The IntraLock System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

Device Description

The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made of surgical grade stainless steel (per ASTM F899) with certain components made from aluminum alloy (Al6061).

AI/ML Overview

This FDA 510(k) summary describes a medical device, the IntraLock System, but does not include information about a study based on AI or software performance. Instead, it focuses on the device's substantial equivalence to predicate devices through non-clinical mechanical testing.

Therefore, I cannot provide an answer that includes acceptance criteria and study details related to AI or software performance, as this information is not present in the provided document.

Here's an analysis of what is available in the document, framed by your questions where applicable, and noting where the requested information is absent:

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

Acceptance Criteria: The document implies that the acceptance criteria are met if the IntraLock System's mechanical performance is "equivalent to that of the predicate." However, specific numerical acceptance criteria (e.g., in terms of load capacity, fatigue cycles, or specific failure modes) are not provided.
Reported Device Performance: Similarly, specific numerical reported performance data from the non-clinical tests are not provided. The document only states that "Both Static and Dynamic mechanical testing is presented to provided evidence that the IntraLock System is equivalent to that of the predicate."

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

This question is not applicable as the study described is non-clinical mechanical testing of a physical device, not an AI or software performance study using a test set of data. The document does not specify the number of samples used for the static and dynamic mechanical tests.

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)

This question is not applicable. Ground truth, in the context of AI/software performance, refers to expert-validated labels or outcomes. The described study is mechanical testing of a device where "ground truth" would be the measured physical properties or failure points, not expert interpretation of data.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or AI/software validation studies to resolve discrepancies in expert labeling or diagnoses.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation system's mechanical performance.

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

No, a standalone algorithm performance study was not done. This device is a physical bone fixation system, not an algorithm.

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

This question is not directly applicable in the context of mechanical testing. The "ground truth" for the non-clinical mechanical tests would be the established engineering standards, material properties, and physical measurements (e.g., force applied, displacement, cycles to failure) observed during the testing, compared against the predicate device.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not an AI model, and therefore does not have a "training set."

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

This question is not applicable for the same reasons as #8.

Summary

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July 23, 2021

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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fusion Orthopedics, LLC Whitney Rey Official Correspondent 4135 S. Powder Rd., Suite 110 Mesa. Arizona 85212

Re: K210159

Trade/Device Name: IntraLock System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 23, 2021 Received: June 24, 2021

Dear Whitney Rey:

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

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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,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K210159

Device Name IntraLock System™

Indications for Use (Describe)

IntraLock is indicated for reduction and internal fixation of arthrodesis, osteotomies, intra-and extra-articular fractures, and nonunions of the small bones and joints of the three-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform Arthrodesis.

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)

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510(k) Summary: IntraLock System

Date Prepared	06/23/2021
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Primary Contact	Whitney Rey4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: whitney@fusionorthopedics.com
Trade Name	IntraLock System
Common Name	Screw, Fixation, Bone
Classification Name	Smooth & threaded metallic bone fixation fasteners
Class	II
Product Code	HWC
CFR Section	21 CFR section 888.3040
Common Name	Screw, Fixation, Bone
Device Panel	Orthopedic
Primary PredicateDevice	Fusion Orthopedics' IntraLock Lapidus System (K182342)
Secondary PredicateDevice	Fusion Orthopedics' FuzeFix Screw System (K170038)
Device Description	The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter withlengths ranging from 14mm to 24 mm, as well as a mating washer component consistingof 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants areconstructed of titanium alloy (TI6AI4V). The specialized instruments are primarily madeof surgical grade stainless steel (per ASTM F899) with certain components made fromaluminum alloy (Al6061).
Indications for Use	The IntraLock System is indicated for reduction and internal fixation of arthrodeses,osteotomies, intra- and extra-articular fractures, and nonunions of the small bones andjoints of the foot. The two-part construct is specifically intended for use in Talonavicular,Calcaneocuboid, and Metatarsocuneiform arthrodesis.
Materials	Ti-6Al-4V alloy (ASTM F136)Stainless steel (ASTM F899)6061 Aluminum (ASTM B209)
SubstantialEquivalence Claimedto Predicate Devices	The Intralock System and the predicate system are manufactured from the samematerial and process, with similar sized screws and are substantially equivalent in termsof intended use, design, mechanical safety and performance.
Non-clinical TestSummary	Both Static and Dynamic mechanical testing is presented to provided evidence that theIntraLock System is equivalent to that of the predicate.
	The sterilization, cleaning, packaging, material, and manufacturing methods are identicalto that of the predicate.
Clinical TestSummary	No clinical studies were performed.
Conclusions:	Fusion Orthopedics LLC considers the IntraLock System to be equivalent to thepredicate device listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use.

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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.