The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroillac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients underqoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

Device Description

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in one size. The implant is manufactured from titanium alloy per ASTM F136.

The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.

AI/ML Overview

This document is a 510(k) summary for the SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System. Based on the provided text, the device itself is an implant for sacroiliac joint fusion, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI/ML performance, ground truth, experts, and multi-reader studies) is not applicable to this submission.

The 510(k) summary describes non-clinical performance testing for the physical device to demonstrate substantial equivalence to predicate devices, but it does not involve any AI/ML components or associated performance metrics.

Here's a breakdown of why each requested item is not applicable in this context:

A table of acceptance criteria and the reported device performance: This typically refers to metrics like sensitivity, specificity, AUC for AI/ML devices. For a physical implant, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and manufacturing quality. The document states "The results of these studies show the subject device is substantially equivalent to the predicate devices" for the performed mechanical tests, but does not provide specific numerical acceptance criteria or performance metrics in a table.
- Performed Tests (Physical Device):
  - Static Shear Testing
  - Dynamic Shear Testing
  - Static Pushout Testing
  - Biomechanical Cadaver Testing
  - Simulated Use Testing
Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this implant. The testing involved mechanical and cadaveric studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant for a physical implant's mechanical testing.
Adjudication method for the test set: Not applicable for a physical implant.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI/ML software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML software.
The type of ground truth used: Not applicable in the AI/ML sense. For the physical device, the "ground truth" would be established by validated biomechanical testing methods and standards.
The sample size for the training set: Not applicable. This is for AI/ML software.
How the ground truth for the training set was established: Not applicable. This is for AI/ML software.

Conclusion: The provided document is for a physical medical device (an implant) and does not describe an AI/ML powered device. Therefore, the questions tailored for AI/ML device evaluations are not pertinent to this submission. The device demonstrated substantial equivalence through non-clinical performance testing, including mechanical and biomechanical studies, against existing predicate devices.

Summary

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August 13, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a larger font size than the name.

SI-Technology, LLC % Mr. Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188

Re: K241813

Trade/Device Name: SI-Technology® SI-DESIS® X™ Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 21, 2024 Received: June 21, 2024

Dear Mr. Gracyalny:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin
O'neill -S

for

Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241813

Device Name

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

< Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date	June 19, 2024
Sponsor	SI-TECHNOLOGY, LLC320 East Vine Drive, Suite 217Fort Collins, Colorado, USA 80524
510(k) Contact	Secure BioMed EvaluationsJustin Gracyalny, MSELinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
Trade Name	SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Common Name	Sacroiliac Joint Fixation
Code-Classification	OUR21 CFR 888.3040 : Class II
PrimaryPredicate	K190230 SI-BONE, Inc. iFuse Implant System®
AdditionalPredicates	K180818 / K231944 Tenon Catamaran Sacroiliac Joint Fixation SystemK151462 SI-TECHNOLOGY® SI-DESIS® ScrewsK021932 Synthes 6.5mm Cannulated Screw
DeviceDescription	The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion Systemconsists of an X shaped implant designed to assist in the healing of sacroiliac(SI) joints for fusion by providing fixation of the sacroiliac joint. The implantis not intended to replace normal body structures. The implant is offered in onesize. The implant is manufactured from titanium alloy per ASTM F136.The SI-TECHNOLOGY® SI-DESIS® XTM Sacroiliac Joint Fusion Systemwas designed as a less invasive alternative to traditional open posterior surgicalSI joint fusion. The titanium implant consists of a sacrum engaging side and anilium engaging side connected by a bridge. During the procedure, bone graftmaterial is placed in the window of the implant to facilitate stabilization. Theimplant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
Indications forUse	The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint FusionSystem is intended for sacroiliac fusion for conditions including sacroiliacjoint dysfunction that is a direct result of sacroiliac joint disruption anddegenerative sacroiliitis. This includes conditions whose symptoms beganduring pregnancy or in the peripartum period and have persistedpostpartum for more than 6 months.The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion Systemis also intended for sacroiliac fusion to augment immobilization andstabilization of the sacroiliac joint in skeletally mature patients undergoingsacropelvic fixation as part of a lumbar or thoracolumbar fusion.
TechnologicalCharacteristics	There are no significant technological differences between the subject andpredicate devices. The technological design features of the subject implantswere compared to the predicates in intended use, indications for use, design,function and technology and it was demonstrated that they are substantiallyequivalent.
PerformanceTesting	Non-clinical testing was performed to demonstrate the subject device issubstantially equivalent to other predicate devices. The following tests wereperformed to show equivalency:• Static Shear Testing• Dynamic Shear Testing• Static Pushout Testing• Biomechanical Cadaver Testing• Simulated Use TestingThe results of these studies show the subject device is substantiallyequivalent to the predicate devices.
Conclusions	Based on the indications for use, technological characteristics, performancetesting, and comparison to the predicate device, the subject device is as safeand as effective as the legally marketed predicates.

510(k) Summary: SI-TECHNOLOGY® SI-DESIIS® XTM

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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.