The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

Device Description

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 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714 and K150875.

AI/ML Overview

Here's an analysis of the provided text regarding the iFuse Implant System and its acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state specific numerical acceptance criteria for the device's performance that would typically be seen in an AI/software device submission (e.g., Sensitivity > X%, Specificity > Y%). Instead, the submission focuses on clinical endpoints related to patient outcomes, consistent with a medical implant.

The reported device performance is described qualitatively and through the mention of improvement in specific clinical measures.

Criterion Type	Acceptance Criteria (as implied)	Reported Device Performance
Clinical Efficacy (Pain)	Implied: Demonstrate statistically significant improvement in SI joint pain.	INSITE Study: At both 6 and 12 months, showed improvement in SI joint pain in the iFuse implant group compared to the control group. SIFI Study: Showed improvements in SI joint pain compared to baseline findings. (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain... at 12 months post-implantation.")
Clinical Efficacy (Function)	Implied: Demonstrate statistically significant improvement in patient function/disability due to lower back/SI joint pain.	INSITE Study: At both 6 and 12 months, showed improvement in disability due to lower back pain in the iFuse implant group. SIFI Study: Showed improvements in disability due to SI joint pain compared to baseline findings. (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved... patient function... at 12 months post-implantation.")
Clinical Efficacy (QoL)	Implied: Demonstrate statistically significant improvement in quality of life.	INSITE Study: At both 6 and 12 months, showed improvement in quality of life (by two measures) in the iFuse implant group. SIFI Study: Showed improvements in quality of life (by two measures) compared to baseline findings. (The document states "Clinical studies have demonstrated that treatment with the iFuse Implant System improved... quality of life at 12 months post-implantation.")
Safety	Not explicitly stated as a separate criterion, but inherent in clinical trials for medical devices. The 510(k) process focuses on substantial equivalence to a predicate device, which implies an acceptable safety profile similar to the predicate. No specific safety data or adverse event rates are provided in this summary, but they would have been part of the full 510(k) submission. No new safety concerns were identified that would affect substantial equivalence.	The submission claims "no changes to the technological characteristics of the device" which likely implies the safety profile remains consistent with previous versions. The 510(k) determination itself implies that the FDA found the device to be substantially equivalent to predicates in terms of safety and effectiveness.

2. Sample Sizes Used for the Test Set and Data Provenance

INSITE Study (Prospective Randomized Controlled Trial):
- Total Patients: 148
- iFuse Implant System Group: n=102
- Non-Surgical Management (Control Group): n=46
- Provenance: Prospective study. Country of origin not specified, but typically multi-center studies for FDA submissions include sites in the US and potentially other regions.
SIFI Study (Prospective Multicenter Single-Arm Clinical Trial):
- Total Patients: 172
- Provenance: Prospective, multicenter study. Country of origin not specified.
Retrospective Studies: Mentioned as contributing data, but no specific sample sizes or details are provided in this summary.

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

This information is not applicable in the context of this device submission. The iFuse Implant System is a physical medical device (implantable fusion rod), not an AI/imaging diagnostic device that relies on human experts to establish "ground truth" for image interpretation or algorithmic output in a test set. The "ground truth" for this device's effectiveness is established through clinical outcomes (pain, function, quality of life) measured directly from patients in clinical trials.

4. Adjudication Method for the Test Set

This information is also not directly applicable as it relates to expert review of data, typically for image interpretation or diagnostic accuracy. For the clinical trials (INSITE, SIFI), the "adjudication" would involve:

Study Design: Blinding (in INSITE, participants were assigned to groups, but assessments like pain scales are patient-reported).
Statistical Analysis: Used to compare outcomes between groups or against baseline.
Independent Review Boards/Ethics Committees: Oversee the conduct of the studies.
Clinical Endpoints: Defined measurements (e.g., VAS pain scores, Oswestry Disability Index, SF-36) are collected systematically from patients.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic imaging devices where multiple readers evaluate cases with and without the assistance of an AI system. The iFuse Implant System is a therapeutic device, not a diagnostic one.

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

No, this question is not applicable. The iFuse Implant System is a physical medical implant, not an algorithm or AI system. Its performance is evaluated through its direct therapeutic effect on patients.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness of the iFuse Implant System is based on patient-reported outcomes and objective clinical measures from the prospective clinical studies (INSITE and SIFI). These include:

Pain levels: Likely measured using validated scales (e.g., Visual Analog Scale - VAS).
Patient Function/Disability: Likely measured using validated scales (e.g., Oswestry Disability Index, Roland-Morris Disability Questionnaire).
Quality of Life: Measured using validated instruments (e.g., SF-36).

For a device like this, these clinical outcomes are the primary indicators of "ground truth" regarding its efficacy.

8. The Sample Size for the Training Set

No information regarding a "training set" is applicable or provided in this 510(k) summary. "Training set" is a term used in the development of AI/machine learning algorithms. The iFuse Implant System is a physical device, and its development and validation do not involve machine learning training sets in the traditional sense.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. There is no training set as it's a physical medical device, not an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

October 29, 2015

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

SI-BONE, Incorporated Ms. Roxanne Dubois Vice President, Regulatory Affairs and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128

Re: K151718

Trade/Device Name: 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: October 1, 2015 Received: October 2, 2015

Dear Ms. Dubois:

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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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/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 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 yours,

Mark N. Melkerson -S

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 STATEMENT

K151718 510(k) Number (if known):

Device Name: SI-BONE iFuse Implant 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 1 of ____________________________________________________________________________________________________________________________________________________________________

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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

Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. Email: rdubois@si-bone.com Mobile: 408-828-5019; Office: 408-207-0700; Facsimile: 408-557-8312

Date Prepared: October 28, 2015

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, K131405, K141049, K150714, K150875)

Intended Use

Device Description

Technological Characteristics

The iFuse Implant System® consists of a series of metallic (titanium), porous plasma sprav coated rods, intended for surgical implant within the bone to create biological fixation, immediate stabilization and fusion. This 510(k) does not involve any changes to the technological characteristics of the device.

Performance Data

No performance testing was required to support the modified labeling that is the subject of this 510(k).

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Clinical Tests

Data to support claims of improvement in pain, disability and quality of life at 12 months post-implantation come from prospective and retrospective studies. Prospective studies included INSITE (Investigation of Sacroiliac Fusion Treatment) and SIFI (Sacroiliac Joint Fusion with iFuse Implant System). INSITE is a prospective randomized controlled trial of 148 patients with sacroiliac joint dysfunction assigned to either sacroiliac (SI) joint fusion with iFuse Implant System (n=102) or non-surgical management (NSM, n=46, control group). At both 6 and 12 months, INSITE study data showed improvement in SI joint pain, disability due to lower back pain, and quality of life (by two measures) in the iFuse implant group. SIFI is a prospective multicenter single-arm clinical trial of 172 patients. SIFI data showed improvements in SI joint pain, disability due to SI joint pain, and quality of life (by two measures) compared to baseline findings. The improvements in SIFI and INSITE were very similar. Follow-up to 24 months is planned but is not completed for all of the enrolled patients.

Substantial Equivalence and Conclusion

The iFuse Implant System is substantially equivalent to the predicate device (iFuse Implant System).

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.