The Siloin®T3 is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis. Two SiJoin® T3 implants must be used in the same sacroiliac joint.

Device Description

The VGI Medical, LLC Siloin®T3 Implant consists of a series of titanium alloy (per ASTM F3001) implants that are designed to provide mechanical support by transfixing the sacroiliac joint while biologic fusion occurs. The device consists of the implant body and perpendicular fins to provide stability while fusion occurs. The devices are available in five sizes to accommodate varied patient's anatomy.

AI/ML Overview

This document describes the 510(k) premarket notification for the SiJoin®T3 implant. It does not contain information about an AI/ML medical device, and therefore does not have the details required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance.

The provided text pertains to a medical implant (SiJoin®T3) intended for sacroiliac joint fusion. The performance testing described is biomechanical in nature (Static Vertical Shear, Dynamic Vertical Shear, Axial Pushout, and a cadaver range of motion study), not related to AI/ML algorithm performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving AI/ML device performance based on the provided text. The document does not contain any of the requested information regarding:

A table of acceptance criteria and reported device performance for an AI/ML algorithm.
Sample size used for an AI/ML test set or data provenance.
Number of experts for AI/ML ground truth, or their qualifications.
Adjudication method for an AI/ML test set.
Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
Standalone performance for an AI algorithm.
Type of ground truth used for an AI/ML algorithm (e.g., pathology, outcomes data).
Sample size for an AI/ML training set.
How ground truth for an AI/ML training set was established.

Summary

{0}------------------------------------------------

March 29, 2023

Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which 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.

VGI Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905

Re: K213815

Trade/Device Name: SiJoin®T3 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: February 22, 2023 Received: February 23, 2023

Dear Richard Jansen:

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. 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 located 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213815

Device Name SiJoin®T3

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Date Prepared:	March 28, 2023
Contact:	VGI Medical, LLC11651 87th StreetLargo, FL 33773Telephone: 727-565-1235Fax: 727-388-0227
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com
Trade Name:	SiJoin®T3 Implant
Product Class:	Class II
Classification:	21 CFR §888.3040
Common Name:	Smooth or threaded metallic bone fixation fastener
Product Codes:	OUR
Panel Code:	87

Indications for Use:

The SiJoin®T3 is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Two SiJoin® T3 implants must be used in the same sacroiliac joint.

Device Description:

Predicate Device(s):

The VGI Medical, LLC Siloin®T3 Implant is substantially equivalent to the Primary Predicate device, which is the Tenon Medical, Inc. Catamaran Sacroiliac Joint Fixation System (K180818).

Performance Testing Summary:

There are no ASTM or ISO standards for SI fixation currently available, so a battery of tests was designed to test clinical and biomechanical relevancy. Four biomechanical tests were completed. These were:

1. Static Vertical Shear
1. Dynamic Vertical Shear
1. Axial Pushout
1. Side-by-side cadaver range of motion study compared to a predicate device

{4}------------------------------------------------

Technological Characteristics:

VGI Medical, LLC. has compared the SiJoin®T3 Implant to the predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.

Conclusion:

VGI Medical, LLC. concludes that these SiJoin®T3 Implant devices are substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.

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.