The 2-Piece Hammertoe Correction System is a two-piece construct, each with a threaded shaft that is inserted in the proximal and middle phalanges, so that each implants threads fixate on the phalangeal canal of the toe and stabilize the joint. The implant is fabricated and manufactured from the following: 1) Titanium (Ti 6A1-4V ELI). All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "2-Piece Hammertoe Correction System." This document is a regulatory filing with the US FDA and does not contain detailed acceptance criteria, study data, or performance metrics in the way your request describes for assessing AI or diagnostic device performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, including:

A table of acceptance criteria and the reported device performance: This document is a clearance letter, not a detailed study report.
Sample size used for the test set and the data provenance: Not applicable; no such test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this is a hardware device, not an AI or diagnostic tool.
If a standalone performance study was done: "Bench Top Validations" and "Custom Shear Testing" were performed for substantial equivalence, but the details (like specific performance metrics, sample sizes, or results against acceptance criteria) are not provided.
The type of ground truth used: Not applicable in the context of device performance metrics for diagnostic accuracy. For a mechanical device, performance would relate to strength, durability, biocompatibility, etc.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does provide is:

Device Name: 2-Piece Hammertoe Correction System
Indications for Use: "for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes."
Material: Titanium (Ti 6A1-4V ELI) manufactured according to ASTM F136.
Performance Data Mentioned: "Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System." This indicates that some form of testing was done to support the claim of substantial equivalence to predicate devices, but the specific results and acceptance criteria are not detailed in this public FDA letter.
Conclusion: The information demonstrates substantial equivalency.

This document serves as an FDA clearance letter based on a 510(k) submission, confirming that the device is substantially equivalent to a predicate device. It does not typically include the granular details of performance studies or acceptance criteria that would be found in a full clinical trial report or a detailed engineering validation document.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

June 9, 2017

Life Spine, Inc. Randy Lewis General Manager 13951 S. Quality Drive Huntley, Illinois 60142

Re: K162685

Trade/Device Name: 2-piece Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2017 Received: May 12, 2017

Dear Randy Lewis:

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 devicerelated 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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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/ResourcesforYou/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,

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

510(k) Number (if known) K162685

Device Name

2-Piece Hammertoe Correction System

Indications for Use (Describe)

The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

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)

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510(k) Summary 2-Piece Hammertoe Correction System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	May 11th, 2017
Trade Name:	2-Piece Hammertoe Correction System
Common Name:	Intramedullary Bone Screw
Regulation Name:	Smooth or Threaded Metallic Bone Fixation Fastener
Classification:	HWC, CFR 888.3040, Class II
Primary Predicate:	Arthrosurface Hammertoe Correction System (K130859)
Secondary Predicate:	Hammertoe Correction System (K153065)Wright Medical PhaLinx (K142585)Arthrex BioPin (K050259)Gramedica Opti-Toe (K142478)Pioneer Surgical Technology Stayfuse (K990804, K022726)

Device Description:

Titanium (Ti 6A1-4V ELI)

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the 2-Piece Hammertoe Correction System components with components from any other system or manufacturer. The 2-Piece Hammertoe Correction System components should never be reused under any circumstances.

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K162685 PAGE 2 OF 2

Indications for Use of the Device:

The 2-Piece Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Technological Characteristics:

The 2-Piece Hammertoe Correction System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.

Material:

The 2-Piece Hammertoe Correction System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of non-sterile titanium, single use components.

Performance Data:

Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the 2-Piece Hammertoe Correction System.

Conclusion:

The information presented demonstrates the substantial equivalency of the 2-Piece Hammertoe Correction System.

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.