The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.

Device Description

The S-Wire is composed of wires manufactured from stainless steel per ASTM F138 and nitinol per ASTM F2063. The wires are available in lengths of 150-550mm and diameters of .7-1.6mm. The S-wire is available with the following tip styles: Diamond Smooth, Diamond Threaded, Round Smooth, Round Threaded, Trocar Smooth, Trocar Threaded, and Diamond Suture Passer.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "S-Wire." The document does not contain information about an AI/ML device or a study involving acceptance criteria for such a device.

The provided text describes a traditional medical device (fixation pins/wires) and its substantial equivalence to a predicate device based on material, design, and intended use. Therefore, I cannot extract the requested information about acceptance criteria or studies related to AI/ML device performance.

Here's why the requested information cannot be provided from this document:

No AI/ML Device: The S-Wire is a physical orthopedic device made of stainless steel and nitinol. It is not an AI/ML software or system.
No Performance Study as Described: The 510(k) submission establishes substantial equivalence to a predicate device. This typically involves demonstrating similar design, materials, manufacturing, intended use, and performance characteristics (often through bench testing or literature review), not complex clinical trials or detailed performance metrics against acceptance criteria in the way AI/ML algorithms are evaluated.
Lack of Specific Data: There is no mention of sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training sets, or how ground truth for training sets was established, as these are not relevant to the type of device and submission described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the symbol.

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

Spinal Resources, Incorporated % Mr. Kenneth Maxwell Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K152662

Trade/Device Name: S-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: January 29, 2016 Received: February 1, 2016

Dear Mr. Maxwell:

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

{1}------------------------------------------------

Page 2 - Mr. Kenneth Maxwell

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
	See PRA Statement on last page.

Indications for Use

510(k) Number (if known)	K152662
Device Name	S-Wire
Indications for Use (Describe)	The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.

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)
------------------------------------------------------------------------------	--

{3}------------------------------------------------

510(K) SUMMARY

Submitter's Name:	Spinal Resources, Inc.
Submitter's Address:	274 E Eau Gallie Blvd Unit 303Indian Harbour Beach FL 32937
Submitter's Telephone:	904-540-9049
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719. 291.6874
Date Summary was Prepared:	07 March 2016
Trade or Proprietary Name:	S-Wire
Common or Usual Name:	Pin, Fixation, SmoothPin, Fixation, Threaded
Classification:	Class II per 21 CFR §888.3040
Product Code:	HTY and JDW
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

Indications for Use

The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.

The indications for use for the S-wire is similar to that of the predicate device.

Table 5-1 Predicate Device

510kNumber	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K060654	DSI Pins and Wires	Delta Surgical Instruments	Primary

CONCLUSION

The overall technology characteristics and the geometrical analysis comparing the devices leads to the conclusion that the S-wire is substantially equivalent to the predicate device.

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.