The X-spine Systems, Inc. Fixcet Spinal Facet Screw system is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system.is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc . as confirmed by patient history and radiographic studies),
. Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
. Trauma (i.e., fractures and/or dislocations),
. Spondylolisthesis,
. Spondylolysis,
. Pseudoarthrosis and/or failed previous fusions.

Device Description

The X-spine Fixcet Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. This system consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping 4.5mm diameter facet screws are available in two configurations: (1) single-threaded screws offered in lengths of 25-45mm (in 5 mm increments); and (2) dual-threaded screws offered in lengths of 30-45mm (in 5 mm increments). The screws are composed of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136.

The implant components are provided clean and non-sterilized by a healthcare professional using Steam Autoclave in accordance to the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Fixcet™ Spinal Facet Screw System. This is a medical device and the submission focuses on its substantial equivalence to previously marketed devices based on mechanical performance tests, rather than a study involving human subjects or AI performance.

Therefore, many of the requested categories regarding acceptance criteria for AI/human reader performance, sample sizes for test/training sets, expert involvement, and ground truth types are not applicable in this context.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the standards the device was tested against. The reported performance is that the device met these standards and was found substantially equivalent to predicate devices.

Acceptance Criteria (Standard & Test)	Reported Device Performance
ASTM F2193 – Static Compression Bending	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F2193 – Fatigue Compression Bending	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F543 – Torsional Yield Strength	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F543 – Insertion Torque	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F543 – Removal Torque	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F543 – Pullout Force	Indicates substantial equivalence and ability to perform in accordance with intended use.
ASTM F543 – Self-Tapping Performance	Indicates substantial equivalence and ability to perform in accordance with intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The performance data section refers to "implant components" being tested using standards, which implies in-vitro mechanical testing rather than human subject data.
Data Provenance: Not specified. Given it's mechanical testing of implant components, location of testing might be relevant, but patient data provenance is not. This is a premarket notification for a medical device focusing on mechanical properties, not clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for this mechanical device testing. The "ground truth" for mechanical testing is adherence to the specified ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human reader interpretation.

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. This is not a study comparing human reader performance with or without AI assistance.

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

No. This document does not pertain to an algorithm or AI.

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

The "ground truth" for this device's performance is adherence to established engineering and material science standards as defined by ASTM F2193 and ASTM F543 for orthopedic implants.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning study, so there is no concept of a "training set."

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

Not applicable. There is no training set.

Summary

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100154

MAY 2 1 2010

510(k) SUMMARY

ADMINISTRATIVE INFORMATION

Manufacturer Name:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
	Telephone (937) 847-8400FAX (937) 847-8410
Official Contact:	David Kirschman, M.D.Chief Medical Officer
Date Prepared:	January 15, 2010 (revised April 21, 2010)
DEVICE NAME
Trade/Proprietary Name:	Fixcet™ Spinal Facet Screw System
Classification Name:	System, Facet Screw Spinal Device
Common Name:	Facet Screw

ESTABLISHMENT REGISTRATION NUMBER

X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

DEVICE CLASSIFICATION

FDA has classified facet screw spinal devices as Unclassified. The product code for System, Facet Screw Spinal Device is MRW. These device classifications are reviewed by the Orthopedic Devices Branch.

INTENDED USE

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Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc . as confirmed by patient history and radiographic studies),
. Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
. Trauma (i.e., fractures and/or dislocations),
. Spondylolisthesis,
. Spondylolysis,
. Pseudoarthrosis and/or failed previous fusions.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Fixcet Spinal Facet Screw system is substantially equivalent to the Depuy Spine Discovery System (K012773) and the SpineFrontier Chameleon System (K071420) based on a comparison of the following:

. FDA Product Code
. Intended Uses
Surgical Approach ●
. Levels of Fixation
Implant Materials .
� Product Dimensions
. Mechanical Performance

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PERFORMANCE DATA

The implant components were tested using the following standards:

ASTM F2193 – Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Static Compression Bending .
Fatigue Compression Bending .

ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws

. Torsional Yield Strength
. Insertion Torque
Removal Torque .
. Pullout Force
� Self-Tapping Performance

In conclusion, biomechanical testing results indicate that the Fixcet Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of performing in accordance with its intended use.

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Image /page/3/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 and a flowing design below, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

MAY 2 1 2010

X-Spine Systems, Inc. % David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K100154

Trade/Device Name: Fixcet™ Spinal Facet Screw System Regulation Number: Unclassified Product Code: MRW Dated: April 21, 2010 Received: May 19, 2010

Dear Dr. Kirschman:

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. 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 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.

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Page 2 - David Kirschman, M.D.

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 vours.

Soubare buchanD

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

510(k) Number (if known): K100154

Device Name: Fixcet™ Spinal Facet Screw System

Indications for Use:

The X-spine Systems, Inc. Fixcet Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral . radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
. Trauma (i.e., fractures and/or dislocations),
. Spondylolisthesis,
. Spondylolysis,
. Pseudoarthrosis and/or failed previous fusions.

Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)

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

(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 Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K100154

Page 1 of 1

Regulation Number and Section

N/A