Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX® Spinal System, PILOT® Spinal System, PILOT® Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Life Spine Interspinous Fixation System is not intended for standalone use.

Device Description

The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient.

The implants are designed to sit between two spinous processes in order to maintain distraction between the vertebrae. There are plates on both sides of the spinous processes, and the plates are translationally adjustable to one another to accommodate different widths. The plates include spikes which anchor the implant to the spinous processes to prevent migration.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Life Spine Interspinous Fixation System), not a study evaluating a device's performance against acceptance criteria in the typical sense of a clinical trial or AI/software validation study.

The acceptance criteria for this type of submission are not performance metrics like sensitivity or specificity, but rather demonstration of substantial equivalence to a legally marketed predicate device. The "study" proving this is a comparison of the new device to predicate devices across various attributes.

Here's the breakdown based on the provided text, reinterpreting the concepts for this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence): The new device (Life Spine Interspinous Fixation System) must be substantially equivalent in:

Design
Materials
Function
Indications for Use

Reported Device Performance (against Substantial Equivalence criteria):

Feature	Acceptance Criteria (Substantial Equivalence)	Life Spine Interspinous Fixation System Performance
Design	Equivalent to predicate devices	"equivalent, and in many cases superior" to predicate devices based on mechanical testing (Static Axial Compression, Static Torsion, Static Axial Pullout, Dynamic Axial Compression, Static Axial Grip Strength). Design description of two plates with translationally adjustable spikes to anchor to spinous processes, similar to predicate devices.
Materials	Equivalent to predicate devices	Titanium alloy 6AL-4V-ELI per ASTM F136 (same as predicates).
Function	Equivalent to predicate devices	Intended to stabilize and maintain alignment (similar to predicates); serves as a posterior, non-pedicle supplemental fixation device for single level supplemental fusion in specific conditions (similar to predicates).
Indications for Use	Equivalent to predicate devices	Indications for use are explicitly listed and largely align with those of the predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This is a mechanical testing study on the device itself, not a clinical study with patients or data. The "test set" refers to the physical devices undergoing mechanical tests. The number of devices tested is not specified but would be typical for biomechanical evaluations.
Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the physical implants.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts/Qualifications: Not applicable. This is not a study requiring expert readers or interpretation of medical images/patient data to establish ground truth. The "ground truth" for mechanical testing is established by engineering standards (ASTM Standard F1717-04).

4. Adjudication method for the test set

Adjudication Method: Not applicable. No human adjudication of data is mentioned or required for in vitro mechanical testing against a standard.

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: Not applicable. This is a 510(k) submission for a physical implant, not an AI or software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The "ground truth" for the mechanical testing is established by a modified version of ASTM Standard F1717-04. This standard provides the benchmark for acceptable biomechanical performance of spinal fixation devices.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not a machine learning study.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. This is not a machine learning study.

Summary

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30402 Page 114

510(k) Summary Life Spine Interspinous Fixation System

NOV - 5 2010

Submitted By:	Life Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.2401 W. Hassell Road, Suite 1535Hoffman Estates, IL 60169Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	February 8, 2010
Trade Name:	Life Spine Interspinous Fixation System
Common Name:	Interspinous Process Fixation System
Classification:	MNH, 888.3070, Class II, Spondylolisthesis SpinalFixation Device SystemMNI, 888.3070, Class II, Pedicle Screw Spinal SystemKWP, 888.3050, Class II, Spinal Interlaminal Fixation Orthosis

Device Description:

The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental The Ene Spine Intenspirious I main the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to manufavored trom thanlogy and anatomical conditions of the patient.

Intended Use of the Device:

Internal fixation implants are load-sharing devices intended to stabilize and maintain internal inxation infinants are road that ing alants are not intended to replace normal body anginnent until normal neaming over in the presence of incomplete bone healing.

The ARX® Spinal System, PILOT® Spinal System, PILOT® Posterior Lumbar Plating The ARA Spinal System, I ILOT "Spinal System, when properly used, are intended for posterior System, and CONQUEST - Upinal Sycal posterior spine in skeletally mature patients. pedicte sciew fixation of the non-bor vilization of spinal segments as an adjunct to fusion.

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When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scollosis, kyphosis, and/or lordosis), (4) spinal turnor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Test Data:

The Life Spine Interspinous Fixation System was tested according to a modified version of ASTM Standard F1717-04. The tests performed were Static Axial Compression, Static Torsion, Static Axial Pullout, Dynamic Axial Compression, and Static Axial Grip Strength.

Testing Conclusions:

Analysis and interpretation of the test results show that the Life Spine device is equivalent, and in many cases superior, to the predicate devices.

Substantial Equivalence:

The Life Spine Interspinous Fixation System is substantially equivalent in design, materials, function and indications for use to the predicate devices presented.

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VSIStAmaly1
omparison1)1



able

E

Feature	Life Spine Interspinous Fixation System	Lanx Spinal Fixation System (K071877& K90252)	CD Horizon Spinous Process Plate (K032037)
Indications for Use	Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.The ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.	The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.The Lanx SFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for 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 (pseudoarthrosis).	The CD HORIZON SPINOUS PROCESS Plate is posterior, non- pedicle supplemental fixation device, intended for use in the non- cervical spine (T1-S1). It is intended or plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Spodylolisthesis, Trauma (i.e., fracture or dislocation), Tumor. The CD HORIZON SPINOUS PROCESS Plate is not intended for stand-alone use.
	When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.	The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use in the non- cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or spinal tumor. The Lanx SPFP is intended for use with bone graft material and is not intended for stand-alone use
	The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving

he Life Spine Interspinous Fixation System

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111
1t1

Supplied Non-Sterile	Supplied Non-Sterile	Supplied Non-Sterile	Sterile / Non-Sterile
Titanium alloy 6AL-4V-ELI per ASTM F136	Titanium alloy per ASTM F136	Titanium alloy per ASTM F136	Material
The implants are designed to sit between twospinous processes in order to maintain distractionbetween the vertebrae. There are plates on bothsides of the spinous processes, and the plates aretranslationally adjustable to one another toaccommodate different widths. The plates includespikes which anchor the implant to the spinousprocesses to prevent migration.	The implants are designed to sit between twospinous processes in order to maintaindistraction between the vertebrae. There areplates on both sides of the spinous processes,and the plates are translationally adjustable toone another to accommodate different widths.The plates include spikes which anchor theimplant to the spinous processes to preventmigration.	The CD HORIZON SPINOUSPROCESS Plate is posterior, non-pedicle supplemental fixationdevice, intended for use in the non-cervical spine (T1-S1). It isintended or platefixation/attachment to spinousprocess for the purpose of achievingsupplemental fusion in thefollowing conditions:Degenerative disc disease - definedas back pain of discogenic originwith degeneration of the discconfirmed by history andradiographic studies.Spodylolisthesis, Trauma (i.e.,fracture or dislocation), Tumor.The CD HORIZON SPINOUSPROCESS Plate is not intended forstand-alone use.	Design / Description
Overall Width: 14mmLengths: 8mm-18mm; 2mm increments	Overall Widths: 8mm, 14mmLengths: 8mm-18mm; 2mm increments	Overall length: 35mm, 45mmHeight: 12mmThickness (per plate): 3mm	Sizes
The Life Spine Interspinous Fixation System is aposterior, non-pedicle supplemental fixation device,intended for use in the non-cervical spine (T1-S1).Implants are manufactured from or titanium alloy(6AL-4V-ELI per ASTM F136) and are available ina range of sizes to suit the individual pathology andanatomical conditions of the patient.	The Lanx Spinous Process Fusion Plates aremanufactured from titanium alloy per ASTMF136 and are available in a range of sizes tosuit the individual pathology and anatomicalconditions of the patient.	supplemental fusion in the following conditions: (1)degenerative disc disease (is defined as back pain ofdiscogenic origin with degeneration of the disc asconfirmed by patient history and radiographicstudies), (2) trauma (i.e., fracture or dislocation), (3)spinal tumor, (4) spondylolisthesis. The Life SpineInterspinous Fixation System is not intended forstand-alone use.

K10 0407
Pageu

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Life Spine, Inc. % Mr. Randy Lewis RA/QA Manager 2401 West Hassell Road. Suite 1535 Hoffman Estates, Illinois 60169

NOV - 5 2010

Re: K100407

Trade/Device Name: Life Spine Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: October 21, 2010 Received: October 22, 2010

Dear Mr. Lewis:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Randy Lewis

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark A. Milliman

Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number (if known):

K100407

NOV - 5 2010

Device Name:

Life Spine Interspinous Fixation System

Indications for Use: Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K100407 510(k) Number_

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.