The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.

Device Description

The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.

AI/ML Overview

The EXTREMITY MEDICAL Screw and Washer System is a medical device intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The device received 510(k) clearance (K101700) from the FDA on October 12, 2010.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Properties	Similar design, materials, and equivalent mechanical properties to predicate devices. Pull-out strength, torque, and bending performance at least as good as predicate devices.	"Mechanical Testing and calculations have been completed supporting substantial equivalence to the predicate devices listed. The implants in the EXTREMITY MEDICAL Screw and Washer system have a similar design; are made of similar materials, have the same indications for use, and have equivalent mechanical properties. Bench testing, including pull-out strength, torque, and bending, was performed and compared to the predicate devices. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices."
Clinical Simulation	Verification of surgical technique in cadavers.	"Clinical simulations in cadavers were performed to verify the surgical technique. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices."
Safety and Effectiveness	Constitutes a safe and effective medical device, meeting all declared requirements of its intended use, with no adverse health effects or safety risks.	"The EXTREMITY MEDICAL Screw and Washer System, subject of this submission, as supported by both mechanical testing and clinical simulation, constitutes a safe and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended."
Substantial Equivalence	Demonstrates substantial equivalence to predicate devices.	"The EXTREMITY MEDICAL Screw and Washer System performed as well as the predicate devices." (Conclusion); "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." (FDA Letter)

Study Proving Acceptance Criteria:

The device's acceptance criteria were primarily met through non-clinical bench testing and clinical simulations in cadavers, demonstrating substantial equivalence to predicate devices.

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

Test Set Sample Size: The document does not explicitly state the numerical sample size for the bench testing (e.g., number of screws/washers tested for pull-out strength, torque, bending). For clinical simulations, it mentions "cadavers," implying a biological sample, but the specific number is not provided.
Data Provenance: The data provenance is retrospective, as it involves testing performed on the device and comparator devices rather than on human patients in a prospective clinical trial. The country of origin of the data is not explicitly stated but is implied to be within the scope of the submitting company's operations, likely the USA given the FDA submission.

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

This information is not provided in the given document. The study primarily relies on objective mechanical testing and cadaveric simulations, not expert interpretation of results to establish ground truth in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" typically refers to how disagreements are resolved among multiple human reviewers when establishing a ground truth, often in the context of diagnostic studies. The studies performed here (mechanical bench testing, cadaveric simulations) do not involve such a process.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human performance is compared with and without AI assistance. This device is a surgical implant system, not a diagnostic AI.

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

No, a standalone algorithm-only performance study was not done. This device is a physical implant; it does not have an "algorithm-only" mode. The device's performance is inherently linked to its physical properties and how it's used in a surgical context by a human.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

Bench Test Standards: Mechanical properties (pull-out strength, torque, bending) were measured against established engineering standards or direct comparison to the performance of legally marketed predicate devices. The "truth" is that the new device's performance met or exceeded the predicate device's performance.
Cadaveric Verification: The "truth" in clinical simulation was the successful verification of the surgical technique in cadavers, confirming the device's usability and appropriate mechanical behavior within a biological model.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical implant, not an AI/ML algorithm, and therefore does not have a training set.

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

This information is not applicable. As explained above, there is no training set for this type of medical device.

Summary

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K101700
PG. 1/1

510(k) Summary of Safety and Effectiveness:

EXTREMITY MEDICAL Screw and Washer Implant System

Submitter:	EXTREMITY MEDICAL300 Interpace ParkwaySuite 410Parsippany, NJ 07054
	OCT 12 2010
Contact Person	Jamy GannoePresidentPhone: (973) 588-8980Email: jgannoe@extremitymedical.com
Date Prepared	September 15, 2010
Trade Name	EXTREMITY MEDICAL Screw and Washer System
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040
Product Code	HWC
Predicate Devices	1. EXTREMITY MEDICAL Compression Screw System, EXTREMITYMEDICAL K0819342. 3.0 Cannulated Screw and Threaded Washer , Synthes K9628233. EXTREMITY MEDICAL Midfoot Screw System, EXTREMITYMEDICAL K082934
Device Description	The EXTREMITY MEDICAL Screw and Washer System consists of a lag screw of five various diameters and lengths ranging from 10 to 100mm, as well as a mating washer component consisting of five various diameters and lengths ranging from 14 to 50mm. Both implant components are manufactured from Titanium alloy.
Indications for use	The EXTREMITY MEDICAL Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.
Statement ofTechnologicalComparison	Mechanical Testing and calculations have been completed supporting substantial equivalence to the predicate devices listed. The implants in the EXTREMITY MEDICAL Screw and Washer system have a similar design; are made of similar materials, have the same indications for use, and have equivalent mechanical properties.
Non-clinical Testing	Bench testing, including pull-out strength, torque, and bending, was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique. The results of the testing show the subject device, Extremity Medical Screw and Washer system, performed at least as well as the predicate devices.
Clinical Testing	No clinical testing was performed.
Conclusion	The EXTREMITY MEDICAL Screw and Washer System, subject of this submission, as supported by both mechanical testing and clinical simulation, constitutes a safe and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended. The EXTREMITY MEDICAL Screw and Washer System performed as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers inside of a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.

:44:

Public Health Service

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

EXTREMITY MEDICAL % Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

DET 2 2010

Re: K101700

Trade/Device Name: EXTREMITY MEDICAL Screw and Washer System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II ್ಕ್ Product Code: HWC Dated: August 31, 2010 57

Received: September 16, 2010

Dear Jamy Gannoe:

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. Iisting 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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Page 2 - Jamy Gannoe

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours

Oth. in
Del Dly

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

1101700 510(k) Number (if known): Device Name: EXTREMITY MEDICAL Screw and Washer System Indications for Use:

The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcanealcuboid, Metatarso-Cunieform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotemies.

Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101700

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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.