The SICONUS™ SI Joint Fixation System is intended to provide fixation of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.

Device Description

The Camber Spine Technologies Siconus™ SI Joint Fixation System is a partially threaded, fully cannulated, bone fixation device that has a threaded distal end with a buttress-style profile in order to secure the device in cancellous bone. The proximal head of the device has a conical shape that provides axial compression of the bones across the sacroiliac joint in order to promote fusion. The head of the device also contains a tapered that allows the device to advance into hard cortical bone by displacing material, while also maintaining compression and preventing movement of the device. The proximal head and distal thread is connected by a smooth shaft. In the large version of the device, this shaft contains a slot along the axis to permit packing with bone graft to facilitate fusion.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "Siconus™ SI Joint Fixation System." This document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's performance.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI algorithms is not present in the provided text.

The text describes mechanical performance testing of the physical medical device (implants and screws) against predicate devices, but this is not an evaluation of an AI algorithm.

Here's an attempt to extract what is available, and clearly state what is missing based on your specific request for AI device evaluation:

The document describes the Siconus™ SI Joint Fixation System, a partially threaded, fully cannulated bone fixation device for sacroiliac joint fusion.

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

Test Type	Acceptance Criteria	Reported Device Performance
Static Torsion	Not explicitly stated; implied to meet or exceed predicate device performance.	Performs equally or better as compared to the predicate devices.
Static Bending	Not explicitly stated; implied to meet or exceed predicate device performance.	Performs equally or better as compared to the predicate devices.
Dynamic Bending	Not explicitly stated; implied to meet or exceed predicate device performance.	Performs equally or better as compared to the predicate devices.
Screw Thread Pullout	Not explicitly stated; implied to meet or exceed predicate device performance.	Performs equally or better as compared to the predicate devices.
General	Equivalent to or exceeding performance of predicate devices per ASTM F2193-02 & F543-07	Subject device is equivalent or exceeds the acceptance criteria defined by equivalent tests performed on the predicate devices.

Important Note: The acceptance criteria are not explicitly quantifiable values in this document. Instead, they are defined relative to the performance of predicate devices and compliance with ASTM standards. The "device performance" refers to the mechanical performance of the physical implant, not an AI algorithm.

The following information is NOT available in the provided text as it pertains to an AI device evaluation, which is not the subject of this 510(k) document:

2. Sample sizes used for the test set and the data provenance: Not applicable to a physical implant's mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on physical measurements and engineering principles, not expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI sense. Ground truth for mechanical testing would be the results of the physical tests themselves.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures in profile facing right. The figures are stacked vertically, suggesting a sense of community and support.

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

January 18, 2017

Camber Spine Technologies % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs MCRA, LLC 1331 H St NW, 12th Fl Washington, District of Columbia 20005

Re: K162121

Trade/Device Name: Siconus™ SI Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 11, 2017 Received: January 13, 2017

Dear Mr. Eggleton:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Lori A. Wiggins -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162121

Device Name Camber Spine Technologies SICONUSTM SI Joint Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Trade Name	Siconus™ SI Joint Fixation System
Common Name	SI Joint Screw System / SI Joint Fixation System
Manufacturer	Camber Spine Technologies
	418 E. Lancaster Ave.
	Wayne, PA 19087
Contact	Justin Eggleton
	Senior Director, Spine Regulatory Affairs
	Musculoskeletal Clinical Regulatory Advisers, LLC
	1331 H Street NW, 12th Floor
	Washington, DC 20005
	Phone: (202) 552-5800
	jeggleton@mcra.com
Prepared By	Mr. Damian Heinz, PE
	Senior Principal Engineer
	Institute of Musculoskeletal Science and Education
	418 E. Lancaster Ave.
	Wayne, PA 19087
	Phone: 484.420.4286 x307
	Fax: 484.318.8031
Date Prepared	January 17, 2017
Device Class	Class II
Classification Name	Smooth or threaded metallic bone fixation fastener
Classification Number	21 CFR §888.3040
Classification Panel:	Orthopedic
Product Code	OUR
Reason for 510(k)	New Device
Predicate Device	Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702)
	Synthes Cannulated Screw (K021932)
	Zyga SImmetry Sacroiliac Joint Fusion System (K102907)

Indications:

The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct

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to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.

Device Description:

Predicate Device:

The predicate devices selected for this 510(k) are the X-spine Silex™ SI Joint Fusion System (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907). The subject Siconus™ SI Fixation device is substantially equivalent to the predicate devices with respect to indications, intended use, design, function, and performance.

Substantial Equivalence:

The Siconus™ SI Joint Fixation System is considered to be equivalent in safety and effectiveness (i.e., "substantially equivalent") as the predicates, the X-spine Silex™ Sl Joint Fusion System (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907). All systems utilize comparable surgical techniques. All systems include implants and instruments that are manufactured using biocompatible materials with a long history of use in orthopedic surgery.

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Performance Testing:

Mechanical tests performed indicate that the Siconus™ SI Joint Fixation System performs equally or better as compared to the predicate devices. Testing included static torsion, static bending, dynamic bending, and screw thread pullout per ASTM F2193-02 and ASTM F543-07. The results of these tests demonstrate that the subject device is equivalent or exceeds the acceptance criteria defined by equivalent tests performed on the predicate devices.

Conclusion:

Camber Spine Technologies has provided sufficient information to demonstrate the Siconus™ SI Joint Fixation System is substantially equivalent to the predicate X-Spine Silex™ Sacroiliac Fusion Device (K123702), Synthes Cannulated Screw (K021932), and Zyga SImmetry Sacroiliac Joint Fusion System (K102907) with respect to indications, intended use, design, function, and performance.

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.