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.

Device Description

The iFuse Implant System consists of cannulated triangular, titanium (Ti 6A1 4V ELI, ASTM F136/F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the SI joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters, and are provided sterile (gamma sterilization). Fenestrations allow packing of autograft and/or allograft material.

AI/ML Overview

The provided text is a 510(k) summary for the iFuse Implant System® - iFuse-3D implant. It describes a medical device, its intended use, and its comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, the document does not contain information related to a study proving a device meets acceptance criteria via a performance study involving AI or human readers, nor does it describe specific acceptance criteria and reported device performance in the context of an AI-assisted diagnostic or assistive device. It primarily discusses mechanical, biocompatibility, and sterilization testing for an implantable device to demonstrate substantial equivalence to existing devices.

Therefore, without the requested information in the provided input, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI or diagnostic device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

A table of acceptance criteria and the reported device performance: The document mentions "performance testing" but it refers to mechanical (static and fatigue bending, pull-out), MR safety, LAL (endotoxin), and biocompatibility testing for an implantable bone fastener. It does not provide specific performance metrics or acceptance criteria for a diagnostic/AI device.
Sample sized used for the test set and the data provenance: Not applicable or provided for an AI system. The "test set" here refers to physical implants undergoing mechanical and other lab tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant is typically established through material science standards, engineering specifications, and biological safety assessments, not expert image interpretation.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This study focuses on an implantable device, not a diagnostic or AI-assisted interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this medical device (an implant), ground truth relates to material properties, structural integrity, biocompatibility, and sterility, verified through laboratory testing.
The sample size for the training set: Not applicable. This document is not about an AI model with a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes regulatory approval for a physical medical implant (iFuse Implant System® - iFuse-3D implant) and uses laboratory and mechanical testing to demonstrate substantial equivalence. It does not contain any information about an AI-powered diagnostic device, its performance studies, or related acceptance criteria.

Summary

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

March 10, 2017

SI-BONE, Inc. Roxanne Dubois VP, Regulatory and Quality 3055 Olin Ave, Suite 2200 San Jose, California 95128

Re: K162733

Trade/Device Name: iFuse Implant System® - iFuse-3D implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 31, 2017 Received: February 2, 2017

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 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.

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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

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Indications for Use Statement

510(k) Number (if known): K162733

Device Name: iFuse Implant System® - iFuse-3D implant

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.

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510(k) SUMMARY - iFuse Implant System®

I. SUBMITTER

SI-BONE, Inc. 3055 Olin Avenue, Suite 2200, San Jose, CA 95128 Phone: (408) 207-0700; Fax: 408-557-8312 Contact Person: Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. Email: rdubois@si-bone.com Mobile: 408-828-5019; Office: 408-207-0700 x2236 Date Prepared: March 9, 2017

II. DEVICE

Trade Name of Device:	iFuse Implant System® - iFuse-3D implant
Common or Usual Name:	Sacroiliac Joint Fixation
Regulation Number:	21 CFR 888.3040 – Smooth or threaded metallic bone fastener
Product Code:	OUR; Sacroiliac Joint Fixation

III. PREDICATE DEVICES

Primary Predicate:	iFuse Implant System by SI-BONE, K160652
Reference Predicate:	Synthes Cannulated Screw, K021932Spine Frontier, K150017

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

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pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

VI. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THEPREDICATE

The iFuse Implant System consists of manual instruments and a series of triangular titanium implants intended for surgical implantation across the sacroiliac joint to create immediate stabilization and fusion. The proposed implant is additively manufactured.

VII. PERFORMANCE DATA

Performance testing was conducted to support the design and development of the proposed implant including mechanical testing, simulated use testing, and biocompatibility testing. The mechanical testing included static and fatigue bending testing, as well as pull-out testing of the finished device. Additionally, MR safety testing to establish that the device is MR conditional was conducted as well as Limulus amebocyte lysate (LAL) testing to establish that the device meets the specified 20 EU/device limit. The test results show that the exhibited characteristics are comparable to the predicate and reference devices. The interconnected porous surface was found to have comparable porosity and mechanical characteristics compared to the predicates and acceptable performance in a simulated use test. Characterization of the porous structure was performed. The device was also found to be MR conditional, non-pyrogenic and biocompatible. The performance tests demonstrate that the device is as safe, as effective and performs at least as well as the legally marketed devices identified in Section III. Validation tests included printing validation (e.g. build parameters), powder bed recycling validation and cleaning validation.

VIII. CONCLUSIONS

The intended use is unchanged compared to the predicate devices and the verification and validation results, technological characteristics, and the performance data support that the proposed implants are substantially equivalent to the predicate devices. The performance data also demonstrate that the device is as safe, as effective and performs at least as well as the legally marketed devices identified in Section III.

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.