The Integrity-SI™ Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The Integrity-SI™ Fusion System consists of partially and fully threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per ASTM F136) implants designed to be inserted across sacroiliac joint to provide stability for joint arthrodesis. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in and partially and fully threaded versions in lengths ranging from 40-110mm, in 5mm increments. All screw sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary screws are offered from lengths of 30 - 70 mm, in 5mm increments. All implants are provided sterile and are individually packaged. The 6.5 mm screws are not for use without the subject 10 mm or 12 mm screws.

AI/ML Overview

The provided document describes the mechanical testing and substantial equivalence determination for the "Integrity-SI™ Fusion System". This is a medical device (sacroiliac joint fixation fastener) and not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, ground truth, and training set details are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance related to the mechanical testing described in the document.

Acceptance Criteria and Reported Device Performance

The document states that "Testing was performed for the Integrity-SI™ Fusion System and demonstrated substantially equivalent performance to the identified predicates." The acceptance criterion for this device appears to be demonstrating substantial equivalence in mechanical performance to the predicate devices and the ability to withstand expected loading without failure.

The document lists the following mechanical tests performed and the general findings:

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
Torsional strength/breaking angle	Substantially equivalent to predicates; capable of withstanding expected loading.	Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure.
Insertion/removal torque	Substantially equivalent to predicates; capable of withstanding expected loading.	Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure.
Pullout force	Substantially equivalent to predicates; capable of withstanding expected loading.	Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure.
Static Bending Strength	Substantially equivalent to predicates; capable of withstanding expected loading.	Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure.
Fatigue Bending Strength	Substantially equivalent to predicates; capable of withstanding expected loading.	Demonstrated substantially equivalent performance to identified predicates. Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure.
Cadaveric testing (surgical technique)	Device can be safely implanted using the surgical technique.	Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique.

N/A for AI/ML Specific Questions:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a mechanical medical device, not an AI/ML system. The "test set" here refers to the physical devices undergoing mechanical testing, not a dataset.
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 based on engineering standards and measurements, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical tests would be defined by the specifications and measurement techniques outlined in the referenced ASTM standards (e.g., ASTM F543-13e1, ASTM F2193-14).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health, represented by a staff with two snakes coiled around it.

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

December 14, 2016

CoorsTek Medical LLC Mr. Steve Brown QA/RA Manager 560 West Golf Course Road Providence, Utah 84332

Re: K161755

Trade/Device Name: Integrity-SI"M 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: November 17, 2016 Received: November 18, 2016

Dear Mr. Steve Brown:

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 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.

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

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}------------------------------------------------

Indications for Use

510(k) Number (if known) K161755

Device Name Integrity-SI Fusion System

Indications for Use (Describe)

The Integrity-SI Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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

Image /page/3/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" part in red and the "TEK" part in black. Below "CoorsTek" is the word "MEDICAL" in smaller, black letters. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.

Section 4: 510(k) SUMMARY [As required by 21 CFR 807.92 (c)]

Submitter / Contact Person / Date of Preparation

Submitter/Sponsor	CoorsTek Medical LLC560 W. Golf Course Rd.Providence, UT 84332Phone: 435-774-1535Fax: 435-753-7698
Contact Person	Steve Brown
Date of preparation	December 9th, 2016

General Information

Trade Name	Integrity-SI™ Fusion System
Common / Usual Name	Sacroiliac Joint Fixation - Smooth or threaded metallic bone fixation fastener
Classification Name and Number	Sacroiliac Joint Fixation, 888. 3040
Regulatory Class	Class II
Device Regulation Panel	Orthopedics
Product Code	OUR
Manufacturer	CoorsTek Medical LLC560 W. Golf Course Rd.Providence, UT 84332
Identification of LegallyMarketed PredicateDevices	Synthes 6.5 mm Cannulated Screw (K021932) Zyga Technology SImmetry® Sacroiliac Joint Fusion System (K141549) Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472)

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

Image /page/4/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "Coors" is in red, and the word "Tek" is in black. The word "Medical" is in smaller black font below the word "Tek".

Device Description	The Integrity-SITM Fusion System consists of partially and fullythreaded, self-tapping cannulated titanium (Ti-6Al-4V ELI perASTM F136) implants designed to be inserted across sacroiliacjoint to provide stability for joint arthrodesis. The surgical implantsare available in various sizes to accommodate patient anatomy.The 10mm and 12mm diameter screws are offered in and partiallyand fully threaded versions in lengths ranging from 40-110mm, in5mm increments. All screw sizes are available in non-coated orhydroxyapatite-coated (HA) versions. The 10mm and 12mmscrews also include a pre-assembled washer for improved jointcompression. The fully threaded 6.5mm diameter, optionalsecondary screws are offered from lengths of 30 - 70 mm, in 5mmincrements. All implants are provided sterile and are individuallypackaged. The 6.5 mm screws are not for use without the subject10 mm or 12 mm screws.
Intended Use	The system is used to provide structural stability in skeletallymature individuals who have developed a clinical need to alleviatechronic pain due to SI joint disruptions and degenerativesacroiliitis.
Indications for Use	Integrity-SITM Fusion System is intended for sacroiliac joint fusionfor conditions including sacroiliac joint disruptions anddegenerative sacroilitis.
Indications for UseComparison	The intended use for the subject and predicate devices are thesame. The indications for use statement for the subject deviceand the Zyga Technology Simmetry (K021932) and MedtronicSofamor Danek MSB Sacroiliac Joint Fusion Device (K110472)predicates are identical. The Synthes 6.5 mm Cannulated Screw(K021932) indications for use statement is broader than thesubject device but does include SI joint disruptions.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" in red and the "Tek" in black. Below the word "CoorsTek" is the word "Medical" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's website and marketing materials.

Summary of Non-ClinicalPerformance Data	Testing was performed for the Integrity-SI™ Fusion System anddemonstrated substantially equivalent performance to theidentified predicates. The following mechanical tests wereperformed: Torsional strength/breaking angle (ASTM F543-13e1) Insertion/removal torque (ASTM F543-13e1) Pullout force (ASTM F543-13e1) Static Bending Strength (ASTM F2193-14) Fatigue Bending Strength (ASTM F2193-14) Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique.
TechnologicalCharacteristicsComparison	The technological characteristics and intended use of the subject devices is identical to that of the predicate devices cleared under the following submissions: K141559 Slmmetry Sacroiliac Joint Fusion System K110472 Medtronic Sacroiliac Fusion Device K021932 Synthes 6.5mm Cannulated Screw Both subject and predicate devices include titanium alloy bone screws that are inserted across the SI joint to provide a stable construct to promote arthrodesis across the joint. As a result, the subject device does not introduce any new concerns of safety or effectiveness.
Conclusion	Based upon a comparison of the design features, indications for use, technological characteristics, the use of established well known materials, and mechanical performance, the Integrity-SI™ Fusion System has demonstrated substantial equivalence to the identified predicate device systems. The performance data demonstrates that the devices included in the Integrity-SI™ Fusion System do not raise any new questions of safety or effectiveness.

Summary of Non-ClinicalPerformance Data

Testing was performed for the Integrity-SI™ Fusion System anddemonstrated substantially equivalent performance to theidentified predicates. The following mechanical tests wereperformed: Torsional strength/breaking angle (ASTM F543-13e1) Insertion/removal torque (ASTM F543-13e1) Pullout force (ASTM F543-13e1) Static Bending Strength (ASTM F2193-14) Fatigue Bending Strength (ASTM F2193-14) Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique.

TechnologicalCharacteristicsComparison

The technological characteristics and intended use of the subject devices is identical to that of the predicate devices cleared under the following submissions: K141559 Slmmetry Sacroiliac Joint Fusion System K110472 Medtronic Sacroiliac Fusion Device K021932 Synthes 6.5mm Cannulated Screw Both subject and predicate devices include titanium alloy bone screws that are inserted across the SI joint to provide a stable construct to promote arthrodesis across the joint. As a result, the subject device does not introduce any new concerns of safety or effectiveness.

Conclusion

Based upon a comparison of the design features, indications for use, technological characteristics, the use of established well known materials, and mechanical performance, the Integrity-SI™ Fusion System has demonstrated substantial equivalence to the identified predicate device systems. The performance data demonstrates that the devices included in the Integrity-SI™ Fusion System do not raise any new questions of safety or effectiveness.

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.