The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-70mm with a diameter of 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838 and K122074.

AI/ML Overview

This 510(k) summary for the iFuse Implant System® does not contain information about specific acceptance criteria or a study demonstrating the device meets those criteria in the way typically expected for performance claims (e.g., diagnostic accuracy for AI devices).

Instead, this submission is a modification to an already cleared device, primarily for labeling and range of sizes offered. Therefore, the core of the submission relies on demonstrating substantial equivalence to existing predicate devices rather than proving new performance against specific metrics.

Here's a breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not applicable (see Explanation below)	Not applicable (see Explanation below)

Explanation: This 510(k) does not present acceptance criteria or device performance data in the traditional sense of a study designed to measure specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission's primary "acceptance criteria" is demonstrating substantial equivalence to the predicate device.

The document explicitly states: "No performance testing was required to support the modified labeling or range of sizes offered that are the subject of this 510(k)." This indicates that the FDA did not require new studies to evaluate the mechanical or clinical performance of the device beyond what was already established for its predicates. The "performance" being evaluated for this specific submission is around the modifications related to labeling and size ranges, which are deemed not to raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. As no new performance testing or clinical studies were required or conducted for this specific 510(k) submission, there is no test set or associated data provenance to report.

3. 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. No new performance testing or clinical studies were required, thus no ground truth establishment by experts for a test set was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new performance testing or clinical studies were required, thus no adjudication method for a test set was conducted.

5. 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. The iFuse Implant System® is an orthopedic implant (a physical device), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness are not relevant to this device.

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

Not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance testing or clinical studies were required for this specific 510(k) submission. For the predicate devices on which this submission relies, the "ground truth" would have been established through a combination of biomechanical testing, material characterization, and potentially clinical outcomes from prior studies, demonstrating the safety and effectiveness of the device for its intended use.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not an AI/software device that requires a training set.

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

Not applicable. This is a physical orthopedic implant, not an AI/software device that requires a training set.

Summary

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510(k) SUMMARY

iFuse Implant System®

1 2013 APR

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

Date Prepared: December 13, 2012

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:

SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074)

Intended Use

The iFuse System is intended for sacroiliac 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. There are no changes to the technological characteristics of the predicate device that are the subject of this 510(k).

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Performance Data

No performance testing was required to support the modified labeling or range of sizes offered that are the subject of this 510(k).

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.

Conclusions

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

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "HEALTH & HUMAN SERVICES-USA" are arranged in a semi-circle above the symbol, and the word "DEPART" is below the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: April 1, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

Re: K123850

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: March 1, 2013 Received: March 4, 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 misleding.

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 Rregister.

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 (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/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark NMelkerson -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 Form (Text Version)

Indications for Use

510(k) Number (if known): K123850 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 _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 1

Krishna R. As 2013.03.29 13

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.