SICAGE is a fully threaded bone screw offered in a single diameter and various lengths to accommodate variability in patient anatomy. SICAGE is sold sterile. The SICAGE System includes implants and instruments for implantation.

AI/ML Overview

This document is a 510(k) premarket notification for the SICAGE™ System, a fully threaded bone screw intended for sacroiliac joint fusion. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study on acceptance criteria for an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and testing is not applicable.

Here's an attempt to answer the questions based on the provided text, recognizing its limitations for AI/ML criteria:

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

Since this is a mechanical medical device (a bone screw), the "acceptance criteria" and "reported device performance" are based on mechanical testing standards, not AI/ML metrics like sensitivity, specificity, or accuracy.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Meets Torsion Strength per ASTM F543	SICAGE System demonstrated performance substantially equivalent to predicate devices for torsion.
Meets Pullout Strength per ASTM F543	SICAGE System demonstrated performance substantially equivalent to predicate devices for pullout.
Meets Static Bending Strength per ASTM F2193	SICAGE System demonstrated performance substantially equivalent to predicate devices for static bending.
Meets Dynamic Bending Strength per ASTM F2193	SICAGE System demonstrated performance substantially equivalent to predicate devices for dynamic bending.
Material Properties per ASTM F136 (Ti-6Al-4V ELI titanium alloy)	SICAGE bone screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136), meeting material requirements.
Design/Dimensions similar to predicate devices	Sizes (dimensions are comparable to those offered by the predicate systems)

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 as this is mechanical testing of a device, not a data-driven clinical study with human subjects. The "test set" would refer to the number of screws and test repetitions.
Data Provenance: Not applicable in the context of mechanical device testing. The results are from laboratory testing.

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 for mechanical testing is established by adherence to recognized ASTM standards and measurement results, not expert consensus.

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

Not applicable. Mechanical testing involves standardized procedures and objective measurements, not subjective adjudication.

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 device is a bone screw, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a bone screw.

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

The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F543, ASTM F2193). The performance is assessed against these established engineering and material requirements.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

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

Not applicable. (See #8)

Summary

{0}------------------------------------------------

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

Sicage LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026-0566 May 5, 2017

Re: K170475

Trade/Device Name: SICAGETM System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: February 14, 2017 Received: February 16, 2017

Dear Dr. Warden:

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

{1}------------------------------------------------

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 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 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.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

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 on last page.

510(k) Number (if known)

K170475

Device Name SICAGE™ System

Indications for Use (Describe)

SICAGE is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis.

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

区 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)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

Date:	14 February 2017
Sponsor:	Sicage LLC
	6709 S. Minnesota Ave, Suite 206Sioux Falls, SD 57108
Sponsor Contact:	Kristi Vondra, VP of Operations
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.
	PO Box 566
	Chesterland, OH 44026
	Office: 440.729.8457
Proposed Trade Name:	SICAGE™ System
Common Name:	Cannulated bone screw
Regulatory Class:	Class II
Regulation Name,Regulation Number,Product Codes:	Smooth or threaded metallic bone fixation fastener, 21 CFR 888.3040, OUR
Device Description:	SICAGE is a fully threaded bone screw offered in a single diameter andvarious lengths to accommodate variability in patient anatomy. SICAGE issold sterile. The SICAGE System includes implants and instruments forimplantation.
Indications for Use:	SICAGE is intended for sacroiliac joint fusion for conditions includingsacroiliac joint disruptions and degenerative sacroiliitis.
Materials:	The SICAGE bone screws are manufactured from titanium alloy (Ti-6Al-4VELI per ASTM F136).
Primary Predicate:	Synthes 6.5mm Cannulated Screw (Synthes (USA) – K021932)
Additional Predicate:	Silex Sacroiliac Joint Fusion System (X-Spine Systems - K123702)
Performance Data:	Mechanical testing of worst case SICAGE System screws included torsionand pullout per ASTM F543 and static and dynamic bending per ASTMF2193.The mechanical test results demonstrated that SICAGE Systemperformance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The SICAGE System possesses the same technological characteristics asone or more of the predicate devices. These include:• intended use (as described above)• basic design (threaded bone screw),• material (titanium alloy) and• sizes (dimensions are comparable to those offered by the predicate systems)The fundamental scientific technology of the SICAGE System is the sameas previously cleared devices.
Conclusion:	The SICAGE System possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore SICAGE System issubstantially equivalent for its intended use.

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.