When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass
When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by 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 Cadence Spinal Fixation System are intended for 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 Cadence™ 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 varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.

AI/ML Overview

The Cadence™ Spinal Fixation System is a medical device, and the provided document is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving performance through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm might. Therefore, many of the requested fields about AI-specific study design (e.g., sample size for training/test sets, expert ground truth, MRMC studies, standalone performance) are not applicable or directly addressed in this document.

Here's an analysis based on the provided text, focusing on the evidence presented to support the device's acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from predicate device or established standards)	Reported Device Performance
Mechanical properties (e.g., strength, durability, fatigue resistance as per ASTM F 1717-96 and ASTM F 1798-97)	Demonstrated substantially equivalent mechanical properties to the predicate device (Silhouette™ Spinal Fixation System components).
Biocompatibility (implied, as it uses titanium alloy (Ti-6Al-4V) conforming to ASTM F-136, standard for implants)	Uses titanium alloy (Ti-6Al-4V) conforming to ASTM F-136, which is a recognized standard for implantable materials.
Intended Use (aligned with predicate device)	Intended uses are consistent with the predicate device for various spinal instabilities and deformities, including pedicle screw fixation and hook/sacral screw systems.
Material	Manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated. The study involved mechanical testing of components, not human patient data in the context of this 510(k) summary. The "test set" here refers to the actual physical components tested.
Data Provenance: Not applicable in the context of a clinical test set. The data originates from laboratory mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. Ground truth for mechanical properties is established by adherence to standardized testing protocols (ASTM F 1717-96 and ASTM F 1798-97), not expert consensus on clinical findings.
Qualifications of Experts: Not applicable. The "ground truth" is defined by the physical properties measured according to the ASTM standards.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. Mechanical testing results are objective measurements based on standardized methodologies, not subject to human interpretation requiring adjudication in this context.

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:

MRMC Study: No. This is a spinal fixation system, not an AI or imaging diagnostic device. MRMC studies are not relevant to its evaluation.
Effect Size of AI Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: No. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for the device's performance is based on standardized mechanical performance metrics outlined in ASTM F 1717-96 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F 1798-97 (Standard Guide for Evaluation of Spinal System Constructs in a Vertebrectomy Model). These standards define the expected biomechanical behavior and material characteristics for such devices.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence for a physical medical device. The "training" in manufacturing comes from established engineering principles and quality control processes.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable.

Summary of the Study and How the Device Meets Acceptance Criteria:

The study that proves the Cadence™ Spinal Fixation System meets acceptance criteria is a series of mechanical tests conducted according to established industry standards: ASTM F 1717-96 and ASTM F 1798-97.

The acceptance criteria are implicitly derived from the performance of the predicate device, the Silhouette™ Spinal Fixation System, and the requirements of the ASTM standards themselves. The core acceptance criterion for this 510(k) submission is "substantial equivalence" in mechanical properties to the predicate device.

The study demonstrated that the Cadence™ Spinal Fixation System's components exhibited "substantially equivalent mechanical properties" when compared to the previously cleared Silhouette™ Spinal Fixation System components. This means that the Cadence™ system passed the mechanical tests (likely involving dynamic and static loading, fatigue, and material strength) at levels comparable to, or better than, the predicate device. The use of titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 further supports its material suitability and biocompatibility, aligning with established standards for implantable medical devices.

The FDA's clearance (K022374) confirms that based on this mechanical testing and comparison, the device is considered substantially equivalent to the predicate device for its stated indications for use.

Summary

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SEP 2 4 2002

510(k) Summary

Submitter:	Centerpulse Spine-Tech7375 Bush Lake RoadMinneapolis, Minnesota 55439
Date Prepared:	August 19, 2002
Contact:	Kristyn M. BensonRegulatory Affairs Specialist
Proprietary Name:	Cadence™ Spinal Fixation System
Common Name:	Rod, hook, and screw spinal instrumentation
Device Product Code& Classification:	Class II; MNI, MNH, and KWP
Predicate Device:	Silhouette™ Spinal Fixation System(K980288 & K992276)

Device Description:

Intended Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Cadence Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:

a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only

Cadence™ Spinal Fixation System Special 510(k) Notification

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c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass

When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

Statement of Technological Comparison:

Mechanical testing was carried out according to ASTM F 1717-96 and ASTM F 1798-97 to validate the Cadence™ Spinal Fixation System. The testing demonstrated substantially equivalent mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components.

Cadence™ Spinal Fixation System Special 510(k) Notification

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2002

Ms. Kristyn M. Benson Regulatory Affairs Specialist Centerpulseº - Spine-Tech Division 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027

K022374 Re:

K022374
Trade Name:	Cadence™ Spinal Fixation System
Regulation Number:	21 CFR 888.3070, 21 CFR 888.3050
Regulation Name:	Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis
Regulatory Class:	Class II
Product Code:	MNI, MNH, KWP
Dated:	August 29, 2002
Received:	August 30, 2002

Dear Ms. Benson:

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 – Ms. Kristyn M. Benson

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 you 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/dsmamain.html.

Sincerely yours.

Mach A. Melleman

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 STATEMENT

K022374 510(k) Number:

Cadence™ Spinal Fixation System Device Name:

Indications for Use:

In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:

a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine; and

d) who are having the device removed after the development of a solid fusion mass When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K022374

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter-Use_

Cadence™ Spinal Fixation System Special 510(k) Notification

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.