When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ 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 Silhouette™ Spinal Fixation System is indicated for use in patients:

having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
who are receiving fusions with autogenous graft only
who are having the device fixed or attached to the lumbar or sacral spine, and
who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette™ 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 Silhouette™ 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 Silhouette™ 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. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sulzer Spine-Tech Silhouette™ Spinal Fixation System, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Modification	Test Performed	Acceptance Criteria	Test Results
Addition of Adjustable Transverse Connector	Fatigue Testing of Silhouette™ Spinal Fixation System/adjustable transverse connector construct per ASTM Provisional Standard PS 5-94, Test Method for Static and Dynamic Spinal Implant Assembly in a Corpectomy Model	No Failures 156 N run-out load 5,000,000 cycles	Passed

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

The document does not explicitly state the sample size for the test set. It mentions "Fatigue Testing of Silhouette™ Spinal Fixation System/adjustable transverse connector construct." The data provenance is not specified beyond being generated by Sulzer Spine-Tech for regulatory submission. It is a non-clinical, in-vitro test.

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

This information is not applicable. The study is a non-clinical, in-vitro device performance test against a predefined engineering standard (ASTM Provisional Standard PS 5-94), not a clinical study involving expert interpretation of data or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically relevant for clinical studies where there may be disagreements among human reviewers. This was a physical performance test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical engineering performance testing of a spinal fixation system.

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

Yes, in a sense, a "standalone" test was performed. The device, specifically the adjustable transverse connector and the system construct, was subjected to a standalone physical performance test without human involvement in its operation or interpretation during the test itself. The test was to evaluate the physical properties of the device against an established standard.

7. The Type of Ground Truth Used

The ground truth used was based on an established engineering standard: ASTM Provisional Standard PS 5-94, Test Method for Static and Dynamic Spinal Implant Assembly in a Corpectomy Model. The acceptance criteria (no failures, 156 N run-out load, 5,000,000 cycles) are derived directly from this standard.

8. The Sample Size for the Training Set

This information is not applicable. This document describes performance testing of a physical medical device, not an AI/ML algorithm that would require a training set.

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/3 description: The image shows the words "SULZER MEDICA" in a bold, sans-serif font. The text is black and appears to be a logo or brand name. The words are arranged horizontally, with "SULZER" above "MEDICA".

NOV 1 6 1999

1.493067

Sulzer Spine-Tech

7375 Bush Lake Road Minneapolis, MN 55439-2027

Phone 612-832-5600 612-832-5620 Fax

510(k) Summary

A.	Submitters' Information
	Date:	November 15, 1999
	Name/Address:	Sulzer Spine-Tech7375 Bush Lake RoadMinneapolis, Minnesota 55439
	Telephone Number:Fax Number:	(612) 830-6205(612) 832-5620
	Contact:	Janell A. ColleyRegulatory Affairs Specialist
B.	Device Information
	Trade Name:	Silhouette™ Spinal Fixation System
	Common Name:	Rod, hook, and screw spinalinstrumentation
	Classification:	Class II, KWP, MNI, and MNH
	Predicate Device:	Silhouette™ Spinal Fixation SystemK992276(concurrence date October 1, 1999)

Device Description:

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Intended Use:

When used as a pedicle screw fixation system in skeletally mature patients, the 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 Silhouette™ Spinal Fixation System is indicated for use in patients:

having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ೩) joint
who are receiving fusions with autogenous graft only b)
who are having the device fixed or attached to the lumbar or c) sacral spine, and
d) who are having the device removed after the development of a solid fusion mass

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C. Comparison of Required Technological Characteristics

The modified Silhouette™ Spinal Fixation System is substantially equivalent to the predicate Silhouette™ Spinal Fixation System. The table below provides a comparison of equivalency characteristics.

Characteristics	Equivalency
Intended Use	Identical
Anatomical Sites	Identical
Target Population	Identical
Sterilization	Identical
Packaging	Identical
Operating Principle	Identical
Materials	Identical
Labeling	Substantially Equivalent
Physical Characteristics (Design)	Substantially Equivalent
Performance Testing	Substantially Equivalent
Safety Characteristics	Substantially Equivalent

D. Summary of Non-Clinical Tests

The following is a summary of the testing performed on the modified Silhouette™ Spinal Fixation System:

Modification	Test Performed	AcceptanceCriteria	Test Results
Addition ofAdjustableTransverseConnector	Fatigue Testing of Silhouette™Spinal FixationSystem/adjustable transverseconnector construct per ASTMProvisional Standard PS 5-94,Test Method for Static andDynamic Spinal ImplantAssembly in a CorpectomyModel	No Failures156 N run-outload5,000,000 cycles	Passed

Conclusions Drawn From Testing E.

Testing of the modified Silhouette™ Spinal Fixation System demonstrates that the device is substantially equivalent to the predicate Silhouette™ Spinal Fixation System and that the design modifications do not affect device safety and effectiveness

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1999

Ms. Janell A. Colley Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027

Re: K993067

Trade Name: Silhouette™ Spinal Fixation System Regulatory Class: II Product Codes: KWP, MNH and MNI Dated: October 21, 1999 Received: October 22, 1999

Dear Ms. Colley:

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 Ouality System Regulation (OS) 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. Janell A. Colley

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 toll-free number (800) 638-2041 or at (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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INDICATIONS FOR USE STATEMENT

510(K) Number: K993067

Silhouette™ Spinal Fixation System Device Name:

Indications for Use:

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization 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 Silhouette™ Spinal Fixation System is indicated for use in patients:

having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint a)
who are receiving fusions with autogenous graft only b)
who are having the device fixed or attached to the lumbar or sacral spinc, and c)
d) who are having the device removed after the development of a solid fusion mass

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AR colep B

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993067

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter-Use

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.