The Stryker Spine AVS™ ASL 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 procedures 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™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Description

This Special 510(k) submission is intended to introduce sixteen new sizes of the AVSTM AS PEEK Spacer to the Stryker Spine AVSTM ASL PEEK Spacer, determined Substantially Equivalent via 510(k) #K051205. The new sizes all have the Anterior/Posterior (AP) and Medial/Lateral (ML) footprint of 12mm x 14mm, and range in height from 9mm to 20mm. Each new size is available in a 0 degree and 4 degree angle.

AI/ML Overview

The provided text describes a Special 510(k) submission for a line extension to a spinal implant system called the AVS™ ASL PEEK Spacer System. This submission is for new sizes of an existing device, and the focus of the documentation is to demonstrate substantial equivalence to its predicate device rather than to conduct a de novo clinical study to establish performance against specific acceptance criteria.

Therefore, the document does not contain specific acceptance criteria, reported device performance metrics in the way one would see for a diagnostic or AI-based device, or details about a study designed to prove the device meets such criteria. Instead, the "study" referred to is the submission itself, which primarily relies on technological comparison and engineering testing to demonstrate equivalence.

Here's a breakdown of why many of your requested points are not applicable or cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance
- Not applicable/Not present. The document focuses on demonstrating substantial equivalence of new sizes to an already cleared predicate device. It doesn't present a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that are typically associated with diagnostic devices, nor does it report specific performance outcomes in that manner. Instead, the "acceptance" is based on meeting the criteria for substantial equivalence, which is assessed through material, design, and indications for use comparisons, and compliance with general spinal system guidance.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not present. This refers to a medical device, specifically a spinal implant. There is no "test set" of patient data in the context of diagnostic performance. The document mentions "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed," but these are typically mechanical, biomechanical, and material property tests on the device itself, not tests on patient outcomes data. Thus, there is no sample size of patients or data provenance to report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not present. As this is not a diagnostic device, there is no "ground truth" established by experts in the context of interpreting medical images or clinical outcomes from a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. See point 3.
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/Not present. This device is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not present. This is not an algorithm or software device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not present. For a physical implant, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical performance. These are established through engineering standards, material testing, and preclinical studies, not typically through expert consensus on clinical cases in the way that would apply to diagnostic tools.
The sample size for the training set
- Not applicable/Not present. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established
- Not applicable/Not present. See point 8.

Summary of the Study and "Acceptance Criteria" from the Provided Text:

The "study" in this context is the Special 510(k) submission K061836 for a line extension to the AVS™ ASL PEEK Spacer System.

Objective: To demonstrate substantial equivalence of sixteen new sizes of the AVSTM ASL PEEK Spacer to its legally marketed predicate device (K051205).
"Acceptance Criteria" (Implicit for Substantial Equivalence):
- Material Equivalence: The new sizes must use the same material (PEEK) as the predicate.
- Design Equivalence: The fundamental design principles and features (e.g., Anterior/Posterior and Medial/Lateral footprint) must be similar, with the primary difference being size variation (heights from 9mm to 20mm, 0-degree and 4-degree angles).
- Indications for Use Equivalence: The intended use (vertebral body replacement in the thoraco-lumbar spine (T1-L5) due to tumor or trauma, for anterior decompression and height restoration, with bone graft and supplemental fixation) must be identical to the predicate.
- Performance Equivalence: Testing, implicitly mechanical and biomechanical, must demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004, ensuring the new sizes perform comparably to the predicate in terms of safety and effectiveness.
"Reported Device Performance": The document states: "Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate device in terms of its material, design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVSTM ASL PEEK Spacer." This statement itself is the reported "performance" in the context of a 510(k) for a line extension – that it met the criteria for substantial equivalence.

In conclusion, for this specific type of device and submission, the detailed criteria regarding clinical performance, expert ground truth, and reader studies are not applicable. The primary "acceptance criterion" is the demonstration of substantial equivalence to a predicate device through material, design, and functional comparisons, supported by engineering tests rather than clinical data analysis.

Summary

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Special 510(k) Premarket Noti

AUG 0 3 2006

Special 510(k) Summary of Safety and Effectiveness: Line Extension to the AVSTM ASL PEEK Spacer System

AVSTM ASL PEEK Spacer System Proprietary Name: Common Name: Vertebral Body Replacement Proposed Regulatory Class: Class II Spinal Vertebral Body Replacement Device 21 CFR 888.3060 Device Product Code: MOP For Information contact: Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401 Telephone: (201) 760-8145 Fax: (201) 760-8345 Email: Simona. Voic@stryker.com Date Summary Prepared: June 28, 2006 Stryker Spine AVSTM ASL PEEK Spacer Predicate Device: (K051205)

Description of Device Modification:

Intended Use:

It is recommended to pack bone graft material inside the implant.

The Stryker Spine AVS™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine

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AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Summary of the Technological Characteristics:

Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate device in terms of its material, design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVSTM ASL PEEK Spacer.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services. The department's name is inscribed in a circular pattern around the symbol, reading "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 3 2006

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

Re: K061836

Trade/Device Name: AVS™ ASL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: June 27, 2006 Received: July 11, 2006

Dear Ms. Voic:

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 vour 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 svstems (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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Herbert Weiner us

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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Indications for Use

510(k) Number (if known):

Device Name: Line Extension to the AVS™ ASL PEEK Spacer System

Indications for Use:

The Stryker Spine AVS™ ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Leuner

(Division Division of General, Restorative, and Neurological Devices

Page of of a

510(K) Number K061836

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.