The 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 modified device allows for placement of the implant with 3 lag screws. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Extremity Medical Calcaneal Osteotomy Device.

This document describes a 510(k) premarket notification for a medical device. For such submissions, the acceptance criteria and study data are primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested for "equivalence")	Reported Device Performance
Pull-out strength (mechanical property)	Tested and demonstrated equivalence to the predicate device.
Torque strength (mechanical property)	Tested and demonstrated equivalence to the predicate device.
Bending strength (mechanical property)	Tested and demonstrated equivalence to the predicate device.
Material composition	Equivalent to the predicate device.
Design (bracket, lag screws, instruments)	Equivalent to the predicate device, with a modification allowing 3 lag screws.
Indications for Use	The same as the predicate device: "fixation of osteotomies of the calcaneus."
Principles of Operation	Equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Pull-out, torque and bending strength was assessed compared to the predicate device and worse case constructs have been tested to demonstrate equivalence."

Sample Size: The exact number of samples tested for pull-out, torque, and bending strength is not specified in this document. It mentions "worse case constructs," implying a targeted selection of samples that represent the most challenging scenarios for the device's mechanical integrity.
Data Provenance: The testing appears to be retrospective (or in-vitro testing for regulatory submission) and conducted by the manufacturer, Extremity Medical, LLC. The country of origin for the data is not explicitly stated but can be inferred as the United States, where the company is located and where the submission was made to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence here is based on engineering and mechanical testing standards, not expert clinical consensus or interpretation of patient data. The mechanical tests compare the new device's performance to the known performance of the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. The "adjudication method" primarily applies to human interpretation tasks, such as in clinical trials or diagnostic image readings where multiple experts might disagree. For mechanical testing, the results are typically quantitative and assessed against predefined engineering specifications or direct comparison to predicate device performance.

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

This is not applicable. An MRMC study is relevant to diagnostic or screening devices, often involving AI, to assess the impact on human reader performance. This device is a surgical implant (bone fixation fastener) and does not involve human readers or AI in its direct application or evaluation for this submission.

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

This is not applicable. This device is a physical surgical implant, not an algorithm or an AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is established through:

Mechanical Testing Results: Data from pull-out, torque, and bending strength tests.
Engineering Specifications and Benchmarking: Comparison of the device's performance against the predicate device and relevant industry standards for mechanical properties.
Material Characterization: Verification of the material properties to be equivalent to the predicate device.
Design Review: Comparison of the design features to the predicate device.

8. The Sample Size for the Training Set

This is not applicable. This device does not use an algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, prototyping, and iterative mechanical testing.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8. No "training set" in the AI sense exists for this device. The development process relies on engineering principles and verification against established mechanical and material standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

March 4, 2015

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

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

Re: K150309

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: February 6, 2015 Received: February 9, 2015

Dear Mr. Brian 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 (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/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 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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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)

K150309

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)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Special 510(k) Summary of Safety and Effectiveness:

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	February 6, 2015
Trade Name	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	K143402 - Calcaneal Osteotomy Device (Extremity Medical)
Device Description	The Calcaneal Osteotomy Device is a bone fixation device consisting of abracket and lag screws and a set of instruments used for implant site preparationand delivery. The bracket is offered in height sizes of 6mm to 13mm. Themodified device allows for placement of the implant with 3 lag screws. TheCalcaneal Osteotomy Device is intended for fixation of osteotomies of thecalcaneus.
Indications for use	The Extremity Medical Calcaneal Osteotomy Device is intended for fixation ofosteotomies of the calcaneus.
Statement ofTechnologicalComparison	The Calcaneal Osteotomy Device and predicate devices are equivalent in termsof indications for use, design, and material mechanical properties.
Non-clinical Testing	Pull-out, torque and bending strength was assessed compared to the predicatedevice and worse case constructs have been tested to demonstrate equivalence.
Clinical Testing	No clinical testing was performed.
Conclusion	The Calcaneal Osteotomy Device is substantially equivalent to its predicatedevice. This conclusion is based upon indications for use, materials, design, testdata and principles of operation.

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.