The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
- Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)
Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here.
Adjudication method for the test set: Not applicable.
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, this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.
The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.
The sample size for the training set: Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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

February 4, 2015

Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K143402

Trade/Device Name: Extremity Medical Calcaneal Osteotomy Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: November 25, 2014 Received: November 28, 2014

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

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Page 2 - Mr. Brian Smekal

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/Resourcesfor You/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 vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143402 (paqe 1/1)

Device Name

Extremity Medical Calcaneal Osteotomy Device

Indications for Use (Describe)

The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Extremity Medical Calcaneal Osteotomy Device

Submitter:	Extremity Medical, LLC.300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Brian Smekal, MS, RACDirector, Regulatory AffairsPhone: (973) 588-8988Email: bsmekal@extremitymedical.com
Date Prepared	November 25, 2014
Trade Name	Extremity Medical Calcaneal Osteotomy Device
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040
Product Code	HWC (screw, fixation, bone), HRS (plate, fixation, bone)
Predicate Devices	K121349 - Extremity Medical Screw and Washer System (IO FiX)K052614 - Arthrex Low Profile Plate and Screw System (CalcaneusStepPlate)K124022 - Speed Shift (Biomedical Enterprises)
Device Description	The Extremity Medical Calcaneal Osteotomy Device is a bone fixation deviceconsisting of a bracket and lag screws and a set of instruments used for implantsite preparation and delivery. The bracket is offered in height sizes of 6mm to13mm. The Calcaneal Osteotomy Device is intended for fixation ofosteotomies of the calcaneus.
Indications for use	The Extremity Medical Calcaneal Osteotomy Device is intended for fixation ofosteotomies of the calcaneus.
Statement ofTechnologicalComparison	The Extremity Medical Calcaneal Osteotomy Device and predicate devices areequivalent in terms of indications for use, design, and material mechanicalproperties.
Non-clinical Testing	Bench testing static and dynamic bending were performed and compared to thepredicate device.
Clinical Testing	No clinical testing was performed.
Conclusion	The Extremity Medical Calcaneal Osteotomy Device is substantiallyequivalent to its predicate device. This conclusion is based upon indicationsfor use, principles of operation, design, and mechanical test data.

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.