The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar 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 Spinal System and Xia Stainless Steel Systems are 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, kyphosis, 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 Spinal System and Xia Stainless Steel Systems are 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.

Device Description

This submission is intended to address a line extension to both the Xia Spinal System and the Xia Stainless Steel System. The line extension includes a Dual Staple and modified cross connectors. The new components will be used for anterior fixation.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System and Xia Stainless Steel System. This regulatory submission is for medical devices, specifically spinal fixation appliances. For such devices, acceptance criteria and performance are typically demonstrated through mechanical testing and comparison to a predicate device, rather than clinical studies involving human patients, especially for line extensions that introduce minor modifications.

Therefore, many of the typical questions asked for AI/software-based medical devices regarding clinical study design are not applicable here.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Comparable mechanical properties to predicate devices	Mechanical testing demonstrated comparable mechanical properties to the predicate devices.

Explanation: The primary acceptance criterion for this line extension, which includes new components (Dual Staple and modified cross connectors), is to demonstrate mechanical equivalence to the existing predicate Xia Spinal System and Xia Stainless Steel System.

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

Not applicable in the context of this device and submission type. The "test set" here refers to the new components (Dual Staple and modified cross connectors) and their mechanical performance. The "data provenance" would relate to the specific mechanical testing methods and standards used, but this level of detail is not provided in the summary.

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

Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for subjective clinical assessments, not objective mechanical tests.

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 is a hardware medical device (spinal fixation system), not an AI/software device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is the mechanical performance of the predicate devices as established through engineering testing. The new components must demonstrate mechanical properties comparable to these established devices.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning model.

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

Not applicable. This is a hardware medical device, not a machine learning model.

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

The study proving the device meets the acceptance criteria is a mechanical testing study. The summary states:

"Mechanical testing demonstrated comparable mechanical properties to the predicate devices."

This indicates that the new components (Dual Staple and modified cross connectors) underwent a series of standardized mechanical tests designed to assess their strength, durability, and other relevant physical characteristics. The results of these tests were then compared against the established mechanical performance data of the predicate Xia Spinal System and Xia Stainless Steel System components. By demonstrating "comparable mechanical properties," the manufacturer has shown that the new components are mechanically equivalent to the already approved devices, thus meeting the acceptance criteria for this line extension. The specific details of these mechanical tests (e.g., types of tests, number of samples, test parameters, specific standards followed) are not provided in this summary but would have been part of the full 510(k) submission.

Summary

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Line Extension to the Nia Spinal System and the Xia Stainless Steel System

Special 510(k) Premarket Notification

'JUL 1 7 2003

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

Proprietary Name:	Xia Spinal System and Xia Stainless Steel System
Common Name:	Spinal Fixation Appliances
Proposed Regulatory Class:	Class IISpinal Interlaminal Fixation Orthosis, 21 CFR 888.3050Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060Pedicle Screw Spinal System, 21 CFR 888.3070
Device Product Code:	87 KWP: Appliance, Fixation, Spinal Interlaminal
	87 KWQ: Appliance, Fixation, Spinal, Intervertebral Body
	87 MNH: Spondylolisthesis Spinal Fixation System
	87 MNI: Orthosis, Spinal, Pedicle Fixation
For Information contact:	Karen Ariemma
	Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, NJ 07401-1677
	Telephone: (201) 831-5718
	Fax: (201) 831-6038
	Email: kariemma@howost.com
Date Summary Prepared:	May 30, 2003

Predicate Device Identification

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

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

Description of Device Modification

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Special 510(k) Premarket Notification

Intended Use:

031893
page 2 of 2

Statement of Technological Comparison:

The subject components share the same intended use and basic design concepts as that of the predicate device. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K031893

Trade/Device Name: Xia Spinal System and Xia Stainless Steel System Regulation Number: 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, KWQ,MNI, MNH Dated: June 17, 2003 Received: June 19, 2003

Dear Ms. Ariemma:

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. Karen Ariemma

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours.

Sincerely, yours,

Mark N. Mulkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 03 189 7

Device Name: Xia Spinal System and Xia Stainless Steel System

The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (LS-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 Spinal 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, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the Xia Spinal 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 deformities such as scoliosis, kyphosis, lordosis, turnor, pseudoarthrosis or revision of failed fusion attempts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark N. Milburn
for Division of Oil

Division Sion-Division of General, Restorative and Neurological Devices

510(k) Number K031813

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510(k) Number (if known): K 0 31893

The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine 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 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, kyphosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Mark N. Milliken

Division of General, Restorative and Neurological Devices

510(k) Number K031893

Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.