The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Pseudoarthrosis.
Spondylolysis.
Spondylolisthesis.
Fracture.
Neoplastic disease.
Unsuccessful previous fusion surgery.
Lordotic deformities of the spine.
Idiopathic thoracolumbar or lumbar scoliosis.
Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.

Device Description

The XANTUSTM Anterior Lateral Supplemental Fixation System consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. XANTUSTM Anterior Lateral Supplemental Fixation System anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with XANTUSTM Anterior Lateral Supplemental Fixation System. These components include the ZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK® Spinal System nut. Refer to those package inserts for proper specific instructions for use.

AI/ML Overview

This document describes a medical device, the Medtronic Sofamor Danek XANTUS™ Anterior Lateral Supplemental Fixation System, and its clearance process. However, it does not contain a study that provides specific acceptance criteria for performance metrics or data on how the device meets those criteria, as you've requested for AI/software-based devices.

The clearance outlined in the document (K022070) is based on substantial equivalence to a predicate device (K014267), meaning it was determined to be as safe and effective as a previously cleared device. The "study" mentioned is primarily focused on Functionality & Mechanical testing to demonstrate this equivalence for a physical medical device.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study proving device performance in the context of an AI/software device. The document pertains to a physical implantable device.

If this were a software/AI-based device and such a study were present, here's how I would interpret and populate the requested information based on your prompt's structure:

Based on the provided text, the device is a physical implant (XANTUS™ Anterior Lateral Supplemental Fixation System), not an AI/software device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/software performance (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or provided in this regulatory submission.

The document states that demonstrating substantial equivalence to an already cleared predicate device (K014267) is the primary "acceptance criterion" for this type of physical device's regulatory clearance.

Here's what the document does provide regarding "acceptance criteria" and "device performance" in the context of a physical device:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Device Description Match: Be substantially similar in components, configuration, and use as the predicate device.	The XANTUS™ Anterior Lateral Supplemental Fixation System consists of "variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets." It's stated that "Implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with XANTUS™ Anterior Lateral Supplemental Fixation System." This description is implicitly deemed substantially similar to the predicate for regulatory purposes.
Intended Use Match: Have the same intended use as the predicate device.	The intended use is "for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible." This is deemed substantially equivalent to the predicate's intended use.
Indications for Use Match: Have the same indications for use as the predicate device.	Specific indications are listed, including Degenerative Disc Disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Fracture, Neoplastic disease, Unsuccessful previous fusion surgery, Lordotic deformities of the spine, Idiopathic thoracolumbar or lumbar scoliosis, Deformity associated with deficient posterior elements, and Neuromuscular deformity associated with pelvic obliquity. These indications are deemed substantially equivalent to the predicate's indications.
Safety and Functionality (Mechanical Testing): "Functionality & Mechanical testing" must demonstrate substantial equivalence to the predicate device in terms of safety and performance for its intended use.	"Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System." The specific metrics, thresholds, or detailed results of this mechanical testing are NOT provided in this summary document, only the conclusion of substantial equivalence. The system is designed to "provide temporary stabilization until a solid spinal fusion develops."

Sample sizes used for the test set and the data provenance: Not applicable or provided for an AI/software study. The "test set" here refers to the physical samples subjected to mechanical testing. No details on the number of devices or components tested are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device's mechanical testing in this context. Substantial equivalence for mechanical testing is typically based on engineering standards and comparative data, not expert consensus on ground truth in a clinical imaging sense.
Adjudication method: Not applicable for mechanical testing as described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not relevant for the clearance of a physical orthopedic implant system based on substantial equivalence and mechanical testing.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, not applicable.
The type of ground truth used: Not applicable in the context of AI/software. For mechanical testing, the "ground truth" would be established engineering standards, material properties, and performance benchmarks, against which the measured functionality of the device is compared.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K022070 1/2

JUL 2 2 2002

Medtronic Sofamor Danek XANTUS™Anterior Lateral Supplemental Fixation System 510(k) Summary June 2002

Submitter:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132
Contact Person:	Richard Treharne
Trade Name:	XANTUSTM Anterior Lateral Supplemental Fixation System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis, Class II
Predicate Device(s):	The XANTUSTM Anterior Lateral Supplemental Fixation Systemis substantially equivalent to K014267, Medtronic Sofamor DanekXANTUSTM Anterior Lateral Supplemental Fixation System, which wascleared on January 25, 2002.
Device Description:	The XANTUSTM Anterior Lateral Supplemental Fixation System consists of avariety of shapes and sizes of plates, screws, bolts, and nuts, as well asancillary products and instrument sets. XANTUSTM Anterior LateralSupplemental Fixation System anterior implant components can be locked intoa variety of configurations, with each construct being tailor-made for theindividual case. Implant components from other previously cleared MedtronicSofamor Danek Spinal Systems can be used in conjunction with XANTUSTMAnterior Lateral Supplemental Fixation System. These components include theZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK®Spinal System nut. Refer to those package inserts for proper specificinstructions for use.
Intended Use:

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

00036

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Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. Unsuccessful previous fusion surgery. 7. 8. Lordotic deformities of the spine. Idiopathic thoracolumbar or lumbar scoliosis. 9. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with 10. deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) 11. associated with pelvic obliquity. Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Safety Testing: Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System. The XANTUS™ Anterior Lateral Supplemental Fixation System is Conclusion: substantially equivalent to K014267, the XANTUSTM Anterior Lateral Supplemental Fixation System .

KO22070p%

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing right, with flowing lines above them that resemble wings or ribbons.

JUL 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

K022070 Re:

Trade/Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System Regulatory Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP, MNH Dated: June 18, 2002 Received: June 26, 2002

Dear Dr. Treharne:

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 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 –

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

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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K622670 510(k) Number (if known): _

Device Name: XANTUS™ Anterior Lateral Supplemental Fixation System

Indications for Use:

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration 1. of the disc confirmed by history and radiographic studies).
1. Pseudoarthrosis.
1. Spondylolysis.
1. Spondylolisthesis.
న. Fracture.
1. Neoplastic disease.
1. Unsuccessful previous fusion surgery.
1. Lordotic deformities of the spine.
1. Idiopathic thoracolumbar or lumbar scoliosis.
1. Deformity (i.e., scoliosis, lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
1. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.

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

Concurrence of CDRH, Office of Evaluation (ODE)

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

510(k) Number K022070 K022070

Prescription Use OR Over-the-counter Use
(Per 21 CFR 801.109)
(Optional 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.