The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using 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 Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined 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 sacral/iliac attachment only, screws of the Spin-Tech 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 Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136.

The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

AI/ML Overview

The provided document is a 510(k) summary for the Spine-Tech Silhouette™ Spinal Fixation System. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not contain information regarding specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details about a test set, ground truth, or expert involvement typically associated with AI/software device evaluations.

Instead, this document focuses on a medical device (spinal implant system) rather than a software or AI-based diagnostic/predictive device. The "testing" mentioned refers to biomechanical testing of the physical implants.

Therefore, many of the requested categories are not applicable to the content provided.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (If Applicable, for Software/AI)	Reported Device Performance (from K980288)
Not applicable (Device is a physical spinal implant system)	"Components of the Spine-Tech Silhouette Spinal Fixation System demonstrated equivalent mechanical performance as compared to several commercially available spinal fixation systems."

Explanation: The document does not specify quantitative acceptance criteria in terms of performance metrics commonly associated with software/AI (e.g., sensitivity, specificity, AUC). The performance reported is that the physical device components showed "equivalent mechanical performance" to predicate devices.

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

Sample Size for Test Set: Not applicable. The "testing" refers to biomechanical tests on device components, not a clinical test set from human data for an AI/software.
Data Provenance: Not applicable. The biomechanical testing would have been conducted in a lab setting, not using human data from a specific country or in a retrospective/prospective manner.

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

Number of Experts: Not applicable. Ground truth, in the context of AI/software, refers to clinically verified labels or outcomes. For biomechanical testing, the "ground truth" would be established by engineering standards and measurements, not clinical experts.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there is no clinical test set or ground truth adjudication process described.

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

MRMC Study: No, this type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images, often with AI assistance. This document describes a physical spinal implant system.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used

Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established engineering and materials science standards for spinal implants (e.g., ASTM F-136 for titanium alloy, specifications for load-bearing, fatigue, etc.). This is a physical or engineering "ground truth," not a clinical ground truth.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document is not about an AI/ML model, so there is no training set in that sense. The design and manufacturing processes are informed by engineering principles and possibly prior iterations, but not a "training set" of data.

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

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model. The design and manufacturing of the physical device components are based on established engineering and medical device standards.

Summary of Document's Focus:

The K980288 document is a premarket notification for a physical medical device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, primarily through comparison of materials, design, function, and biomechanical testing. It does not involve software or artificial intelligence, and therefore, the requested information pertaining to AI/software validation studies is not present.

Summary

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K980288

1017 2 9 1998

510(k) Summary of Safety and Effectiveness

Company Name:	Spine Tech, Inc.7375 Bush Lake RoadMinneapolis, MN 55439-2027(612) 832-5600
510(k) Contact:	David A. CannistraciDirector of Regulatory Affairs(612) 832-5600
Trade Name:	Spine-Tech Silhouette™ Spinal Fixation System
Common Name:	Hook, rod and screw spinal instrumentation
Classification:	888.3050 Spinal interlaminal fixation orthosis
Device Product Code:	87 KWP and MNH
Substantially EquivalentDevices:	Depuy Motech MOSS Miami Spinal SystemSofamor Danek Multi Axial ScrewSofamor Danek TSRH™ Spinal SystemWright Medical Technology Wrightlock™Spinal SystemWright Medical Technology Versalok™ LowBack Fixation System

Device Description

The Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to The Spine-Tech Silhouette™ Spillal Fixation System is access of spinal fusion. This system is
correct spinal deformity and facilitates the biological process of the snine. correct spinal deformity and tacilitares turns and sacras of the spine. Implants of this intended for posterior use in the thoracic, in the sacer orended to be removed atter
system consist of hooks and/or screws c; a selection is serving diameters and system consist of hooks and/or screws comics polyaxia screws of varying diameters and solid fusion has occurred. This system moded porphs, rods in varying lengths, hooks in
lengths, fixed screws of varying diameters and lengt and in varying lengths, and lengths, fixed screws of varying maneters both fixed and in table. All implants on the varying designs, and transverse connectus oon fixed and copense manufactured from titanium
are top loading and top tightening. The implants in this system are manufactured fr alloy (Ti-6A1-4V), conforming to ASTM F-136.

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The implants of this system are for single use only. An implant should never be reused after this The implants of this system are for single use only. An implant into are and with body fluids or tissues.
being removed from the body or sterlized after coming into contact

Intended Use

The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation
Spine-Tech Silhouse in antimestimes of having severe spondylolisthesis (Grade 3 and 4 The Spine-Tech Silhouette Spinal Fixation System, when used as ipbexist of the Spine 3 and 4) at the
system, is indicated for use in patients: a) having severe spondy of who system, is indicated for use in patients: a) having sever spoliaf care having the
LS-S1 joint; b) who are receiving fusion using autogenous graft only: c) who are having the L S-S I joint; b) who are receiving fusion using audogenous glaving the device
device fixed or attached to the lumbar or sacral spine; and d) who are having the device E S Jean + )
removed after the development of a solid fusion mass. When is a fisse first fission in fusion
removed after the development of a solid fision mass. When is and removed after the development of a solid fusion mass. Wilch assuser and and the may span from L3
mass may not go above the L5-S1 joint, the levels of pedicle screw fixation to the sacrum.

When used as a hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation
al consistence in the species the treatment of degenerative disc disease ( as defined b When used as a hook and screat system, the Spiners of assesses ( as defined by chromo
System is intended for use in the treatment of disc confimed by a history and System is intended for use in the treatment of the disc confimed by a history and back pain of discogenic origin with degeneration of the use committee of lordotic deformity of
radiographic studies), idiopations spondylolistesss, kyphotic or lordotion, radiographic studies), idiopathic scoliosis, spinal stenosis, systems from the or dislocation,
the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture the spine, loss of stability due to lumors, spinal fields to this indication, screws of the
pseudoarthrous failed spinal fusion. When used for sacralities attachment only. pseudoarthrosis, and previous failed spiral installed for sacealitiac attachment only.
Spin-Tech Silhouette Spinal Fixation System are intended for socrabiliae attachment onl point in Silhouette Spinel Fixtion System are intended for posterior horacie ander lumbar
Hook and transvers connectors of the system are intended for posterior of this syste . Hook and transverse connectors of the system are miended for posterior and the more of this system are T l
use only. As a whole, the levels of use for hook and sacral scre to the sacrum.

Testing

Biomechanical testing was performed and supplied in support of the Spine-Tech
of the Spines and supportuned and supportune schat notification. Components of the Spine-Tech Biomechanical testing was performed and supplied in supportents of the SpineSilhouette Spinal Fixation System prematicated equivalent mechanical Silhouette Spinal Fixation System demonstrated equivalent mechanical
Tech Silhouette Spinal Fixation System demonstrated equivalent mechanical Tech Silhouette Spinal Fixation System denonstrated equivaliation systems.
performance as compared to several commercially available spinal fixation systems.

Basis for Substantial Equivalence

The Spine-Tech Silhouette Spinal Fixation System is substantially equiry1ent in
ternal System of Canada of the Depart Motech MOSS Miami Spinal System The Spine-Tech Silhouette Spinal Fixanon System I. MOSS Miami Spinal System,
Material, design, and function to the Depuy Motech MOSS Miami Systems, and the Material, design, and function to the Depty Motor ... Pirstion Systems, and the
Sofamor Danek Multi Axial Screw and TSRH™ Spinal Fixation Sofamor Danek Multi Axial Sciew and TOREA - Specialism Low Back Fixation
Wright Medical Technology Wrightlock™ and Versalok™ Low Back Fixation Systems

Due to the similarity of materials and design to both pre-enactment and post-Duc to the similarity of materials and cestar the Spine-Tech Silhouette Spinal
cuactment devices, Spine-Tech believes that the Spine-Tech Silhouette Spinal cnactment devices, Spine-Tech believes and new specifically of effectiveness issues.

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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 stylized eagle or bird-like figure with three curved lines representing the body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 29 1998

Mr. David A. Cannistraci Director of Regulatory Affairs Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027

Re: K980288 Silhouette™ Spinal Fixation System Regulatory Class: II Product Codes: KWP and MNH Dated: July 13, 1998 Received: July 14, 1998

Dear Mr. Cannistraci:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of 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. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(t)(1) of the Act.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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Page 2 - Mr. David A. Cannistraci

All labcling for this device, including the package label, must state that there are 1 . An labeling for this delece, insert must prominently state that the device fabeling inimations. The package intended only for patients: (a) having severe system using pediele serews is intended only 101 plan - first sacral (LS-S1) vertebral spondylonsmesis (Crades 5 and 1) of integenous bone graft only; (c) who are joint, (0) who are receiving assisted to the lumbar and sacral spinc; and (d) who are having the device removed after the development of a solid fusion mass.
You may not label or in anyway promote this device system for pedicular, screw 2. 1 ou may not laber of in ally hay prohovic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS:

When used as a pedicle screw system, this device system is intended only for . grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (I.5-S1) vertebral joint.
The screws of this device system are not intended for insertion into the . pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
Benefit of spinal fusions utilizing any pedicle screw fixation system has not . been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may � require additional surgery, include:
- device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. . .

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

Any pedicular screw fixation/attachment for intended uses other than severe 3. spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other

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than severe spondylolisthesis, as described above, must receive approval from their than severe spondylonsmools, as deels (URBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

Any previous warning statements identified as part of previous 510(k) clearances or 4. Ally provious walling statements would which stated that a component/system was required by OC/Laooming and Fromotion with pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
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 (Tremarket Approval), it may of subject to satis the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the r ars 600 to 699. Tractice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: Gencral 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 suein assumptions. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does r cueral regions. Prease now right have under sections 531 through 542 of the Act for not any obligation you might thatiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of your device system with any other device components but those i Drises that this 510(k) would require submission of a new 510(k) providing documentation idontinou in this of of(it) 'nbeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers; may also be required: This letter will allow you to begin marketing your device as described in your 510(K) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 4 - Mr. David A. Cannistraci

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,

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) #K980288

Device Name: · Spine Tech Silhouette™ Spinal Fixation System

Indications for Use:

The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation
Spand The Spine-Tech Silhouette Spinal Fixation System, when shoodylolisthesis (Grade 3 and system, is indicated for use in patients. "a) fish asocenous graft only; c) who are having 4) at the LS-S1 joint; b) who are receiving lumbar or sacral spine; and d) who are having
having the device fixed or attached to the lumba asala firing used for this having the device tixed or allacined of a solid fision mass. When used for this the device removed after the development of a sono resion mass
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 Spine-Tech Silhouette Spinal Fixation
All States of Sacract Career of Areasonal of Advense (as defined by When used as a nook and sacral screw system, are apartive disc dise disc disc disc confirmed by System is intended for use in the deather of the degeneration of the disc confimed by a history and radiographic studies), idiopatiic scodiosis, spondylolistics, kyphotic or
history and radiographic studies), idiopatiic scolosis, spondy stenosis, vertebral lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous fuiled spinal fusion. When used for fracture or dislocation, pseudoalunosis, and Silhovete Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse comectors of the system are
for sacral/iliac attachment only. Hook and transverse comectors of use for for sacrabiliac attachment offic. Including issues as a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

uation (ODE)

(Division Sign-Om)
Division of General Restorative De 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 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.