The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Stainless Steel System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Stainless Steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Device Description

The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.

AI/ML Overview

This document is a 510(k) summary for a line extension to the Xia Stainless Steel System, a spinal fixation appliance. It explicitly states that the submission is for "a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors."

This means the device in question is a mechanical component, and the regulatory approval process for such devices typically relies on mechanical testing to demonstrate performance and substantial equivalence to a predicate device, rather than clinical studies involving human or even observational data.

Therefore, the requested information regarding acceptance criteria and studies would primarily focus on the results of mechanical testing. The document does support this by stating: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."

However, the provided text does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria, such as numerical thresholds, sample sizes, or a detailed breakdown of the mechanical tests performed and their results. It only makes a general statement about comparable mechanical properties.

Given the information provided, I cannot populate the requested table or sections related to a study with specific data as it is not present in the document.

Based on the provided text, here's what can be inferred and what cannot:

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

Acceptance Criteria: Not explicitly stated with numerical values. It would likely relate to mechanical properties such as strength, fatigue life, and corrosion resistance, benchmarked against the predicate device.
Reported Device Performance: Not explicitly stated with numerical values. The text only mentions "comparable mechanical properties to the predicate device."

Acceptance Criteria (Inferred from device type)	Reported Device Performance (Inferred from statement)
Mechanical properties comparable to predicate device (e.g., strength, fatigue, corrosion resistance).	"Comparable mechanical properties to the predicate device."

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

Sample Size: Not specified. For mechanical testing, this would refer to the number of components tested for each property.
Data Provenance: Not specified. It can be assumed to be from a laboratory setting as part of product development and regulatory submission, typically conducted by the manufacturer or contracted labs.

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

Not applicable for a mechanical device. Ground truth for mechanical testing is established by material and engineering standards, not expert consensus in the medical diagnostic sense.

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

Not applicable for a mechanical device. This pertains to clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined engineering standards.

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:

Not applicable. This type of study is relevant for AI or diagnostic imaging devices, not for mechanical spinal implants.

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

Not applicable. This refers to AI algorithm performance.

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

For mechanical devices, the "ground truth" often refers to established engineering standards, material specifications, and the performance of the predicate device under specific test conditions. The document implies comparison to these without detailing them.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. This term is used for machine learning.

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

Not applicable. As above, no training set.

In summary: The provided 510(k) summary is for a mechanical device (spinal implant components). It relies on demonstrating "comparable mechanical properties to the predicate device" through mechanical testing for substantial equivalence. However, it lacks the detailed quantitative results and specific acceptance criteria typically found in detailed test reports or studies. The questions provided are largely tailored for diagnostic or AI-driven medical devices, which operate under a different type of evaluation.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'kos1973' in a slightly stylized or cursive font. The letters 'kos' are followed by the numbers '1973', all written in black ink on a white background.

Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia Stainless Steel System

AUG 1 8 2005

Submission Information
Name and Address of the Sponsorof the 510(k) Submission:	Stryker Spine2 Pearl CourtAllendale, NJ 07401
Contact Person:	Simona VoicRegulatory Affairs Project Manager
Date of Summary Preparation:	July 20, 2005
Device Identification
Proprietary Name:	Xia Stainless Steel System
Common Name:	Spinal Fixation Appliances
Classification Name and Reference:	Spinal Interlaminal Fixation Orthosis,21 CFR §888.3050Spinal Intervertebral Body Fixation Orthosis21 CFR §888.3060Pedicle Screw Spinal System21 CFR §888.3070

Predicate Device Identification

The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs).

Description of Device Modification

This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.

Intended Use:

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pcdicle screw fixation system, the Xia Stainless Steel System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Page 1 of 2

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confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Statement of Technological Comparison:

Statement of I components share the same intended use and basic design concepts as that of the r no bate device: Xia Stainless Steel System (K012870 and K031090). Mechanical testing also demonstrated comparable mechanical properties to the predicate device.

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2005

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

Re: K051973

Trade/Device Name: Xia Stainless Steel System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ, MNH, MNI Dated: July 20, 2005 Received: July 21, 2005

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device w Filtere a Prove 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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to print of the provision 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 r ou may , mers, sportions 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. Simona Voic

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to begin manical equivalence of your device of your device to a legally premitset notincation. The Privating of castion 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 If you desire specific advice for your as 0) 276-0120. Also, please note the regulation entitled, a comati the Office of Comphalled at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Mission of Icrerchee to premainer to premainter the Act from the Division of Small other general information on your responsive 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,

Mark N. Melkerson 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): KOSA73______________________________________________________________________________________________________________________________________________

Device Name: Xia Stainless Steel System

Indications For Use:

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a The Xia Grainless Stock of Stainless Steel System is intended for patients: (a) having pealule serville likelion bytem, the Ala Cla) at the fifth lumbar - first sacral (L5-S1) vertebral joint, severe spondylonomene (on asing autogenous bone graft only; (c) who are having the device (b) who are roosting rasimal sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the Xia Stainless Steel System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an to provide in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence the therelore, impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw viton about an antener steel System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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)

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

Page 1

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_K051833

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.