The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions.
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroillitis and sacroiliac joint disruptions.

Device Description

The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. All implants will be provided non-sterile, and are intended for single use only and should not be reused under any circumstances.

AI/ML Overview

The provided text describes a medical device, the Silex™ Sacroiliac Joint Fusion System (K123702), and its regulatory clearance process. The study presented is a biomechanical performance study for this orthopedic implant, not a study evaluating an AI-powered diagnostic or assistive device.

Therefore, many of the requested criteria (e.g., acceptance criteria for device performance (like sensitivity/specificity), sample size for test set, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as they relate to the evaluation of AI/diagnostic algorithms.

This submission focuses on demonstrating the substantial equivalence of a physical medical implant to existing predicate devices based on its mechanical performance and material properties.

Here's a breakdown of the applicable information:

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

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Material Composition: Conformance to Titanium alloy (ASTM F136)	Manufactured from Titanium alloy in accordance with ASTM F136
Plasma Coating (Optional): Conformance to CP Ti (ASTM F1580)	Optionally plasma coated with medical-grade CP Ti per ASTM F1580
Torsional Properties of Metallic Bone Screws (ASTM F543 - Annex 1)	Tested to ASTM F543 - Annex 1
Driving Torque of Medical Bone Screws (ASTM F543 - Annex 2)	Tested to ASTM F543 - Annex 2
Axial Pullout Strength of Medical Bone Screws (ASTM F543 - Annex 3)	Tested to ASTM F543 - Annex 3
Static and Fatigue Bending Strength of Metallic Spinal Screws (ASTM F2193 - Annex 4)	Tested to ASTM F2193 - Annex 4
Substantial Equivalence: Performance comparable to predicate devices in terms of mechanical behavior.	Biomechanical testing results indicate substantial equivalence to predicate device performance and capability for safe and effective 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 explicitly stated in the document in terms of human subjects or distinct test articles beyond the mention of "implant components." Biomechanical testing typically involves a set number of physical samples (e.g., screws) tested under various conditions to destruction or a specified number of cycles. The document does not specify if these were new test samples or existing products.
Data Provenance: Not applicable in the context of clinical data provenance. The testing was biomechanical (laboratory-based).

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 this context refers to the defined mechanical properties and limitations specified by the ASTM standards, which are developed by expert committees in materials and medical devices. It is not about expert interpretation of clinical data.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data or images. This study is a biomechanical engineering test, not a clinical study with subjective assessments.

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

Not Applicable. This is a biomechanical study of a physical implant, not an AI-powered diagnostic or assistive device.

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

Not Applicable. This is a biomechanical study of a physical implant, not an AI algorithm.

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

Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by the specified requirements and methodologies in the ASTM standards (ASTM F543, ASTM F2193) and the demonstrated performance of the predicate devices. The Silex system aims to meet or exceed these established benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

Not Applicable. This is a biomechanical study of a physical implant, not a machine learning model requiring a training set.

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

Not Applicable. This is a biomechanical study of a physical implant, not a machine learning model.

Summary

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K123702

510(k) Summary

MAR 1 1 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name:

X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342

Telephone (937) 847-8400 FAX (937) 847-8410

Official Contact:

David Kirschman, M.D. Chief Medical Officer

Date Prepared:

10/30/2012

DEVICE NAME

Trade/Proprietary Name:	Silex™ Sacroiliac Joint Fusion System
Common Name:	Sacroiliac Joint Fixation / Sacroiliac Joint Fusion
Device Class:	Class II
Regulation Number:	§888.3040
Product Code:	OUR
Classification Name:	Smooth or threaded metallic bone fixation fastener

ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

INTENDED USE

The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliac joint disruptions.

DEVICE DESCRIPTION

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K123702

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 Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate devices based on a comparison including the following characteristics:

FDA Product Code .
Intended Uses ●
. Surgical Approach
. Anatomical Region
. Implant Materials
. Product Dimensions
. Mechanical Performance

PREDICATE DEVICES

. Synthes (USA) - 6.5mm Cannulated Screw (K021932 )
Zyga Technology, Inc. SImmetry Sacroilliac Joint Fusion System (K102907) ●
SI-Bone, Inc. Sł Joint Fusion System (K092375) .

PERFORMANČE DATA

The implant components were tested using the following standards:

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

Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone Screws .
Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws .
Annex 3 (A3) Test Method for Determining the Axial Pullout Strength of Medical Bone Screws ●

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

Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal . Screws
In conclusion, biomechanical testing results indicate that the Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Re:

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 11, 2013

X-Spine Systems, Inc. David Kirschman, M.D. 452 Alexandersville Rd. Miamisburg, OH 45342

K123702 Trade/Device Name: Silex sacroiliac joint fusion system Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: Jan. 30, 2013 Received: Feb. 8, 2013

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, 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 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 - Dr. David Kirschman

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin Neith

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

Enclosure

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Indications for Use

510(k) Number (if known): _K123702

Device Name: Silex 161 Sacroiliac Joint Fusion System

Indications for Use:

The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroillitis and sacroiliac joint disruptions.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabethji 👍張rank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.