STRYKER SPINE AVS PL PEEK SPACER by STRYKER SPINE

The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Description

AI/ML Overview

This 510(k) premarket notification describes a spinal implant (Stryker Spine AVS™ PL PEEK Spacer), not a diagnostic device with performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information regarding acceptance criteria for device performance, ground truth establishment, sample sizes for test/training sets, and expert consensus is not applicable in the context of this product type and submission.

The "acceptance criteria" for a device like this primarily revolve around substantial equivalence to predicate devices in terms of materials, intended use, and mechanical/biological function, as demonstrated through documentation and specific testing as required by FDA guidance for spinal systems.

Here's an attempt to address the applicable parts of your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

For the Stryker Spine AVS™ PL PEEK Spacer, the primary acceptance criterion for its 510(k) clearance was demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as existing spinal vertebral body replacement devices.

The "study" to prove this involves providing documentation and testing to compare the new device to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a spinal implant for structural support, not a diagnostic AI device, the "performance" is assessed through material properties, mechanical testing, and biocompatibility, rather than diagnostic metrics.

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (as summarized in the 510(k))
Material Equivalence: PEEK polymer	Documentation provided demonstrating equivalence in material to predicate devices. (The document mentions "material" in the summary of technological characteristics).
Sizes (Dimensions): New implant sizes for use.	Documentation provided demonstrating equivalence in sizes to predicate devices, and additional new implant sizes are introduced.
Indications for Use: Thoraco-lumbar spine (T1-L5) for vertebral body replacement, anterior decompression, and height restoration, with bone graft and supplemental fixation.	The Indications for Use are consistent with, or expanded from, the predicate devices, for vertebral body replacement due to tumor or trauma. The intended use of packing bone graft and supplemental fixation is specified.
Biocompatibility: Safe for implantation.	Not explicitly detailed in the provided summary, but is a standard requirement for implants and would have been part of the "compliance with FDA's Guidance for Spinal System 510(k)'s" which includes material safety assessments.
Mechanical Performance/Structural Integrity: Ability to support spinal loads.	"Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ PL PEEK Spacer." This guidance typically outlines required mechanical tests (e.g., compression, subsidence, fatigue).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the traditional sense of a diagnostic test set with patient data. The "test set" here would refer to the number of devices or materials subjected to engineering and biocompatibility tests. This information is not detailed in the provided 510(k) summary (e.g., number of implants tested for fatigue, number of material samples for biocompatibility).
Data Provenance: Not applicable as there's no patient data involved in a retrospective or prospective manner for this type of submission. The data provenance would be from internal lab testing (mechanical, material) and literature reviews for material safety, conducted by the manufacturer (Stryker Spine).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. For a spinal implant, "ground truth" isn't established by expert review of patient cases in the same way as for diagnostic devices. Mechanical performance standards, material science principles, and biocompatibility guidelines form the basis for "truth" in these evaluations.
Qualifications of Experts: Not applicable directly. The "experts" involved would be regulatory affairs specialists, engineers (mechanical, materials), and potentially surgeons for clinical input on intended use, but not for establishing a "ground truth" for a test set in the diagnostic sense.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "adjudication" in the sense of reconciling differing expert opinions on a diagnostic case. Compliance to engineering standards and biocompatibility tests are objective measures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance. This 510(k) is for a physical implant.
Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Standalone Study: No, this is not applicable. There is no algorithm or AI component in this spinal implant. "Standalone performance" refers to the diagnostic accuracy of an AI algorithm without human input.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's safety and effectiveness determination is based on:
- Engineering Standards and Bench Testing: Compliance with recognized mechanical testing standards (e.g., ISO, ASTM) for spinal implants, as referenced by "FDA's Guidance for Spinal System 510(k)'s May 3, 2004." This includes tests for static and dynamic (fatigue) compression, expulsion, and subsidence.
- Material Characterization: Verification of material properties (e.g., PEEK) against specifications and established biocompatibility data.
- Clinical Experience/History of Predicate Devices: The long-standing safe and effective use of the predicate devices provides a foundational "truth" that the new device, being substantially equivalent, should also be safe and effective.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. There is no AI algorithm or "training set" for an implant designed to provide structural support.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable.

Summary

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510(k) Premarket Notification

APR J 1 2005

510(k) Summary of Safety and Effectiveness:

Stryker Spine AVS™ PL PEEK Spacer

Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: Simona.Voic@stryker.com
Date Prepared	March 9, 2005
Trade Name	Stryker Spine AVSTM PL PEEK Spacer
Classification Nameand Number	Spinal Vertebral Body Replacement Device,21 CFR 888.3060
Product Code	MQP
Purpose of thepremarket notification	The purpose of this premarket notification is to add indications andnew implant sizes to the previously cleared Stryker Spine VertebralSpacer.
Predicate Devices	1) Stryker Spine Vertebral Spacer (K040731)2) Stryker Spine AVSTM TL PEEK Spacer (K042571)3) Medtronic Sofamor Danek VERTE-STACKTM SpinalSystem (K031780)4) DePuy Surgical Titanium MeshTM (K003043)5) Surgical Dynamics Mesh Cage System (K003709)
Intended Use	The Stryker Spine AVSTM PL PEEK Spacer is a vertebral bodyreplacement indicated for use in the thoraco-lumbar spine (T1-L5) toreplace a collapsed, damaged, or unstable vertebral body resected orexcised during partial and total vertebrectomy procedure due totumor or trauma, to achieve anterior decompression of the spinalcord and neural tissues, and to restore the height of a collapsed
Summary of theTechnologicalCharacteristics	vertebral body.It is recommended to pack bone graft material inside the implant.The Stryker Spine AVS™ PL PEEK Spacer is intended for use withsupplemental fixation. The supplemental fixation systems that maybe used with the Stryker Spine AVS™ PL PEEK Spacer include, butare not limited to, Stryker Spine plate or rod systems (XIA, SpiralRadius 90D, and Trio).
	Documentation is provided which demonstrates the Stryker SpineAVS™ PL PEEK Spacer to be substantially equivalent to itspredicate devices in terms of its material, sizes, and indications foruse. Testing to demonstrate compliance with FDA's Guidance forSpinal System 510(k)'s May 3, 2004 was completed for the StrykerSpinal AVS™ PL PEEK Spacer.

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APR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K050624

K050624
Trade/Device Name: Stryker Spine AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 9, 2005 Received: March 11, 2005

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section > ro(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substant in interested in for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosure) to regars names date of the Medical Device American so to commerce prior to May 26, 1776, the characterial and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Analystics (RMA) devices that have been reciassified in docordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmetic Act (Act) that do not roquire approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general magatestion, listing You may, merelove, market the dovices, belyer to the one of the sensual registration, listing of general controls provisions of the free meralies sequilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (secrated in the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connounce "Entroling cargers" on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Ood of reasons concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a subscance complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decertimation that your assess of a secret by other Federal agencies and ligit or any Federal statures and regularions daministered of not limited to: registration and listing (21 let comply with an the Act 3 requirements) news 801); good manufacturing practice requirements as setsen CFR Part 807); labeling (21 CFR Part 001); good frankat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2 - Ms. Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stypt Plurle

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_

Device Name:_Stryker_Spine AVS™ PL_PEEK_Spacer

Indications For Use:

The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated The Otlyker Spine / N C / 1-L5) to replace a collapsed, damaged, or for use in the thoraco lumbul opino ( + = => < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < > > > > > > unstable vertebrar body rooooted of the nechieve anterior decompression of the spinal procedures due to tradinal to tradinal to theight of a collapsed vertebral body. oord and nodial to pack bone graft material inside the implant.

The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine fixation: The supplicinal hiation of Jimited to, Stryker Spine plate rod or rod systems (XIA, Spiral Radius 90D, and Trio).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stent Clarke

on-() Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K050624

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.