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, 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 4.5 mm diameter Polyaxial Screws and longer length rods.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a line extension to the Xia Stainless Steel System, a spinal fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it is not a clinical study report.

Here's why the requested information is absent and what the document does provide:

A table of acceptance criteria and the reported device performance:
- Absent. This document doesn't define specific clinical acceptance criteria (e.g., a certain reduction in pain, a specific fusion rate, or a particular performance statistic like sensitivity/specificity for a diagnostic device).
- What is present: The document states that "Mechanical testing demonstrated comparable mechanical properties to the predicate device." This is the basis for demonstrating substantial equivalence for this type of device modification (a line extension with different screw diameters and rod lengths). The acceptance criteria for this would be defined by the mechanical testing standards used (e.g., ASTM standards for spinal implants) comparing the new components to the predicate, demonstrating that they perform similarly or better under defined load conditions. However, the specific results or table of these criteria/performance are not included in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Absent. There is no clinical test set in the context of a prospective or retrospective study for a diagnostic or therapeutic effect. The "test set" here would refer to the samples of the new device components used for mechanical testing. The document does not specify the number of samples used for these mechanical tests.
- What is present: The device itself is manufactured by Howmedica Osteonics Corp based in Allendale, NJ, USA.
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):
- Absent. Ground truth establishment by experts is relevant for diagnostic devices or those with subjective outcome measures. For spinal fixation hardware, the "ground truth" is typically defined by engineering standards for mechanical performance, biocompatibility, and material properties, not by expert medical evaluation of a patient test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Absent. Adjudication methods are used for resolving disagreements in expert ground truth establishment for clinical or diagnostic studies. This is not applicable here.
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:
- Absent. This is a hardware device (spinal implant), not a diagnostic algorithm or AI-assisted system. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Absent. This is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- What is present: For a spinal implant, the "ground truth" for demonstrating safety and effectiveness in a 510(k) submission is typically established through:
  - Mechanical Integrity/Performance: Compliance with recognized ASTM or ISO standards for spinal implants, demonstrating equivalent or superior strength, fatigue life, and other mechanical properties compared to the predicate device.
  - Biocompatibility: Confirmation that the materials (stainless steel) are appropriate for implant use and have known biocompatibility profiles (often addressed by referencing predicate devices or established material standards).
  - Intended Use Compatibility: The new components fit within the intended use of the existing system and predicate.
- The document implies that mechanical testing was the primary evidence for this line extension.
The sample size for the training set:
- Absent. Spinal implants do not have a "training set" in the sense of machine learning algorithms or clinical trials.
How the ground truth for the training set was established:
- Absent. Not applicable.

In summary, the provided document is a regulatory submission for a device modification (line extension) that demonstrates substantial equivalence to a legally marketed predicate device. It primarily relies on design comparison and mechanical testing to establish comparable safety and effectiveness, rather than a clinical study with specific acceptance criteria and detailed performance metrics as would be found for a novel therapeutic or a diagnostic device.

Summary

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APR 2 4 2003

Special 510(k) Premarket Notification

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

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Karen AriemmaRegulatory Affairs Specialist
Date of Summary Preparation:	April 4, 2003
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, 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 4.5 mm diameter Polyaxial Screws and longer length rods.

Intended Use:

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Image /page/1/Picture/1 description: The image shows the text "KO31090 P2/2" in a handwritten-like font. Below this, the text "Special 510(k) Premarket Notification" is printed in a formal font. The text at the top appears to be a reference or code, while the text at the bottom indicates the document's purpose.

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:

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 device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K031090

Trade/Device Name: XIA Stainless Steel System Regulatory 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: April 4, 2003 Received: April 7, 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. Iisting 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

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Page 2 - Ms. Karen Ariemma

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4639. 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,

Miriam C. Provost

tos 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): K031090

Device Name: Xia Stainless Steel System

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

Muriam C. Provost

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

510(k) Number K031090

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.