The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

Device Description

The EXTREMITY MEDICAL Compression Screw

AI/ML Overview

This 510(k) Premarket Notification for the EXTREMITY MEDICAL Compression Screw does not contain information about acceptance criteria or a study proving the device meets them.

The provided document is a summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against predefined acceptance criteria. This type of submission relies on the fact that similar, legally marketed devices (predicates) have already met regulatory requirements.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details based on the information given.

Here's a breakdown of why and what information is missing:

Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds) or report specific performance metrics of the EXTREMITY MEDICAL Compression Screw against such criteria. The "Statement of Technological Comparison" only broadly states similarity in design and materials to predicate devices.
Sample Sized used for the test set and the data provenance: Not applicable, as no performance study data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study data is presented.
Adjudication method for the test set: Not applicable, as no performance study data is presented.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a medical implant, not an imaging or diagnostic AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a medical implant, not an AI algorithm.
The type of ground truth used: Not applicable, as no performance study data is presented.
The sample size for the training set: Not applicable, as no AI/algorithm training set is involved.
How the ground truth for the training set was established: Not applicable, as no AI/algorithm training set is involved.

Conclusion from the document:

The conclusion states: "The EXTREMITY MEDICAL Compression Screw is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation."

This indicates that the regulatory pathway chosen here (510(k)) relies on demonstrating similarity to existing, legally marketed devices, rather than comprehensive de novo performance testing against specific acceptance criteria.

Summary

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K081934

510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness:

AUG 2 9 2008

EXTREMITY MEDICAL Implant System

Submitter:	EXTREMITY MEDICAL LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Jamy GannoePresidentPhone: 973-316-9900Email: jgannoe@extremitymedical.com
Date Prepared	August 15, 2008
Trade Name	EXTREMITY MEDICAL Compression Screw
Classification Nameand Number	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040
Product Code	HWC
Predicate Devices	1. Synthes, Compression Screw K0506362. Newdeal, I.CO.S K9937623. Kinetikos Medical, Inc., Kompressor K024233
Device Description	The EXTREMITY MEDICAL Compression Screw
Indications for use	The Extremity Medical Compression Screw is intended forreduction and internal fixation of arthrodeses, osteotomies,intra- and extra-articular fractures and nonunions of the smallbones and joints of the foot and hand. Examples includescaphoid fractures, tarsal and metatarsal fracture, hand, wrist,foot and ankle arthrodeses, metacarpal and metatarsalarthrodeses, distal radius fractures.
Statement ofTechnologicalComparison	The EXTREMITY MEDICAL Compression Screw and itspredicate devices have the same indications for use have asimilar design and are made of the similar materials.
Conclusion	The EXTREMITY MEDICAL Compression Screw issubstantially equivalent to its predicate devices. Thisconclusion is based upon the fact that this device is substantiallyequivalent in terms of indications for use, materials, design andprinciples of operation.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. In the center of the seal is a stylized image of an abstract human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2008

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

Re: K081934

Trade/Device Name: EXTREMITY MEDICAL Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 2, 2008 Received: July 7, 2008

Dear Mr. 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 (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.

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); 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.

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Page 2 -- Mr. Jamy Gannoe

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhusan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

Screw

Indications for Use

510(k) Number (if known):
Device Name:	EXTREMITY MEDICAL Compression
Indications for Use:

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)

Mark M. Mikkelsen

and I

510(k) Number

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.