TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

Device Description

The TransLoc 3D System implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint.

AI/ML Overview

The provided document is a 510(k) summary for the TransLoc 3D device, which is a sacroiliac joint fusion implant. The document does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop performance.

Instead, it details the non-clinical testing performed to demonstrate substantial equivalence of the TransLoc 3D device to predicate devices, primarily focusing on mechanical and material properties.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance as it relates to AI/diagnostic studies, human readers, or ground truth establishment in that context. The document only covers the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of "acceptance criteria" in the traditional sense of performance metrics for an AI-driven device (e.g., sensitivity, specificity). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices:

Test Type	Standard/Method	Reported Performance Comment
Dynamic compression-shear	ASTM F2077	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.
Dynamic 3-point bending	ASTM F2193	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.
Static and dynamic cantilever bending	ASTM F2193	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.
Insertion and pullout/pushout testing	ASTM F543	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.
Cadaver implantation and biomechanical studies	Lab protocols	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.
Particulate analysis	USP <788>	Results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.

The document states that "No FDA performance standards have been established for TransLoc 3D." The acceptance criteria are implicitly that the device performs equivalently to the predicate devices in the listed mechanical and material tests.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical, mechanical, and material testing, not a diagnostic or AI performance study with a test set of human data.

3. 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 understood for diagnostic AI (e.g., expert labels on images) is not relevant to the non-clinical tests described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: No, an MRMC study was not done, as this document concerns a medical implant, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the established mechanical properties and material composition as defined by the ASTM standards and USP <788>.

8. The sample size for the training set: Not applicable. There is no AI training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

Summary

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July 27, 2022

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 seal on the left and the FDA acronym and name on the right. The FDA part is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Foundation Fusion Solutions, LLC dba CornerLoc % Mr. Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008

Re: K211496

Trade/Device Name: TransLoc 3D Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 28, 2022 Received: June 29, 2022

Dear Mr. Brittan:

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

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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 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 (OS) 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 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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K211496

Device Name TransLoc 3D

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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510(k) Summary

DATE PREPARED

July 22, 2022

MANUFACTURER AND 510(k) OWNER

Foundation Fusion Solutions, LLC dba CornerLoc 11916 S. Oxford Ave., Suite 206 Tulsa, OK 74137 USA Telephone: (417) 309-9459

REPRESENTATIVE/CONSULTANT

Jeffrey Brittan Vice President of Product Realization Watershed Ideas Foundry Telephone: (714) 287-6780 Email: jeffbrittan@watershedideas.com

PROPRIETARY NAME OF SUBJECT DEVICE

TransLoc 3D

COMMON NAME Sacroiliac joint fixation device

DEVICE CLASSIFICATION

Smooth or threaded metallic bone fixation fastener (Classification Regulations: 21 CFR 888.3040, Product Code: OUR, Class: II)

PREMARKET REVIEW

Orthopedic Panel

INDICATIONS FOR USE

TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

DEVICE DESCRIPTION

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PREDICATE DEVICE IDENTIFICATION

TransLoc 3D is substantially equivalent to the following predicates:

510(k) Number	Predicate Manufacturer & Device Name
K021932	Synthes 6.5mm Cannulated Screw (Primary Predicate)
K180818	Tenon Medical Catamaran Sacroiliac Joint Fixation System(CAT SIJ Fixation System)
K200696	Orthofix FIREBIRD SI Fusion System

The following reference device is also cited in this submission:

. Nvision Biomedical's Trigon Ti Stand-Alone Wedge Fixation System (K192645)

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for TransLoc 3D. Testing was performed, and results demonstrated that TransLoc 3D is substantially equivalent to the predicate devices.

Dynamic compression-shear (ASTM F2077) ●
Dynamic 3-point bending (ASTM F2193)
Static and dynamic cantilever bending (ASTM F2193) ●
. Insertion and pullout/pushout testing (ASTM F543)
Cadaver implantation and biomechanical studies (lab protocols) ●
Particulate analysis (USP <788>) ●

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

CornerLoc believes that TransLoc 3D is substantially equivalent to the identified predicate devices. The subject device has similar design, similar dimensions, and uses similar or identical materials. The subject device has the same indications for use and intended use, as well as similar technological characteristics (threaded and non-threaded titanium implant designs in a range of similar lengths with fixation features that bridge both sides of the SI joint to prevent motion). These technological characteristics have undergone testing/analysis to ensure the subject device is equivalent to the predicates.

CONCLUSION

Based on the testing performed it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed TransLoc 3D are assessed to be 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.