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; (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 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 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.

Device Description

The submission involves no change to the components themselves. This submission covers use of predicate OSS and Opus 6 mm diameter Rods with the predicate Xia Spinal System.

AI/ML Overview

This 510(k) submission (K013688) focuses on allowing the use of previously cleared Osteonics® Spinal System (OSS) and Opus Spinal System rods with the Xia Spinal System. It does not describe a study involving an "AI device" or "algorithm" in the conventional sense of machine learning or diagnostic imaging. Instead, the "device" in question is a medical implant (spinal fixation system components). Therefore, acceptance criteria and study details related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of human readers with/without AI) are not applicable here.

However, I can extract the relevant information regarding the mechanical performance study conducted to demonstrate the safety and effectiveness of using these combined components, which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's the information structured to best fit your request, adapting the columns where necessary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Objective)	Reported Device Performance (Conclusion)
Comparable mechanical properties	Construct fatigue testing demonstrates comparable mechanical properties of the subject Xia Spinal System with Ti-6A1-4V alloy (Opus or OSS) Rods to other predicate constructs.

Study Details (Mechanical Testing)

Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The description refers to "Construct fatigue testing," implying multiple test specimens were subjected to fatigue loads. Data provenance is not applicable in the human subject or imaging sense; this is a laboratory-based mechanical test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized testing protocols (e.g., ASTM standards for fatigue testing of medical implants) and measured physical properties by engineers. No human expert "ground truth" establishment in the diagnostic sense is mentioned.
Adjudication method for the test set: Not applicable. This is mechanical testing, not a clinical review of images or data requiring adjudication among experts.
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 submission for a physical medical device (spinal implant components), not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm involved. "Standalone" performance here refers to the mechanical integrity of the device itself.
The type of ground truth used: For mechanical properties, the "ground truth" is typically defined by established engineering standards and material specifications that define acceptable performance limits (e.g., fatigue life, stiffness, strength) for spinal implants. The comparison is against predicate constructs (existing, legally marketed spinal systems). The phrase "comparable mechanical properties" indicates the tested construct's performance met or exceeded the performance of the predicate devices.
The sample size for the training set: Not applicable. This is a mechanical test for a physical device, not an AI or machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable, as no training set exists for this type of submission.

Summary

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0136888

Special 510(k) Summary of Safety and Effectiveness: DEC 0 5 2001 OSS and Opus Rods - Use with Xia Spinal System

Submission Information

Howmedica Osteonics Corp Name and Address of the Sponsor of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 Contact Person: Karen Ariemma Regulatory Affairs Specialist November 6, 2001 Date of Summary Preparation: Device Identification Xia Spinal System Proprietary Name: Common Name:

Spinal Fixation Appliances Classification Name and Reference: Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050 Spinal Intervertebral Body Fixation Orthosis 21 CFR 888.3060 Pedicle Screw Spinal System 21 CFR 888.3070

Predicate Device Identification

The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K002505. The Rods for the Osteonics® Spinal System (OSS) were determined substantially equivalent via 510(k) K951725. The Rods for the Opus Spinal System were determined substantially equivalent via 510(k) K990922. This submission is intended to allow the use of the predicate OSS and Opus Rods with the predicate Xia Spinal System.

Description of Device Modification

The submission involves no change to the components themselves. This submission covers use of predicate OSS and Opus 6 mm diameter Rods with the predicate Xia Spinal System.

Intended Use:

The Rods from the Osteonics® Spinal System and Opus Spinal System are intended to be used with the components of the Xia Spinal System.

Indications for Use:

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KC513684

Statement of Technological Comparison:

Construct fatigue testing demonstrates comparable mechanical properties of the subject Xia Spinal System with Ti-6A1-4V alloy (Opus or OSS) Rods to other predicate constructs.

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Public Health Service

Image /page/2/Picture/2 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 edge. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Ariemma Howmedica Osteonics Corp. Regulatory Affairs Specialist 59 Route 17 Allendale, New Jersey 07401

DEC 0 5 2001

Re: K013688

Trade Name: Xia Spine System Regulation Number: 21 CFR 888.3050, 888.3060, and 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, and Pedicle screw spinal system. Regulatory Class: II Product Code: MNH, KWP, KWQ, and MNI Dated: November 6, 2001 Received: November 7, 2001

Dear Ms. Ariemma:

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 -- Ms. Karen Ariemma

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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Mark N. Millman

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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510(k) Number (if known): KD43688

Device Name: Xia Spinal System

The 6 mm diameter rods from the Osteonics® Spinal System and Opus Spinal System are intended to be used with the other components of the Xia Spinal System.

Indications For Use:

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; (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 Spine System is also intended to provided 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 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, 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)
for Mark R. Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K013688

510(k) Number

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.