The Align Anterior Ankle Fusion Plate is a bone fixation device consisting of an anatomical, anterior tibia plate and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plate is available in three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Align Anterior Ankle Fusion Plate." This document primarily deals with establishing substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria through a study with human data. Therefore, it does not contain the information required to answer the questions about acceptance criteria, a test set, ground truth establishment, or clinical study specifics like MRMC studies or human reader improvement.

Specifically:

No acceptance criteria table or device performance: The document does not specify quantitative acceptance criteria for device performance based on human data or medical imaging, nor does it report such performance. The reported "performance" is in terms of mechanical strength demonstrated via bench testing.
No sample size for test set or data provenance: No clinical test set data is described. The "testing" mentioned is bench testing.
No experts for ground truth: Since no clinical data or imaging interpretation is discussed, there is no mention of experts or ground truth establishment.
No adjudication method: Not applicable as there's no clinical test set requiring adjudication.
No MRMC comparative effectiveness study: The document explicitly states "No clinical testing was performed."
No standalone (algorithm only) performance: This device is a physical medical implant, not an algorithm.
No ground truth type: Not applicable as no clinical data or clinical interpretation is being evaluated.
No sample size for training set: Not applicable as no AI/ML model or training set is involved.
No ground truth for training set established: Not applicable.

The document focuses on:

Device Description: The Align Anterior Ankle Fusion Plate is a bone fixation device for ankle arthrodesis.
Predicate Devices: It lists several predicate devices (e.g., Extremity Medical Compression Screw, Extremilock Ankle Plating System).
Technological Comparison: States that the subject device and predicate devices are equivalent in terms of indications for use, design, and material mechanical properties.
Non-clinical Testing: Mentions "Bench testing including pull-out, torque on the screws and engineering analysis was used to demonstrate that the mechanical strength of the subject device was substantially equivalent to the predicate device."
Clinical Testing: Explicitly states, "No clinical testing was performed."
Conclusion: The device is "substantially equivalent" to its predicate device based on indications for use, principles of operation, design, and mechanical test data.

In summary, this document is a regulatory filing for a medical implant, demonstrating equivalence based on design and mechanical bench testing, not a study evaluating clinical performance, especially not one involving AI/ML or human readers interpreting medical images. Therefore, the information requested in the prompt is not present in the provided text.

Summary

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

March 25, 2016

Extremity Medical, LLC Mr. Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K160191 Trade/Device Name: Align Anterior Ankle Fusion Plate 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: January 26, 2016 Received: January 27, 2016

Dear Mr. Smekal:

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

510(k) Number (if known) K160191

Device Name Align Anterior Ankle Fusion Plate

Indications for Use (Describe)

The Align Anterior Ankle Fusion Plate is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary of Safety and Effectiveness: Align Anterior Ankle Fusion Plate

Submitter	Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054
ContactPerson	Brian Smekal, MS, RACVP, Regulatory Affairs and Quality AssurancePhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	March 21, 2016
Trade Name	Align Anterior Ankle Fusion Plate
ClassificationName andNumber	21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories; 21CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Product Code	HRS (plate, fixation, bone); HWC (screw, fixation, bone)
PredicateDevices	K081934 - Extremity Medical Compression ScrewK133691 – Extremilock Ankle Plating SystemK132591 - Maxlock Extreme SystemK121425 - Ortholoc 3Di Ankle Fusion Plating System and Ortholoc Bone Screws
DeviceDescription	The Align Anterior Ankle Fusion Plate is a bone fixation device consisting of an anatomical, anteriortibia plate and various locking and non-locking screws and a set of instruments used for implant sitepreparation and delivery. The plate is available in three configurations, a slim plate and a 2-tab plate(available in two widths). A central hole in the plate allows for angled placement of a "home run"screw to obtain axial compression across the tibiotalarcalcaneal) (TTC) joints.The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT andvisualization of fusion under fluoroscopy.
Indications foruse	The Align Anterior Ankle Fusion Plate is intended to facilitate arthrodesis of the ankle includingtibiotalocalcaneal and tibiotalar joints.
Statement ofTechnologicalComparison	The Align Anterior Ankle Fusion Plate and predicate devices are equivalent in terms of indicationsfor use, design, and material mechanical properties.
Non-clinicalTesting	Bench testing including pull-out, torque on the screws and engineering analysis was used todemonstrate that the mechanical strength of the subject device was substantially equivalent to thepredicate device.
ClinicalTesting	No clinical testing was performed.
Conclusion	The Align Anterior Ankle Fusion Plate is substantially equivalent to its predicate device. Thisconclusion is based upon indications for use, principles of operation, design, and mechanical testdata.

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.