The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.

Device Description

The AXI+LINE™ Proximal Bunion Correction System is a plate system made from Titanium alloy. The geometry of the plate is that of a modified semi-tubular bone plate with a correction angle between the proximal and distal plate segments. The system also includes non-locking cortical and locking screws also made from Titanium alloy and necessary surgical site preparation and insertion instruments as a procedure pack.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "AXI+LINE™ Proximal Bunion Correction System."

The information provided does not describe an AI/ML-based device or a study involving human readers or algorithmic performance metrics typical for AI/ML validation. Instead, it describes a traditional orthopedic implant device.

Therefore, I cannot extract the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The "Safety and Performance" section of the 510(k) Summary (page 4) details the mechanical testing performed for this physical device, which involves:

Finite Element Analysis (FEA): Used to determine the worst-case plate configuration for static and dynamic four-point bend testing.
Mechanical Testing: Performed according to recognized standards:
- ASTM F-382: Static and dynamic 4-point bend testing of the AXI+LINE™ Proximal Bunion Correction System plate.
- ASTM F-543: Axial push-out, insertion torque, and torque to failure testing of the locking and non-locking bone screws.
Biocompatibility: Not performed, as the device is made from standard medical Titanium alloy (ASTM F136), which has a long history of successful use in similar orthopedic indications and is the same material as a predicate device (Nextremity MSP Metatarsal Shortening System).

The acceptance criteria for such a device would typically be that the device meets or exceeds the mechanical performance requirements defined in the referenced ASTM standards (F-382 and F-543), demonstrating equivalence to predicate devices and being safe and effective for its indicated use. The document states that the testing demonstrated the device to be "substantially equivalent to predicate devices" based on indications for use, technological characteristics, and performance testing.

In summary, the provided document is for a physical medical implant, not an AI/ML software device. The questions relate to AI/ML validation, which is out of scope for this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2015

Nextremity Solutions, Incorporated Mr. Rvan Schlotterback Director, Product Development 210 North Buffalo Street Warsaw, Indiana 46580

Re: K152548 Trade/Device Name: AXI+LINE™ Proximal Bunion Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 20, 2015 Received: November 23, 2015

Dear Mr. Schlotterback:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K152548

Device Name: AXI+LINE™ Proximal Bunion Correction System

Indications for Use:

The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

(Prepared on September 1, 2015)

Pursuant to §513(i) (3) (A) of the Food, Drug, and Cosmetic Act, Nextremity Solutions, Inc. is submitting the following summary of information:

Trade Name:	AXI+LINE™ Proximal Bunion Correction System
Sponsor:	Nextremity Solutions, Inc.210 North Buffalo StreetWarsaw, IN 46580
Contact Person:	Ryan SchlotterbackDirector, Product Development210 North Buffalo StreetWarsaw, IN 46580Direct: 574.485.2867Mobile: 574.265.5308Fax: 574.966.1396
Device ClassificationName:	Single/multiple Component Metallic BoneFixation Fastener Appliances and Accessories21 CRF §888.3030Product Code: HRSSmooth or Threaded Metallic Bone FixationFastener and Accessories21 CFR §888.3040Product Code: HWC
Classification:	According to Section 13 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards.
Predicate Devices:	K131061 – Nextremity Solutions – Restore™ BunionCorrection SystemK140724 – Nextremity Solutions – MSP™ MetatarsalShortening SystemK143365 - Empirical Testing Corp.- Eminent Foot PlateSystemK142581 - PaxMed International LLC – APTUS FootSystem
	The Nextremity Solutions AXI+LINE™ Proximal BunionCorrection System possesses the same technologicalcharacteristics as the predicate devices. These characteristicsinclude the intended use, basic design, material, size andfundamental technology.
Device Description:	The AXI+LINE™ Proximal Bunion Correction System is aplate system made from Titanium alloy. The geometry ofthe plate is that of a modified semi-tubular bone plate with acorrection angle between the proximal and distal platesegments. The system also includes non-locking corticaland locking screws also made from Titanium alloy andnecessary surgical site preparation and insertion instrumentsas a procedure pack.
Indications for Use:	The Nextremity Solutions AXI+LINE™ Proximal BunionCorrection System is indicated for fixation of fractures,osteotomies, non-unions and fusions of small bones andsmall bone segments in the foot and ankle.
Safety and Performance:	Finite Element Analysis was used to determine the worst-case plate configuration for the static and dynamic four-point bend testing.
	Mechanical testing was performed as described in relevantrecognized standards, including static and dynamic 4 pointbend testing of the AXI+LINE™ Proximal BunionCorrection System plate per ASTM F-382 and axial push-out, insertion torque, and torque to failure testing of thelocking and non-locking bone screws per ASTM F-543.
	The product is made from the same material as the predicateNextremity MSP Metatarsal Shortening System. The devicecomponents are comprised of standard medical Titaniumalloy (ASTM F136) with a long history of successful use forthe same and other orthopedic indications. Biocompatibilitytesting was, therefore, not performed in support of theproposed device.
Conclusion:	Based on comparisons of the indications for use,technological characteristics, and the results of performancetesting described above, the AXI+LINE™ Proximal BunionCorrection System has been shown to be substantially

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equivalent to predicate devices used for the same clinical indications.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.