The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

Device Description

The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction.

The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.

The design features of the CrossTie™ Intraosseous Fixation System are summarized below:

Implant Grade PEEK o
Sized to accommodate patient anatomy O
O Solid, one piece construction for all devices
Proximal and distal barb-like features for secure placement o
Hole to optionally aid in joint reduction O

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "CrossTie™ Intraosseous Fixation System". This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way a clinical trial or a performance study for a novel AI/software medical device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this regulatory submission context. This document primarily relies on design verification analysis and material/dimensional evaluation to show equivalence to existing devices.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format with corresponding reported performance for specific metrics. Instead, it relies on demonstrating that "All analyses were verified to meet the required acceptance criteria" and that the device has "substantially equivalent rigidity to the predicate devices" based on "design verification analysis" and "evaluation of the material and dimensions."

Acceptance Criteria	Reported Device Performance
Mechanical integrity under expected loads	"The implant has been cyclic tested to demonstrate that the device can withstand the expected loads." (No specific load values or cycle numbers are provided, nor are specific pass/fail criteria).
Rigidity substantially equivalent to predicate devices	"Evaluation of the material and dimensions demonstrates that the subject device has substantially equivalent rigidity to the predicate devices." (No quantitative metrics for rigidity are provided).
Meeting established product requirements (from risk analysis)	"All analyses were verified to meet the required acceptance criteria." (Specific acceptance criteria and performance against them are not detailed).

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

Sample Size (Test Set): Not applicable for the type of testing described. The document refers to "design verification analysis" and "cyclic tested," which typically involve a limited number of device samples in a laboratory setting, not a "test set" in the context of clinical data or AI validation.
Data Provenance: Not applicable. The testing described is in-vitro mechanical testing.

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

Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

4. Adjudication method for the test set

Not applicable. This information is for clinical or diagnostic AI/software studies, not for the mechanical testing described here.

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. A MRMC study was not done. This device is a surgical implant, not an AI or imaging diagnostic tool.

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

Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

Mechanical Engineering Principles / Industry Standards: The "ground truth" for this device's performance is based on established mechanical engineering principles, material science, and potentially relevant ASTM or ISO standards for medical implants. The goal is to demonstrate that the device's mechanical properties (e.g., strength, rigidity, fatigue resistance) are suitable for its intended use and equivalent to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

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

Not applicable. This information is for AI/machine learning models. The document describes a physical medical device.

Summary of Key Information from the Document:

Device: CrossTie™ Intraosseous Fixation System
Purpose of Submission: New Device 510(k) for substantial equivalence to predicate devices.
Intended Use: Aid in the fixation of fractures, fusions, and osteotomies of the toes (e.g., hammertoe, claw toe, mallet toe, interdigital fusions).
Predicate Devices: K133636 – HammerFix IP Fusion System, K113006 – PhaLinx Hammer Toe System, K120165 - CannuLink Instraosseous Fixation System, K073674 – Kirchner Wires.
Performance Testing Mentioned:
- Design verification analysis performed to meet acceptance criteria derived from risk analysis and product requirements.
- Evaluation of material and dimensions to demonstrate substantially equivalent rigidity to predicate devices.
- Cyclic testing to demonstrate the device can withstand expected loads.
Conclusion: The manufacturer asserts that "minor differences between the subject and predicate devices...are insignificant in the safety and efficacy of the devices" and that the subject device "is substantially equivalent to the predicate devices."

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces or heads. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

January 8, 2015

OrthoDiscovery Group, LLC (D.B.A. CrossRoads Extremity Systems) Mr. Vernon R. Hartdegen Senior Vice President of Operations 458 Distribution Parkway Collierville, Tennessee 38017

Re: K141857

Trade/Device Name: CrossTie™ Intraosseous Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 2, 2014 Received: December 5, 2014

Dear Mr. Hartdegen:

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

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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.

Lori A. Wiggins -S

for 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 Statement

510(k) Number (if known): K141857 (page 1/1)

Device Name: CrossTie™ Intraosseous Fixation System

Indications for Use:

The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation ndication for Use Statement

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Date of Submission	December 2, 2014
Official Contact/Address ofManufacturing Facility	Vernon R HartdegenSr. Vice President of OperationsOrthoDiscovery Group LLC6055 Primacy Parkway, Suite 140Memphis, TN 38119Phone: 901-221-8406Fax: n/avhartdegen@crextremity.com
Proprietary Name	CrossTie™ Intraosseous Fixation System
Device Classification Name	Smooth or threaded metallic bone fixation fastener
Classification Reference	21 CFR 888.3040
Classification	Class II
Appropriate Classification Panel	87 - Orthopedic
Predicate Devices	K133636 – HammerFix IP Fusion System (Extremity Medical)K113006 – PhaLinx Hammer Toe System (OrthoPro)K120165 - CannuLink Instraosseous Fixation System (Orthohelix)K073674 – Kirchner Wires (Signal Medical Corp)
Reason For Submission	New Device

5 - 510(k) Summary CrossTie™ Intraosseous Fixation System

Substantial Equivalence:

The new device has the following similarities to the previously cleared predicate device:

o Same Operating Principle
Same Technology o
Same Intended Use o

Design verification analysis was performed on the CrossTie™ Intraosseous Fixation System as a result of the risk analysis and product requirements. All analyses were verified to meet the required acceptance criteria. The subject device is most similar in material, indications and technical characteristics to the HammerFix (K133636 – Extremity Medical) predicate. It is similar in indications to the PhaLinx Hammer Toe (K113006 – OrthoPro) and the CannuLink System (K120165 – Orthohelix) but is not manufactured from titanium alloy. The subject CrossTie™ implant does not have a split end as the previously mentioned predicates (K133636 –

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HammerFix IP Fusion System; K113006 – PhaLinx Hammer Toe System; & K120165 – CannuLink Instraosseous Fixation System). The non-split end of the CrossTie™ implant is intended to ensure a more predictable interface with the bone. Even though, there are minor differences between the subject and predicate devices, those differences are insignificant in the safety and efficacy of the devices. In summary, the subject device described in this submission is substantially equivalent to the predicate devices.

Indications for Use:

The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and interdigital fusions

Device Description:

The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.

The design features of the CrossTie™ Intraosseous Fixation System are summarized below:

Implant Grade PEEK o
Sized to accommodate patient anatomy O
O Solid, one piece construction for all devices
Proximal and distal barb-like features for secure placement o
Hole to optionally aid in joint reduction O

Performance Testing:

The CrossTie™ Intraosseous Fixation System device utilizes materials and has design features that are the same as the predicate devices. Evaluation of the material and dimensions demonstrates that the subject device has substantially equivalent rigidity to the predicate devices. The implant has been cyclic tested to demonstrate that the device can withstand the expected loads.

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.