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 (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™ 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 neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (psuedoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal 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, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.

Device Description

The Xia™ Spinal System C-C Adaptor is a line extension to the Xia™ Spinal System. It consists of a C-C Adaptor with a set screw. The Xia™ Spinal System C-C Adaptor is a lateral connector. When used with a Xia™ Spinal System I-Connector, it allows for attachment of a hook to the longitudinal rod. The components are manufactured from titanium alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Xia™ Spinal System C-C Adaptor. This notification focuses on demonstrating substantial equivalence to a predicate device through information on intended use, materials, design, operational principles, and mechanical testing.

However, the document does not contain information about:

A table of acceptance criteria and reported device performance in the context of clinical or diagnostic accuracy. The "performance" mentioned is limited to meeting mechanical functional requirements.
Sample sizes for test sets (clinical performance), data provenance.
Number of experts used or their qualifications for establishing ground truth for a test set.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies.
Type of ground truth used (clinical/diagnostic).
Sample size for training sets.
How ground truth for training sets was established.

Instead, the submission relies on mechanical testing results and substantial equivalence to a predicate device for market clearance.

Here's a breakdown of what is provided and what is missing for your request:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Mentioned: The document states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." This implies that predefined mechanical performance criteria exist, but the specific values or thresholds are not detailed in this summary.
Reported Device Performance: The summary explicitly states, "Mechanical testing demonstrates that the device will meet the mechanical functional requirements." However, the actual test results (e.g., specific load capacities, fatigue cycles, etc.) are not provided. This is a summary and likely refers to detailed test reports submitted separately to the FDA.

Acceptance Criteria (Type)	Reported Device Performance
Mechanical functional requirements	Meets mechanical functional requirements (specifics not detailed in this summary)

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

The document describes mechanical testing, not clinical performance studies involving a test set of patient data. Therefore, this information is not applicable/provided in the context of clinical or diagnostic accuracy.
For mechanical testing, the "sample size" would refer to the number of devices or components tested. This is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable as it's mechanical testing, not clinical data.

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

This information is not applicable/provided as the study described is mechanical testing, not a study requiring expert clinical interpretation for ground truth.

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

This information is not applicable/provided as the study described is mechanical testing.

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:

This information is not applicable/provided. The device is a spinal implant component, not an AI-powered diagnostic tool.

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

This information is not applicable/provided. The device is a spinal implant component, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be established by engineering standards and validated physical measurements using calibrated equipment. This is implied but not explicitly detailed as "ground truth" in the clinical sense.

8. The sample size for the training set:

This information is not applicable/provided. The device is not an AI algorithm requiring a training set.

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

This information is not applicable/provided. The device is not an AI algorithm.

Summary of the Study:

The study described for the Xia™ Spinal System C-C Adaptor is mechanical testing.

Purpose: To demonstrate that the device meets mechanical functional requirements and supports substantial equivalence to the predicate Xia™ Spinal System L-Connector.
Methodology: Mechanical testing was performed. Although the details of the specific tests (e.g., fatigue, static compression, torsional strength) and the number of samples are not provided in this summary, such tests are standard for spinal fixation devices.
Outcome: The testing "demonstrates that the device will meet the mechanical functional requirements." This indicates a successful outcome in meeting predefined engineering performance standards.
Reliance for 510(k) Clearance: The clearance is primarily based on equivalence in intended use, materials, design, and operational principles to the predicate, supported by these positive mechanical test results. The 510(k) process for devices like this typically relies heavily on non-clinical (mechanical, materials, biocompatibility) testing rather than human clinical trials or AI performance evaluations.

Summary

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NOV 1 6 1999

Xia™ Spinal System C-C Adaptor

1992792

510(k) Premarket Notification

510k Summary

Device:	Xia™ Spinal System C-C Adaptor
Common name:	Spinal Fixation Device
Classification Name:	Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050
	Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060
	Pedicle Screw Spinal System, 21 CFR 888.7070
Regulatory Class:	Class II
Product Code:	87 KWP, 87KWQ, 87MNH AND 87MNI
Contact Person:	Karen Ariemma, Regulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, New Jersey 07401-1677phone (201) 760-8187fax (201) 934-4368

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510(k) Premarket Notification

The substantial equivalence of this device is based on an equivalence in intended use, materials, design and operational principles to the predicate Xia™ Spinal System L-Connector. Mechanical testing demonstrates that the device will meet the mechanical functional requirements.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of three human profiles facing right, with three curved lines above them, resembling a stylized bird or wing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Ms. Elizabeth A. Staub Vice President, Quality Assurance, Regulatory Affairs, Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K992792 Re: Howmedica Osteonics® XIA™ Spinal System Trade Name: Requlatory Class: II Product Codes: KWQ, KWP, MNH, and MNI Dated: August 17, 1999 Received: August 19, 1999

Dear Ms. Staub:

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 The general controls provisions of the Act 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. ਜੋ 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 - Ms. Elizabeth A. Staub

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 the regulation entifical "Hibbranding by 1015. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 942 792

Device Name: Howmedica Osteonics® Xia™ Spinal System C-C Adaptor

The subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are singleuse devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System.

When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal 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, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Us

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992792

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.