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

Device Description

The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two diameters and lengths ranging from 22mm to 50mm, as well as a mating washer component consisting of one diameter and lengths ranging from 16mm to 35mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are made of surgical grade stainless steel (ASTM F899).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "IntraLock Lapidus System." It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared devices.

Based on the content of the document, the device described is a bone fixation fastener (IntraLock Lapidus System), not an AI/ML-based diagnostic device. Therefore, the questions about acceptance criteria (in terms of AI performance metrics like sensitivity, specificity, AUC), sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance do not apply to this type of medical device submission.

This document describes a traditional medical device, and its acceptance criteria and the study to prove it meets them are related to mechanical properties, biocompatibility, and intended use equivalence to predicate devices, rather than AI performance.

Here's an analysis of the provided information relevant to this type of device:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

The "acceptance criteria" for a traditional Class II device like this are primarily demonstrated through non-clinical testing to show that the device performs as intended and is substantially equivalent to predicate devices in terms of safety and effectiveness.

Acceptance Criteria (Demonstrated via Non-Clinical Testing)	Reported Device Performance / Evaluation
Mechanical Performance and Safety:
Static torsion analysis meets criteria	Conducted. Results: Indicate equivalence to predicate devices.
Insertion torque analysis meets criteria	Conducted. Results: Indicate equivalence to predicate devices.
Pull-out analysis meets criteria	Conducted. Results: Indicate equivalence to predicate devices.
Static 4-point bending test meets criteria	Conducted. Results: Indicate equivalence to predicate devices.
Dynamic 4-point bending test meets criteria	Conducted. Results: Indicate equivalence to predicate devices.
Material Biocompatibility:
Pyrogenicity (endotoxin levels) meets criteria	Evaluated using Limulus amebocyte lysate (LAL) assay. Demonstrated to meet recommended maximum endotoxin level of 20 EU per device.
Design and Material Equivalence:
Comparable design principles	The device is described as a two-part construct (lag screw and mating washer) made of titanium alloy (TI6Al4V), which is similar in concept and materials to existing bone fixation fasteners.
Comparable materials used (Ti-6Al-4V allele, Stainless steel)	Confirmed.
Intended Use Equivalence:
Indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of small bones and joints in the foot. Specifically for Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.	This aligns with the indications for existing predicate devices.

Study Proving Device Meets Acceptance Criteria:

Sample sizes used for the test set and the data provenance:
- For mechanical testing, the "sample size" refers to the number of test specimens (e.g., screws, washers) subjected to the specified tests. The document does not specify the exact number of samples for each mechanical test (e.g., how many screws were pulled out, how many were bent). The provenance is laboratory testing conducted by the manufacturer, Fusion Orthopedics, LLC.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device classification does not involve medical image interpretation or clinical ground truth establishment in the way AI/ML devices do. The "ground truth" for this device's performance is established by standardized engineering and biocompatibility testing methods against predefined specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication is involved in the mechanical or biocompatibility testing of a bone fixation device for a 510(k) submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. MRMC studies are specific to diagnostic devices (especially imaging-based ones) where human reader performance is a critical outcome. This is a surgical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on engineering standards and specifications (e.g., acceptable loads, torques, displacement) and biocompatibility standards (e.g., endotoxin limits). It's not based on clinical "ground truth" like pathology or expert consensus on a diagnosis.
The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. There is no training set.

In summary, the provided document describes a traditional orthopedic implant device undergoing a 510(k) premarket notification. The "acceptance criteria" and "proof" are based on non-clinical laboratory testing to demonstrate mechanical integrity, material compatibility, and substantial equivalence to existing predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.

Summary

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Image /page/0/Picture/0 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 along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

May 21, 2019

Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212

Re: K182342

Trade/Device Name: IntraLock Lapidus System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 19, 2019 Received: April 22, 2019

Dear Eli Jacobson:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative 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) K182342

Device Name IntraLock Lapidus System

Indications for Use (Describe)

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

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 Prepared	April 16, 2019
Submitted By	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876
Primary Contact	Eli Jacobson4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-6876 Telee-mail: eli@fusionorthopedics.com
Trade Name	IntraLock Lapidus System
Common Name	Bone Screws
Classification Name	Smooth & threaded metallic bone fixation fasteners
Class	II
Product Code	HWC
CFR Section	21 CFR section 888.3040
Device Panel	Orthopedic
Primary PredicateDevice	EXTREMITY MEDICAL Screw and Washer Implant System, Extremity Medical (K10700)
Secondary PredicateDevice	FuzeFix Screw System, Fusion Orthopedics (K170038)
Device Description	The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of twodiameters and lengths ranging from 22mm to 50mm, as well as a mating washercomponent consisting of one diameter and lengths ranging from 16mm to 35mm. TheIntraLock Implants are constructed of titanium alloy (TI6AI4V). The specializedinstruments are made of surgical grade stainless steel (ASTM F899).
Indications for Use	The IntraLock Lapidus System is indicated for reduction and internal fixation ofarthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the smallbones and joints in the foot. The two-part construct is specifically intended for use inTalonavicular, 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 Lapidus System is substantially equivalent to the predicate devices interms of intended use, design, materials used, mechanical safety and performances.
Non-clinical TestSummary	The following analyses were conducted:-Static torsion analysis.-Insertion torque analysis.-Pull-out analysis.The following tests were conducted:- Static 4-point bending test.- Dynamic 4-point bending test.- Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. Thetesting demonstrated that the subject device meets the recommended maximumendotoxin level of 20 EU per device.The results of these evaluations indicate that the IntraLock Lapidus System is equivalentto predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions:	Fusion Orthopedics LLC considers the IntraLock Lapidus System to be equivalent to thepredicate devices 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.