The ST360™ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a hook and sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Description

The ST360™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varving diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various configurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

AI/ML Overview

This appears to be a 510(k) Summary for a medical device called the ST360™ Spinal Fixation System, not a study evaluating its performance against acceptance criteria in the way described by the request. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, rather than a prospective study demonstrating specific performance metrics.

Therefore, most of the requested information cannot be extracted from the provided text because it describes a different type of evaluation.

However, I can provide what is available, noting the differences:

The "study" cited is a mechanical testing comparison to demonstrate substantial equivalence, not a clinical performance study with human subjects, expert adjudication, or AI components.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and where the requested information is absent:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the format of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity for an AI device). The document states:
- Acceptance Criteria (Implied): Substantial equivalence in mechanical properties to predicate devices (Silhouette™ Spinal Fixation System and previous ST360™ components) as measured by ASTM F 1717 and ASTM F 1798.
- Reported Device Performance: "The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System and ST360™ Spinal Fixation System components." No specific numerical performance values are given.
Sample size used for the test set and the data provenance:
- Sample Size: Not specified (refers to mechanical test samples, not clinical data).
- Data Provenance: N/A (mechanical testing, not clinical data from countries). The text implies laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is mechanical testing outcomes, not expert medical opinion.
Adjudication method for the test set: Not applicable. This is for clinical or AI performance, not mechanical testing.
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 document describes a spinal fixation system, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used: Mechanical properties measured according to ASTM F 1717 and ASTM F 1798 standards, demonstrating equivalence to predicate devices.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) Summary for a spinal implant system, focusing on its regulatory clearance based on substantial equivalence demonstrated through mechanical testing. It does not provide the kind of performance data, clinical study details, or AI-specific information requested in the prompt.

Summary

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510(k) Summary

Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, Minnesota 55439
Date Prepared:	July 15, 2004
Contact:	Kristin JansManager, Regulatory Affairs
Proprietary Name:	ST360™ Spinal Fixation System
Common Name:	Rod, hook, and screw spinal instrumentation
Device Product Code& Classification:	Class III; MNI, MNH, KWP, NKB
Predicate Device:	ST360™ Spinal Fixation System (formerly Cadence)(K022374)

Device Description:

Intended Use:

The ST360 ™ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

Statement of Technological Comparison:

Mechanical testing was carried out according to ASTM F 1717 and ASTM F 1798 to validate the modifications to the ST360™ Spinal Fixation System. The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System and ST360™ Spinal Fixation System components.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2008

Zimmer Spine, Inc. c/o Mr. Tim Crabtree Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, MN 55439

Re: K041925

Trade/Device Name: ST360™ Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; pedicle screw spinal system Regulatory Class: Class III Product Code: KWP, MNH, MNI, NKB Dated: September 24, 2004 Received: September 24, 2004

Dear Mr. Crabtree:

This letter corrects our substantially equivalent letter of September 24, 2004.

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 (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, 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 (PMA), it may be subject to 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

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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.

This letter will allow you to continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K041925

Device Name: ST360°® Spinal Fixation System

Indications for Use:

The ST360° Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Youbare Buelid for mym
Division Sign Off

Division of General, Restorative, and Neurological Devices

ST360 Spinal Fixation System K041925

Page 1 of 3

510(k) Number.

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510(k) Summary

Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439
Date Prepared:	August 30, 2007
Contact:	Tim CrabtreeSenior Regulatory Affairs Specialist
Device Name:	Trade Name: ST360°® Spinal Fixation SystemCommon Name: Rod, hook, and screw spinal instrumentation
Classification:	Class III
Product Codes:	NKB, MNI, MNH, KWP
Predicate Device:	ST360°® Spinal Fixation System (K022374, K041925)

Device Description:

The ST360® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polvaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varving lengths, hooks in varying designs, fixed and adjustable transverse connectors, The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ASTM F-136.

Intended Use:

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Statement of Technological Comparison:

There are no changes to the material of construction or the mechanism of action to the ST360° Spinal Fixation System. The modified system has the same fundamental scientific technology and intended use and indications as the predicate device.

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.