XIA SPINE SYSTEM by HOWMEDICA, INC.

The XIA Spine 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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

When used as a pedicle screw fixation system, the XIA Spine 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 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 Spine System is indicated for patients with degenerative disc disease of the thoracic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

Device Description

The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.

AI/ML Overview

The provided text describes a 510(k) summary for the XIA Spine System. It focuses on the device's indications for use and its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it is a regulatory submission for premarket notification (510(k)) and not a study report.

Here's what can be extracted based on the information given:

Acceptance Criteria and Device Performance (Based on the 510(k) Summary)

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Functional Requirements for Spinal Fixation Devices (as assessed by bench testing)	"Bench testing demonstrates that the device will meet its mechanical functional requirements."
Substantial Equivalence in Intended Use to legally marketed predicate devices	The device's intended use is described as spinal fixation for various conditions in the noncervical spine, including pedicle screw fixation (for severe spondylolisthesis, acute/chronic instabilities, deformities, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion) and anterior/posterior screw/hook fixation (for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, spinal deformities, tumor, pseudoarthrosis, revision of failed fusion). This is explicitly stated to be equivalent to predicate devices.
Substantial Equivalence in Materials to legally marketed predicate devices	The XIA Spine System components are manufactured from titanium, which is stated to be substantially equivalent to predicate devices.
Substantial Equivalence in Designs to legally marketed predicate devices	The system consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. These design characteristics are stated to be substantially equivalent to predicate devices.
Substantial Equivalence in Operational Principles to legally marketed predicate devices	The operational principle (spinal fixation) is stated to be substantially equivalent to predicate devices.
Compliance with general controls provisions of the Act (e.g., annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration)	The FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." It also notes that a "substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions."

Missing Information from the Provided Text:

Sample size used for the test set and the data provenance: Not applicable. The submission refers to "bench testing," not a clinical test set with patient data. No details about the number of devices or iterations tested are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing doesn't typically involve human experts establishing ground truth in this manner.
Adjudication method for the test set: Not applicable.
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 not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
The type of ground truth used: For the "bench testing," the ground truth would be the pre-defined mechanical functional requirements or engineering specifications that the device needed to meet.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to pre-existing devices through comparisons of intended use, materials, designs, operational principles, and bench testing to meet mechanical requirements. It does not describe a clinical study with patients that would typically involve many of the detailed inquiries above, especially those related to AI or clinical effectiveness.

Summary

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K98425)

510(k) Summary

XIA SPINE SYSTEM

Common Name: Classification Name:

(888.3060)

Device:

Requlatory Class: Product Code:

Spinal Fixation Device Spinal Interlaminal Fixation Orthosis (888.3050) Spinal Intervertebral Body Fixation Orthosis

Pedicle Screw Spinal System (888.7070) Class II 87KWP, 87KWQ, 87MNH and 87MNI

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7830 Fax: (201) 507-6870

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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.

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When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease of the thoricic, lumbar, 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. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.

The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to other predicate devices indicated for noncervical spinal fixation. These devices include Howmedica's BWM Spine System, Synthes® Spine's Universal Spinal System (USS) and the MOSS Miami Spinal System by DePuy. Bench testing demonstrates that the device will meet it mechanical functional requirements.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

K984251

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re:

Trade Name: XIA Spine System Regulatory Class: II Product Codes: KWP, KWQ, MNH, and MNI Dated: November 25, 1998 Received: November 27, 1998

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. John F. Dichiara

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K98425 |

Device Name:

XIA SPINE SYSTEM

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use ______
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K984251

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.