The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838, K122074 and K123850.

AI/ML Overview

The provided text is a 510(k) summary for the iFuse Implant System®, and it primarily discusses substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and a detailed analysis of device performance. The only "performance data" mentioned is related to MR compatibility.

Therefore, an extensive table of acceptance criteria and reported device performance, information about sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, training set details, or specific types of ground truth cannot be extracted from this document as these types of studies were not included in the submission.

Here's a summary of the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Magnetic Resonance (MR) Imaging Compatibility: Compatibility and safety under typical MR conditions, following aspects of ASTM F2052-06, ASTM F2182-11A, and ASTM F2119-07.	The iFuse Implant is MR conditional and labeled in compliance with ASTM F2503-08.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is detailed as "Magnetic resonance (MR) imaging testing."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not specified. The document states "Magnetic resonance (MR) imaging testing was performed" but does not give details about the number of implants or test conditions.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The MR imaging testing does not involve establishing ground truth through expert review in the way a diagnostic imaging study would. The ground truth for MR compatibility testing lies in meeting specific standards through physical testing.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which is not the nature of MR compatibility testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not performed. The data presented relates to MR compatibility, not clinical effectiveness studies comparing human readers with or without AI assistance.

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

Not applicable. This device is an implant, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance refers to the physical properties of the implant under MR conditions.

7. The Type of Ground Truth Used:

The ground truth for the MR compatibility testing is based on the standards themselves (ASTM F2052-06, ASTM F2182-11A, ASTM F2119-07, and ASTM F2503-08). Meeting these objective, predefined standards through physical testing constitutes the "ground truth" for MR safety and compatibility.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, and therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set.

Summary

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510(k) SUMMARY

iFuse Implant System®

510(k) Owner's Name, Address, and Telephone Number SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 (408) 207-0700

Contact Person

Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to SI-BONE, Inc. Email: domecusconsulting@comcast.net Phone: 650-343-4813 Mobile: 650-773-3445 Facsimile: 650-343-7822

OCT 1 6 2013

Date Prepared: October 4, 2013

Trade Name of Device: iFuse Implant System®

Common or Usual Name: Orthopedic Rod

Classification Name:

21 C.F.R. 888,3040 - Smooth or threaded metallic bone fastener; Product Code OUR

Predicate Devices:

iFuse Implant System® by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850) Pioneer Cannulated Screw System by Pioneer Surgical Technology (K102903)

Intended Use

The iFuse System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

Technological Characteristics

The iFuse Implant System® consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone to create fixation/stabilization and

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K131405 (pg 2/2)

fusion. There are no changes to the technological characteristics of the predicate device that are the subject of this 510(k).

Performance Data

Magnetic resonance (MR) imaging testing was performed to assess the compatibility and safety under typical MR conditions following aspects of ASTM F2052-06, ASTM F2182-11A and ASTM F2119-07. The iFuse Implant is MR conditional and labeled in compliance with ASTM F2503-08.

Substantial Equivalence

The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, the iFuse Implant System is substantially equivalent to the predicate device.

Further, the proposed longer device length is substantially equivalent to the Pioneer Cannulated Screw System manufactured by Pioneer Surgical Technology (Class II, Product Codes HWC, OUR; 21 CFR 888.3040).

Conclusions

The iFuse Implant System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

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

October 16, 2013

SI-BONE, Incorporated % Ms. Cindy Domecus Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K131405

Trade/Device Name: SI-BONE iFuse Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: September 18, 2013 Received: September 19, 2013

Dear Ms. Domecus:

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

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Page 2 - Ms. Cindy Domecus

forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Erin] ( Erin Erin

for

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): K131405 (pg 1/1)

Device Name: SI-BONE iFuse Implant System

Indications for Use:

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.