The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.

The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.

The design features of the CrossCLIP™ Implant System are summarized below:

Implant Grade Nitinol (ASTM F2063-12) o
O Various sizes to accommodate patient anatomy
o One piece construction
Barbs to resist pull-out O
O Single use, sterile packaged instruments

AI/ML Overview

The provided text is a 510(k) summary for the CrossCLIP™ Implant System, which is a medical device used for bone fixation. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document is a premarket notification from the FDA, confirming substantial equivalence to predicate devices, rather than a detailed scientific study report. It mentions "design verification analysis" and "performance testing" but does not provide the specifics of these tests as requested.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document states: "Results of the design verification activities met the required acceptance criteria." and "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices." However, it does not list the specific acceptance criteria or the reported device performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document refers to "design verification analysis" and "performance testing" but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. This type of information is typically related to diagnostic or imaging device performance where expert review establishes ground truth. The CrossCLIP™ Implant System is a physical bone fixation device, and its performance testing would likely involve biomechanical or material properties testing, not expert interpretation of diagnostic data. The document does not mention any expert review process for establishing ground truth related to its performance studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in diagnostic studies involving inter-reader variability. This document does not suggest such a method was used for the device's performance testing.

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

Not applicable. This document describes a physical medical device (bone fixation implant), not an AI algorithm or a diagnostic aid. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided definitively. Based on the nature of the device (bone fixation implant), "ground truth" for performance testing would typically involve objective biomechanical measurements (e.g., pullout strength, compression force, fatigue life) compared against established standards (like ASTM F2063-12) or predicate device performance. However, the document does not explicitly state the type of ground truth used, only that performance was "verified against the predicate device" and "ASTM F2063-12 Standard Specification."

8. The sample size for the training set

Not applicable. The device is a physical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, no training set for a machine learning model is involved.

Summary of available information from the document:

Device Name: CrossCLIP™ Implant System
Intended Use: Hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Regulatory Status: Substantially equivalent to predicate devices (K070031 and K124045).
Performance Testing Mentioned: "Design verification analysis" and "Performance Testing" against predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
Conclusion of Performance Testing: "The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices."

To answer your request comprehensively, a detailed study report or technical documentation outlining the specific tests performed (e.g., mechanical testing protocols), their results, and the acceptance criteria used would be required, which is not present in this FDA 510(k) clearance letter.

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 stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.

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

October 24, 2014

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

Re: K142727 Trade/Device Name: CrossCLIP™ Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: September 25, 2014 Received: September 30, 2014

Dear Mr. Vernon 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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Page 2 - Mr. Vernon Hartdegen

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 vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142727

Device Name

CrossCLIPTM Implant System

Indications for Use (Describe)

The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Date of Submission	September 25, 2014
Official Contact/Address ofManufacturing Facility	Vernon R HartdegenSr. Vice President of OperationsOrthoDiscovery Group, LLC458 Distribution ParkwayCollierville, TN 38017Phone: 901-221-8406Fax: N/Avhartdegen@crextremity.com
Proprietary Name	CrossCLIP™ Implant System
Device Classification Name	Staple, Fixation, Bone
Product Code	JDR
Classification Reference	21 CFR 888.3030
Classification	Class II
Appropriate Classification Panel	87 - Orthopedic
Predicate Devices	K070031 - MemoMetal Memory Staples (MemoClip - EasyClip -For Fusion); MemoMetal TechnologiesK124045 – FuseForce Implant System; Solana Surgical, LLC
Reason For Submission	New Device

5 – 510(k) Summary CrossCLIP™ Implant System

Substantial Equivalence:

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

Same Operating Principle o
Same Technology o
Same Intended Use o

Design verification analysis was performed on the CrossCLIP™ Implant System as a result of the risk analysis and product requirements. Results of the design verification activities met the required acceptance criteria. In summary, the device described in this submission is substantially equivalent to the predicate device. The subject device is similar in material, operating principle and intended use to both identified predicates. The subject device primarily differs from the predicates in the manner of the attachment of the implant to the insertion

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device/delivery instrument. The predicate devices both rely on insertion/delivery instrumentation and techniques that requires the delivery instrument to attach underneath the bridge of the staple. This prevents the staple from fully seating on the surface of the bone. Due to this, once the staple is released from its inserter and the legs are allowed to converge, the staple must then undergo a final seating with an ancillary instrument. The subject device implant is not held underneath the staple bridge rather the inserter engages the staple leg thereby allowing the implant to be fully seated on the bone prior to being released from the inserter/delivery instrument. Both the subject and predicate devices have barbs on the internal surface of the staple legs to resist pullout. In addition, certain sizes of the subject implant include a barb-like feature on the outside of the staple leg to resist pullout. Neither of these differences adversely affect the safety of the device as demonstrated by the verification analysis. The subject and predicate devices both utilize the same mechanism of action, i.e. the superelastic material property of nitinol, to generate compression between the staple legs. The minor differences between the subject and predicate devices 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 CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Device Description:

The design features of the CrossCLIP™ Implant System are summarized below:

Implant Grade Nitinol (ASTM F2063-12) o
O Various sizes to accommodate patient anatomy
o One piece construction
Barbs to resist pull-out O
O Single use, sterile packaged instruments

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Performance Testing:

The CrossCLIP™ implants have been verified against the predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.