The Spinal Innovations REVOLUTION ™ 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.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degencration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.

Device Description

The Spinal Innovations REVOLUTION ™ 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 fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Spinal Innovations REVOLUTION™ Spinal Fixation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biomechanical Performance	Interconnection testing of individual system components	Per ASTM F 1798-97	"The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards."
Biomechanical Performance	Static flexion/extension testing	Not explicitly stated, implied by comparison to predicate devices	"The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards."
Biomechanical Performance	Fatigue flexion/extension testing	Not explicitly stated, implied by comparison to predicate devices	"The testing results of the various system components show that the data compares directly to predicate testing and meets or exceeds only predicate device data standards."
Overall Equivalence	Material, Design, and Function	Substantially equivalent to predicate devices	"The Spinal Innovations REVOLUTION™ Spinal Fixation System is substantially equivalent in material, design and function to the predicate devices."

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

Sample Size for Test Set: Not explicitly stated. The document refers to "various system components" being tested, implying a range of components were subjected to the biomechanical tests.
Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission for a spinal fixation system, the testing would be conducted in a laboratory setting, likely in the country of origin of the manufacturer (Tennessee, USA). The study is prospective in the sense that the device was manufactured and then tested to demonstrate its performance.

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

This is not applicable to this type of study. The ground truth for this device's acceptance is established through objective, quantitative biomechanical testing against established ASTM standards and comparison to predicate devices, not through expert consensus on qualitative data.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Biomechanical testing results are objective measurements and do not require adjudication in the same way clinical or imaging studies might.

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

No, an MRMC comparative effectiveness study was not done. This document describes a biomechanical performance study of a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device's acceptance is based on objective biomechanical measurements and established engineering standards (ASTM F 1798-97). The device's performance is compared directly against the performance of legally marketed predicate devices, implying that their established performance serves as the "ground truth" for what is considered safe and effective in this context.

8. The Sample Size for the Training Set

Not applicable. This is a biomechanical study, not a machine learning study. There is no "training set" in the context of device performance testing through physical measurements.

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

Not applicable. See point 8.

Summary

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DEC 1 9 2003

K0 32219 p1/2

510 (K) Summary of Safety and Effectiveness

Company Name:	Spinal Innovations, Inc.
	7850 Stage Hills Blvd.
	Suite 105
	Bartlett, TN 38133
	(901) 373-8855
	(901) 373-8303 fax
510(k) Contact:	Joe Clift
	Vive President of Regulatory
	Affairs
	(901) 373-8855
Trade Name:	Spinal Innovations REVOLUTION™
	Spinal Fixation System
Common Name:	Hook, Rod and Screw Spinal Fixation System
Classification:	888.3050 Appliance, Fixation, Spinal
	Interlaminal - class II
	888.3070 Orthosis, Spondylolisthesis Spinal
	Fixation - class II
	888.3070 Orthosis, Spinal Pedicle Fixation - class II
Device Product Code:	87 KWP, MNH and MNI
Predicate Devices:	Silhouette™ Spinal System by Centerpulse
	Spine-Tech.
	CD Horizon Multi Axial Screw System and
	TSRH™ Spinal Implant System by Sofamor
	Danek, Inc
	MOSS™ Miami System by DePuy Motech,
	Inc.
	Ascend™ Spinal System with the Shadow™
	Spinal System by Spinal Innovations, Inc.

Device Description

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K03219 p²/₂

Intended Use

The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw The Spinal Innovations ICE VOLO HOT - Spinal Landing severe spondylolisthesis (Grade 3) who are having the fixation system, is indicated for use in pations: a) na nig consums graft only, a) who are having the daving the daying tempyed at the LS-5 I Joint, by Milo are receiving rusing and d) who are having the device removed device fixed of allached to the lambal of bactar spans, and cation, the fisses I 2 to the secom atter the development of a sold fusion mass. "Then assuration may span from L3 to the sacrum.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system The Spinal Innovations RE VOLOTION - Upinal Profital segments in sketetally mature patients
intended to provide immobilization and stabilization of spinal instabilities or intended to provide initifoomization and the following acute and chromic instabilities of as an adjunct to fusion in the treatment of the idegenerative spondylolisthesis with objectives, and deformities of the thoracic, fracture, and sucral spire. Segmentliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high When used as a nook and sacral serew system (GEVOLUTION TM Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of intended for use in the treatment of degeneration of the discory and radiographic studies of seatility, dissogenic origin with the degoneration or the one ordotic deformity of the spine, loss of stability idiopathic scollosis, spolloyfolishesis, typical or dislocation, pseudoarthrosis, and previous failed due to tunfors, spinal stonosis, verter this indication, screws of the Spinal Innovations spinal surgety/lusion. When used for this intended for sacral/iliac atachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook the system are w fixation of this system are T1 to the sacrum.

Testing

Biomechanical testing demonstrated that the components of the Spinal Innovations REVOLUTION Biomechanical testing demonstrated that the complex.
TM Spinal Fixation System exhibit equivalent mechanical performance compared to predicate devices. Testing included the following:

1. Interconnection testing of individual system components per ASTM F 1798-97. The testing Intercomection resultig of maividual system components per raxion/extension static and fatigue testing.
  Testing results of the various system components show that the data compares directly to precity the Testing results of the various system oomponents bab it sees. Therefore, the results support that the device testing and meets of exceeds only procruite as a convalent to the predicate devices.

Basis for Substantial Equivalence

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is substantially equivalent in material, design and function to the predicate devices.

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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 features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Mr. Joseph S. Clift Vice President, Regulatory Affairs Spinal Innovations, Inc. 7850 Stage Hill Boulevard, Suite 105 Bartlett, Tennessee 38133

Rc: K032219

Trade Name: Spinal Innovations REVOLUTION" Spinal Fixation System Regulatory Number: 21 CFR 888.3070, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: October 28, 2003 Received: November 28, 2003

Dear Mr. Clift:

We have reviewed your Scction 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, 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 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 - Mr. Joseph S. Clift

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), 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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO32219 510(K) Number

Device Name: Spinal Innovations REVOLUTION ™ Spinal Fixation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use OR

for Mark-N Millman (Opti

Optional Format 1-2-96)

ision Sign-Off)
Division of General, Rest
and Neurological Devices

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.