The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® TL Spacers are to be implanted via posterior approach.

The AVS® TL Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

Device Description

The AVS® TL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The Stryker Spine AVS® TL PEEK Spacer is a "banana" shaped, hollow frame implant with lateral fenestrations. The spacers incorporate three (3) Tantalum marker pins to aid in radiographic visualization.
The Stryker Spine AVS® TL PEEK Spacer is available in a variety of sizes, from 7 mm to 18mm in height, two (2) lengths: 25 mm and 30 mm and one (1) width: 9 mm. There are also 0° parallel and 4° wedge shaped options, which allows the surgeon to best choose the size suited to the patient's anatomy and pathology.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Stryker Spine AVS® TL PEEK Spacers. This is a submission for a spinal implant, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies on human performance or AI performance.

Therefore, many of the requested categories related to acceptance criteria, AI performance, ground truth, and expert adjudication are not applicable (N/A) to this type of submission. The provided document is a regulatory submission for a physical medical device, not an AI/ML software device.

Here's a breakdown of the applicable and non-applicable information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a medical device like a spinal spacer, "acceptance criteria" and "reported device performance" are typically related to mechanical properties, biocompatibility, and material characteristics, which are implicitly covered by demonstrating compliance with FDA guidance and substantial equivalence. The document does not provide a specific table of numerical acceptance criteria or performance metrics in the format usually requested for AI/ML devices.

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated for this type of device in the provided text)	Reported Device Performance (Summary)
Mechanical Performance	Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device"	Demonstrated "substantial equivalent performance characteristics to the identified predicate device systems."
Material Properties	Biocompatibility, PEEK material specifications	Not explicitly detailed, but implied to be equivalent to predicate devices and suitable for implantation.
Radiographic Visibility	Ability to visualize post-implantation	Incorporates "three (3) Tantalum marker pins to aid in radiographic visualization."
Design Specifications	Range of sizes, shapes (banana-shaped, hollow frame, lateral fenestrations)	Available in 7mm to 18mm height, 25mm and 30mm lengths, 9mm width, 0° parallel and 4° wedge shaped options.

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

N/A. This device submission does not involve a "test set" in the context of AI/ML performance evaluation. The "testing" referred to is likely a battery of non-clinical mechanical and material tests.

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

N/A. Ground truth and expert establishment are not relevant for this type of device submission.

4. Adjudication method for the test set

N/A. Adjudication methods are not relevant for this type of device submission.

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

N/A. This is a physical medical device, not an AI/ML software, so MRMC studies are not applicable.

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

N/A. This is a physical medical device.

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

N/A. Ground truth for AI/ML is not relevant for this device. For this type of spinal implant, the "truth" is established by adherence to design specifications, material standards, and successful performance in biomechanical testing.

8. The sample size for the training set

N/A. This device submission does not involve a "training set" for AI/ML.

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

N/A. This device submission does not involve a "training set" or its ground truth establishment.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' was performed for the AVS® TL PEEK Spacers and demonstrated substantial equivalent performance characteristics to the identified predicate device systems."

This indicates that the "study" was a series of non-clinical tests (likely mechanical, material, and possibly biocompatibility tests) conducted according to the guidelines outlined in the FDA's special controls guidance for intervertebral body fusion devices. The primary goal of this testing was to demonstrate that the AVS® TL PEEK Spacers are substantially equivalent in performance and safety to the predicate devices (Stryker Spine AVS® PL PEEK Spacers: K073470 and DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System: P960025). This implies that the device met the performance and safety criteria established by the FDA for such devices, as evidenced by its substantial equivalence to already cleared devices.

Summary

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K058366|

Stryker Spine AVS® TL PEEK Spacers

Traditional 510(k) Premarket Notification

FEB ஓ 7 2009

510(k) Summary: AVS® TL PEEK Spacers

Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Ms. Kimberly LaneRegulatory Affairs SpecialistPhone: 201-760-8215FAX: 201-760-8415Email: kimberly.lane@stryker.com
Date Prepared	December 9, 2008
Trade Name	Stryker Spine AVS® TL PEEK Spacers
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fusion device, 21 CFR 888.3080
Product Code	MAX
Predicate Devices	Stryker Spine AVS® PL PEEK Spacers: K073470DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP SpineSystem: P960025.
Device Description	The AVS® TL Peek Spacers are intervertebral body fusiondevices intended for use as an aid in spinal fixation. The StrykerSpine AVS® TL PEEK Spacer is a "banana" shaped, hollowframe implant with lateral fenestrations. The spacers incorporatethree (3) Tantalum marker pins to aid in radiographicvisualization.The Stryker Spine AVS® TL PEEK Spacer is available in avariety of sizes, from 7 mm to 18mm in height, two (2) lengths:25 mm and 30 mm and one (1) width: 9 mm. There are also 0°parallel and 4° wedge shaped options, which allows the surgeonto best choose the size suited to the patient's anatomy andpathology.
Intended Use	The Stryker Spine AVS® TL PEEK Spacers are intervertebralbody fusion devices indicated for use with autogenous bone graftin patients with degenerative disc disease (DDD) at one level ortwo contiguous levels from L2 to $1.DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.The AVS® TL PEEK Spacers are to be implanted via posteriorapproach.The AVS® TL PEEK Spacers are intended to be used withsupplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine (i.e., posterior pedicle screw androd systems).
Summary of theTechnologicalCharacteristics	Testing in compliance with FDA's June 12, 2007 "Class IISpecial Controls Guidance Document: Intervertebral BodyFusion Device" was performed for the AVS® TL PEEK Spacersand demonstrated substantial equivalent performancecharacteristics to the identified predicate device systems.

pg 1 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with outstretched wings and three legs.

Public Health Service

FEB 2-7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Stryker Spine Ms. Kimberly Lane 2 Pearl Court Allendale, New Jersey 07401

Re: K083661

Trade/Device Name: Stryker Spine AVS® TL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 9, 2008 Received: December 10, 2008

Dear Ms. Lane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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,

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Page 2 – Ms. Kimberly Lane

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R.A. m.d. fo

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Stryker Spine AVS® TL PEEK Spacers

Traditional 510(k) Premarket Notification

Indications for Use

510(k) Number (if known): KOS 3461 Device Name: Stryker Spine AVS® TL PEEK Spacers

Indications For Use:

The AVS® TL Spacers are to be implanted via posterior approach.

The AVS® TL Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

Prescription Use (Part 21 CFR 801 Subpart D) 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)

AND/OR

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Numbe

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.