· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

Device Description

The iFuse TORQ Implant System consists of the iFuse TORQ Implants and associated Instruments. Implants are threaded, fenestrated, cannulated, 3D-printed from medical grade titanium alloy (Ti-6A1-4V ELI per ASTM F3001). The implants are fully threaded or a lag design that is provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-the-shelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

This 510(k) covers extension of the porous lattice surface over the entire shank of the Ø10.0 mm screws, an optimized laser path during additive manufacturing process, and use of two implants in the SAI (posteromedial) trajectory for sacroiliac joint fusion.

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device (iFuse TORQ® Implant System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) are not applicable in this context.

The document discusses acceptance criteria and studies for the mechanical and material properties of the iFuse TORQ® Implant System, which is a physical implant for sacroiliac joint fusion and fracture fixation.

Here's the information relevant to the provided document, based on the non-AI device context:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. Instead, it lists the types of performance tests conducted and then concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device." This implies that the performance in these tests met the established criteria for substantial equivalence to the previously cleared predicate device.

Test Type	Standard Used	Reported Performance
Porosity testing	ASTM F1854	Results demonstrate substantial equivalence to the predicate device, indicating suitable porous lattice surface characteristics.
Static Shear	ASTM F1044	Results demonstrate substantial equivalence to the predicate device, indicating adequate shear strength.
Static Fatigue	ASTM F1160	Results demonstrate substantial equivalence to the predicate device, indicating adequate fatigue resistance.
Static Tensile	ASTM F1147	Results demonstrate substantial equivalence to the predicate device, indicating adequate tensile strength.
Abrasion	ASTM F1978	Results demonstrate substantial equivalence to the predicate device, indicating adequate abrasion resistance.
Dynamic Cantilever Testing	ASTM F2193	Results demonstrate substantial equivalence to the predicate device, indicating adequate dynamic load bearing.
Static Torsion Testing	ASTM F543	Results demonstrate substantial equivalence to the predicate device, indicating adequate torsional strength.

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes (number of implants tested) used for each of the listed bench tests.
Data Provenance: The tests are "bench testing," meaning they are conducted in a laboratory setting, not with human or animal data. The provenance is internal laboratory testing by the manufacturer (SI-BONE Inc.) or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the studies are mechanical bench tests, not clinical studies reviewed by medical experts. The "ground truth" is defined by the physical properties and engineering standards (ASTM).

4. Adjudication method for the test set:

This question is not applicable as the studies are mechanical bench tests, not clinical studies requiring adjudication. The results are quantitative measurements against established engineering standards.

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:

This question is not applicable. This device is a physical implant, not an AI/ML diagnostic or assistive tool.

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

This question is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For the performance data, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for material and mechanical testing of medical implants. The goal is to demonstrate that the modified device performs similarly to or better than the predicate device under these standardized conditions.

8. The sample size for the training set:

This question is not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

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

This question is not applicable. As above, there's no training set for a physical implant.

Summary of what the K241574 document does provide regarding acceptance and proof:

The document describes modifications to an existing device (iFuse TORQ® Implant System). The acceptance criteria for these modifications, and the proof that they are met, revolve around demonstrating that the modified device is substantially equivalent to its predicate device(s) in terms of safety and effectiveness.

This is primarily shown through:

Bench Testing: Mechanical and material tests (Porosity, Static Shear, Static Fatigue, Static Tensile, Abrasion, Dynamic Cantilever, Static Torsion) were performed according to recognized ASTM standards.
Conclusion of Equivalence: The submission concludes that "The test results demonstrate that the device is substantially equivalent to the predicate device" and that "The differences in the technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness."

The FDA's clearance letter confirms this conclusion, stating that the device is "substantially equivalent... to legally marketed predicate devices."

Summary

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July 2, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SI-BONE Inc. Robyn Capobianco VP Clinical and Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050

Re: K241574

Trade/Device Name: iFuse TORQ® Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC, OLO Dated: May 31, 2024 Received: June 3, 2024

Dear Robyn Capobianco:

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 QS 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 mediation-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,

Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.07.02
14:56:32 -04'00'
for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241574

Device Name iFuse TORQ® Implant System

Indications for Use (Describe)

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.

· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

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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510(K) SUMMARY- iFuse TORQ® Implant System

Date Prepared: May 31, 2024

I. SUBMITTER

SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: 408-207-0700 Fax: 408-557-8312

Contact Person: Robyn Capobianco, VP Clinical & Regulatory Affairs Email: robyn.capobianco(@si-bone.com Phone: 650-219-8342

II. DEVICE

Trade Name of Device:	iFuse TORQ® Implant System
Common or Usual Name:	Sacroiliac Joint Fixation
Classification:	II
Regulation Number:	21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
Product Codes:	OUR, HWC, OLO

III. PREDICATE DEVICE

Primary Predicate:	iFuse TORQ Implant System (K222605)
Additional Predicates:	iFuse TORQ Implant System (K231689)
iFuse Bedrock Granite Implant System (K220195)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The iFuse TORO Implant System is indicated for sacroiliac joint fusion for:

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iFuse TORQ Implant System

Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
. Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modifications to the subject implant screws do not alter the device's fundamental scientific technology compared to the predicate. Risk analyses and performance data confirm that the proposed changes do not raise different questions of safety and effectiveness.

VII. PERFORMANCE DATA

All necessary bench testing was conducted on the modified iFuse TORQ implants including:

Porosity testing per ASTM F1854
Static Shear per ASTM F1044 ●
Static Fatigue per ASTM F1160
. Static Tensile per ASTM F1147
. Abrasion per ASTM F1978
Dynamic Cantilever Testing per ASTM F2193
Static Torsion Testing per ASTM F543

The test results demonstrate that the device is substantially equivalent to the predicate device.

VIII. CONCLUSIONS

The subject device is substantially equivalent to its predicate in terms of intended use and indications for use, technological characteristics, manufacturing methods, and principles of operation. The differences in the technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Based on the performance testing and the technological characteristics, it can be concluded that the subject device is substantially equivalent to the predicate 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.