly) in the document is the physical and mechanical properties of the device as measured by standardized tests, not expert-labeled data for an AI model.

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

Not applicable for an AI device in this document.

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 mentioned as this is not an AI device.

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

Not applicable; this is not an AI device.

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

Not applicable for an AI device. The "ground truth" for this medical device's performance involved adherence to established ASTM standards and FDA guidance documents for mechanical and material properties (e.g., strength, corrosion resistance, wear debris).

8. The sample size for the training set

Not applicable; this is not an AI device.

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

Not applicable; this is not an AI device.

In summary, the provided document is a 510(k) summary for a physical orthopedic implant (intervertebral body fusion cage), not an AI-powered medical device. Therefore, the information requested about AI device acceptance criteria and study data cannot be extracted from this text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

July 25, 2019

Stryker Spine Deirdre Jayko Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K183249

Trade/Device Name: Tritanium® X PL Expandable Posterior Lumbar Cage, Tritanium® X TL Expandable Curved Posterior Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 3, 2019 Received: July 5, 2019

Dear Deirdre Jayko:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Melissa Hall, M.S. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183249

Device Name

Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage

Indications for Use (Describe)

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

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)
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510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Manufacturer/Submitter:	Stryker Spine2 Pearl Ct.Allendale, NJ 07401
Contact Person :	Name: Deirdre JaykoPhone: (201) 749-8339Email: deirdre.jayko@stryker.com
Date Prepared:	11/20/2018
Trade Name:	Tritanium® X PL Expandable Posterior Lumbar CageTritanium® X TL Expandable Curved Posterior Lumbar Cage
Common Name:	Intervertebral body fusion device
Proposed Class:	Class II
Classification Name:	Intervertebral Body Fusion Device with Bone Graft, Lumbar (21 CFR §888.3080)
Product Code:	MAX
Predicate Devices:	Primary Predicates:AVS® PL Spacers (K151726)Additional Predicates:Tritanium® PL Posterior Lumbar Cage (K181014)Tritanium® TL Posterior Curved Lumbar Cage (K173476)Globus Rise® Spacers (K171848)
Device Description:	The purpose of this submission is to introduce an expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation.The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.These cages consist of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have graft windows spanning endplate to
510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
	endplate for graft containment and to aid in fusion throughout the interbody cage.
	The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.
	The Tritanium X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, and are provided sterile.
Indications for Use:	The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
	Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
	The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
Summary of theTechnologicalCharacteristics	The subject Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are hydraulically expandable interbody fusion devices. The subject devices share technological characteristics with the cited predicate devices and do not raise any new questions of safety and effectiveness. The below characteristics are shared between the subject and predicate devices: Graft windows for packing autogenous or allogenic bone Comparable heights, widths, lengths, and lordotic angles Serrations on the superior and inferior surfaces
510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Summary of thePerformance Data	Indicated for use with supplemental fixation Expandable in-situ Testing in compliance with:FDA's June 12, 2007 "Class II Special Controls Guidance Document:Intervertebral Body Fusion Device" was performed for the subject Tritanium X Cages and demonstrated substantially equivalent performance to the identified predicate devices. The following mechanical tests were performed: Static and Dynamic Compression (per ASTM F2077) Static and Dynamic Compression Shear (per ASTM F2077) Static and Dynamic Torsion (per ASTM F2077) Expulsion Subsidence (per ASTM F2267-04) Wear Debris Assessment Impaction Characterization of the Physical, Chemical, and Mechanical properties of the subject Tritanium X Cage was established through material testing which demonstrated that the porous surface design of the cage met, at minimum, the requirements outlined in the: FDA Guidance documents: "Guidance Document for TestingOrthopedic Implants with Modified Metallic Surfaces Apposing Boneor Bone Cement [April 28, 1994]", "Class II Special Controls GuidanceDocument: Knee Joint Patellofemorotibial and FemorotibialMetal/Polymer Porous-Coated Uncemented Prostheses [January 16,2003]", and guidance for "Technical Considerations for AdditiveManufactured Devices [December 5, 2017]" ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical ImplantApplications ASTM F1147-05: Standard Test Method for Tension Testing ofCalcium Phosphate and Metallic Coatings ASTM F1044-05: Standard Test Method for Shear Testing of CalciumPhosphate and Metallic Coatings ASTM F1160-05: Standard Test Method for Shear and BendingFatigue Testing of Calcium Phosphate and Metallic Medical andComposite Calcium Phosphate/Metallic Coating ASTM E8/E8M: Standard Test Methods for Tension Testing of MetallicMaterials
510(k) Summary: Tritanium® X PL Expandable Posterior Lumbar Cage &Tritanium® X TL Expandable Curved Posterior Lumbar Cage
	Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15: Standard test method forconducting cyclic potentiodynamic polarization measurements to determinethe corrosion susceptibility of small implant devices.Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 isused for pyrogenicity testing to achieve the Endotoxin limit of < 20EU/Device.
Conclusion	Based on the design features, the use of established well known materials,feature comparisons, indications for use, and results of the mechanical testing,the Tritanium X Cage has demonstrated substantial equivalence to the identifiedpredicate devices.

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.