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, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.

Device Description

The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.

AI/ML Overview

The provided document describes a medical device, specifically the EXTREMITY MEDICAL Screw and Washer System, not an AI/ML-driven medical device. Therefore, many of the requested categories related to algorithms, AI performance, ground truth, and expert evaluation are not applicable.

However, I can extract the information pertinent to the acceptance criteria and the study performed for this device based on the document.

Acceptance Criteria and Device Performance for EXTREMITY MEDICAL Screw and Washer System

Given that this is a 510(k) submission for a traditional medical device (screws and washers), the acceptance criteria are generally based on demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical performance.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from "Statement of Technological Comparison" and "Non-clinical Testing")	Reported Device Performance
Indications for Use	Same as predicate device (EXTREMITY MEDICAL Screw and Washer System, K101700)	Met (Explicitly stated)
Design	Similar to predicate device	Met (Explicitly stated)
Materials	Similar to predicate device	Met (Explicitly stated)
Mechanical Properties	Equivalent mechanical properties to predicate device	Met (Demonstrated via bench testing)
Surgical Technique	Verification of surgical technique with new screw and washer options	Met (Verified via clinical simulations in cadavers)
Biocompatibility	(Inferred - standard for implantable devices, assumed to be covered by material similarity to predicate)	(Not explicitly detailed in summary, but assumed favorable as similar to predicate)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The "test set" here refers to the samples used in bench testing and cadaver studies.
- Bench Testing: The document states "pull-out, torque and bending was performed." The specific number of screws/washers tested for each modality is not specified.
- Cadaver Studies: "Clinical simulations in cadavers were performed." The number of cadavers or specific procedures performed is not specified.
Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data originated from in-vitro (bench testing) and ex-vivo (cadaver) studies conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is a mechanical device, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" for mechanical properties is established by engineering standards and measurements, and for surgical technique, by observed performance by qualified personnel (surgeons/engineers) during cadaveric trials. The specific number and qualifications of these personnel are not specified but would typically include bioengineers and orthopedic surgeons.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers for AI/ML ground truth. For this device, the "adjudication" would involve engineering analysis of the bench test data and expert assessment of the cadaveric simulations.

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/ML diagnostic or prognostic tools, not for a mechanical bone fixation system.

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

No, a standalone algorithm performance study was not done. This is a hardware medical device, not an algorithm.

7. The type of ground truth used

Not applicable in the AI/ML sense. For this device:
- Mechanical performance: Ground truth is based on established engineering standards and measurements (e.g., specific force required for pull-out, torque values, bending resistance).
- Surgical technique: Ground truth is based on successful and stable fixation demonstrated in cadaveric models as assessed by trained professionals.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the AI/ML context.

9. How the ground truth for the training set was established

Not applicable. This device does not use a "training set" or require ground truth establishment in the AI/ML context.

Summary of the Study:

The study conducted to demonstrate the safety and effectiveness of the EXTREMITY MEDICAL Screw and Washer System was a non-clinical study. It consisted of:

Bench testing: This involved mechanical testing such as pull-out, torque, and bending tests. The results of these tests were compared to the predicate devices to demonstrate equivalent mechanical properties.
Clinical simulations in cadavers: These studies were performed to verify the surgical technique with the additional screw and washer options being introduced.

The conclusion drawn from these studies was that the device is substantially equivalent to its predicate device based on indications for use, materials, design, test data, and principles of operation. No clinical testing in live subjects was performed.

Summary

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JUL 1882012

Special 510(k) Summary of Safety and Effectiveness:

EXTREMITY MEDICAL Screw and Washer System

Submitter:	EXTREMITY MEDICAL LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Jamy GannoePresidentPhone: (973) 588-8980Email: jgannoe@extremitymedical.com
Date Prepared	June 11, 2012
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	EXTREMITY MEDICAL Screw and Washer System, Extremity Medical (K101700)
Reason for Submission	Additional screw and washer options have been added to the system to allow forintraoperative flexibility for the surgeon.
Device Description	The EXTREMITY MEDICAL Screw and Washer System consists of twopieces, a Screw and a Washer, which couple together to provide stability andcompression across an intended area of fusion.
Indications for use	"The Extremity Medical Screw and Washer System is intended for reduction andinternal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures andnonunions of the small bones and joints of the foot, ankle, hand, and wrist. Thetwo-part construct is specifically intended for Talonavicular, Calcaneocuboid,Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis,as well as Metatarsal Osteotomies."
Statement ofTechnologicalComparison	The EXTREMITY MEDICAL Screw and Washer System and its predicatedevices have the same indications for use; have a similar design; are made ofsimilar materials, and have equivalent mechanical properties.
Non-clinical Testing	Bench testing, including pull-out, torque and bending was performed andcompared to the predicate devices. Clinical simulations in cadavers wereperformed to verify the surgical technique.
Clinical Testing	No clinical testing was performed.
Conclusion	The EXTREMITY MEDICAL Screw and Washer System is substantiallyequivalent to its predicate devices. This conclusion is based upon indications foruse, materials, design, test data and principles of operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Extremity Medical, LLC % Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

JUL 18 2012

Re: K121349

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 Product Code: HWC Dated: June 15, 2012 Received: June 18, 2012

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, 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

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Page 2 - Jamy Gannoe

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 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/CDRH/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 vours.

Eunel Keith

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

Enclosure

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EXTREMITY MEDICAL Screw System

. .

Special 510(k) Premarket Notification

Indications for Use

510(k) Number (if known):	K121349
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 extraricular 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 Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.

Over-the-counter Prescription Use X AND/OR (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 K121349

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.