This document is a 510(k) premarket notification for the Tornier ForeFoot STP System, a medical device. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. Based on the provided text, a "study" in the context of device performance refers to mechanical testing rather than a clinical study or a study involving AI/software analysis of data.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format for this 510(k) submission. However, it mentions the types of tests performed and the conclusion that the device is substantially equivalent based on these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent strength in cross-sectional bending	Cross-sectional bending analysis performed; results support substantial equivalence to predicate devices.
Equivalent strength in mechanical axial pull-out	Mechanical axial pull-out testing performed; results support substantial equivalence to predicate devices.
Appropriate torsional strength	Mechanical testing was completed to ensure that the torsional strength is appropriate for the potential applications of the device.
Appropriate insertion torque	Mechanical testing was completed to ensure that the insertion torque is appropriate for the potential applications of the device.
Appropriate removal torque	Mechanical testing was completed to ensure that the removal torque is appropriate for the potential applications of the device.
Overall safety and effectiveness compared to predicate devices	Demonstrated to be as safe and effective as the predicate devices due to similarities in indications, design, and materials, supported by mechanical testing.

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

This document describes mechanical testing of a physical medical device (screws), not a study analyzing data (like images or patient records). Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) and sample size for data analysis does not directly apply.

The "sample size" would refer to the number of physical screws tested in the mechanical evaluations. This information is not provided in the document.
"Data provenance" is not applicable as this concerns mechanical properties of the device itself, not clinical or image data.

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

This is not applicable. The "ground truth" for mechanical testing of screws is defined by the physical properties of the materials and the engineering standards for such devices. It does not involve expert interpretation in the way clinical or imaging studies do.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objective measurements based on engineering principles and test protocols, not subjective interpretations requiring adjudication.

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. This submission is for a physical medical device (fixation screws), not an AI or software-based medical device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the mechanical testing of the ForeFoot STP System would be based on engineering standards and established material properties for bone fixation devices. The performance is compared against the known performance of the predicate devices, which also comply with these engineering standards. The focus is on demonstrating equivalent mechanical strength and characteristics.

8. The Sample Size for the Training Set

This is not applicable. This refers to a physical medical device, not an AI or software-based system that uses a "training set."

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

This is not applicable. This refers to a physical medical device, not an AI or software-based system.

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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other.

August 4, 2015

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

Tornier, Incorporated Brian Hockett Director of Research and Development- Lower Extremity 1065 Medina Road, Suite 500 Medina. Ohio 44256

Re: K150871

Trade/Device Name: ForeFoot STP System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 2, 2015 Received: July 6, 2015

Dear Mr. Hockett:

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 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.

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Page 2 - Mr. Brian Hockett

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" (21 CFR 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K150871

Page 1 of 1

510(k) Number (if known) K150871

Device Name ForeFoot STP System

Indications for Use (Describe)

The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CER 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Submitter Information

Submitter's Name:	Tornier, Inc.
Address:	1065 Medina Rd, Suite 500Medina, Ohio 44256
Telephone Number:	330-869-9562
Fax Number:	330-247-1598
Prepared By:	Liz Altenau, Andy Leither
Contact Person:	Brian Hockett
Date Prepared:	3/12/2015
Device Information
Trade Name:	ForeFoot STP System
Common Name:	Fixation Screws
Classification Name:	Screw, Fixation, Bone
Device Classification:	Smooth or threaded metallic bone fixation fastenerClass II per 21 CFR 888.3040Panel: Orthopedic, Product Code: HWC
Material Composition:	Titanium Alloy
Primary Predicate Device:	Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, K014154
Additional Predicate Devices:	SBI AutoFix System, K052576OrthoHelix MaxTorque System, K131324Nexa Bone Screw System, K053394
Device Description:	The submission is regarding the ForeFoot STP System. This system consists ofscrews of various diameters, lengths and thread configurations.
Indications for Use:	The Tornier ForeFoot STP Screw System is indicated for fixation of fractures,fusions, and osteotomies of bones of the hand and foot.
Substantial Equivalence:	The Tornier ForeFoot STP screws are substantially equivalent to the previouslycleared predicate devices. Cross-sectional bending analysis and mechanicalaxial pull-out testing comparing the strength of the subject and predicatedevices was performed and the results support substantial equivalence.Mechanical testing was completed to ensure that the torsional strength,insertion torque, and removal torque are appropriate for the potentialapplications of the device. Due to similarities in indications, design, andmaterials, no other testing was required; therefore, the subject device wasdemonstrated to be as safe and effective as the above predicates.

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.