The SI-Bone SI Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The SI Fusion System consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone, to create fixation. Their intended use is for fracturc fixation of large bones and large bone fragments of the pelvis for such conditions as sacroiliac joint disruptions and degenerative sacroiliitis. The system includes 7.0 mm fusion rods, which range in length from 30 mm to 70 mm.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Device Performance
Axial pullout resistance substantially similar to predicate devices	Bench-top testing demonstrated substantial similarity to predicate devices
Stability in dynamic cantilever bending substantially similar to predicate devices	Bench-top testing demonstrated substantial similarity to predicate devices
Fixation of SI joint substantially similar to predicate devices	Finite Element Analysis (FEA) and bench-top testing results support substantial similarity

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in the provided text for the bench-top testing. The text refers to "bench-top testing" and a "study" in general terms.
Data Provenance: Not explicitly stated. The testing appears to be conducted by the company (SI-Bone, Inc.) and is likely proprietary. There is no mention of country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The performance data presented is based on engineering analyses and bench-top mechanical testing, not on human expert assessment of a test set. Therefore, no experts were used to establish ground truth in the traditional sense of clinical or image-based studies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which is not the nature of the performance data described (FEA and bench-top biomechanical testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The performance data focuses on the mechanical properties and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

The ground truth for the performance assessment was based on:

Engineering principles and models: For the Finite Element Analysis (FEA).
Physical measurements and biomechanical testing standards: For the bench-top testing of axial pullout resistance and dynamic cantilever bending. The "ground truth" is essentially the established mechanical properties and performance of the predicate devices.

8. The sample size for the training set:

This information is not applicable. The SI-Bone SI Joint Fusion System is a hardware device (metallic rods); it is not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a hardware device.

Summary

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510(k) SUMMARY

SI-Bone, Inc.'s SI Joint Fusion System

Submitter's Name, Address, Telephone Number

NOV 2 6 2008

SI-Bone, Inc. 15370 Pepper Lane Saratoga, CA 95070 USA

Contact Person: Jeff Dunn President/CEO SI-Bone, Inc. 15370 Pepper Lane Saratoga, CA 95070
November 20, 2008 Date Prepared:
SI Joint Fusion System Name of Device:

Common or Usual Name: Orthopedic Rods

Classification Name: 21 CFR 888.3040 - Smooth or threaded metallic bone fastener

Predicate Devices:

Synthes (USA) 6.5 mm Cannulated Screw (K021932) Reiley Orthopedics ROI Fusion Rods and Plates (K051309) SIJF Cannulated Screw System (K051296)

Intended Use:

The SI-Bonc SI Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

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K080340 pg 22

Performance Data

A Finite Element Analysis (FEA) was performed on the SI Fusion System in comparison to its predicate. In addition, the company has conducted bench-top testing of axial pullout resistance and stability in dynamic cantilever bending. The results demonstrate that the SI Fusion Rod is substantially similar to the predicate devices with respect fixation of the SI joint.

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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 consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

SI-Bone, Inc. % Mr. Jeffery Dunn 15370 Pepper Lane Saratoga, California 95070

APR 1 5 2011

Re: K080398

Trade/Device Name: SI-Bone SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: OUR Dated: October 24, 2008 Received: October 24, 2008

Dear Mr. Dunn:

This letter corrects our substantially equivalent letter of November 26, 2008.

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

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Page 2 - Mr. Jeffery Dunn

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Pete Thomas
DEP DA

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): K080398

Device Name: ST-Bone SI Joint Fusion System

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ___ of __________________________________________________________________________________________________________________________________________________________________

Mark A. Millkern

(Division Sign-Off) (Division Sigu-On)
Division of General, Restorative, and Neurologi

510(k) Number

WDC - 0225154000001 - 2767199 w

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.