The Solana Surgical LLC, CrossCheck Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet, wrist, and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.

Device Description

The Solana Surgical, LLC CrossCHECK Plating System consists of a variety of bone plates and screws to be used in fixation fractures, osteotomies, and fusions in the extremities of the ley and arm including the hand and foot. The various plate designs use either 3mm or 3.5mm screws. Screws include both locking and non-locking designs. Lag screws and cross-hole plates are included for compression. Plate designs include MTP, Lapidus, and 2-7 Hole Utility plates. All plates and screws are manufactured from ASTM F136 Ti-6A1-4V ELI alloy. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

AI/ML Overview

The provided text describes Solana Surgical, LLC's CrossCheck Plating System, a device for stabilizing and fixing bone fractures, osteotomies, and fusions in the extremities. The 510(k) summary indicates that the device's substantial equivalence determination is based on a comparison to predicate devices, focusing on materials, design, and intended use.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Metric	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Material Properties	The plates and screws must be manufactured from ASTM F136 Ti-6A1-4V ELI alloy.	"All plates and screws are manufactured from ASTM F136 Ti-6A1-4V ELI alloy."	Device description in section 6 confirms the use of specified material. No specific testing report details are provided in this summary, but the statement confirms adherence to the material specification.
Mechanical Performance of Plates	Plates must meet the "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382.	"The subject device met acceptance criteria..." when evaluated per ASTM F382.	Summary of Device Testing in section 1 states that the plates were evaluated per ASTM F382, and "The subject device met acceptance criteria and is substantially equivalent to the predicates." This implies the mechanical properties (e.g., bending strength, stiffness) were comparable to, or better than, the predicate devices and met the standard.
Mechanical Performance of Screws	Screws must meet the "Standard Specification and Test Methods for Metallic Medical Bone Screws" as per ASTM F543-07.	"The subject device met acceptance criteria..." when evaluated per ASTM F543-07.	Summary of Device Testing in section 1 states that the screws were evaluated per ASTM F543-07, and "The subject device met acceptance criteria and is substantially equivalent to the predicates." This implies the mechanical properties (e.g., torque strength, pull-out strength, bending properties) were comparable to, or better than, the predicate devices and met the standard.
Substantial Equivalence to Predicate Devices	The device should demonstrate comparable technological characteristics, principles of operation, mechanisms of action, size, materials (no new materials introduced), and intended use as the predicate devices.	"The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.""The technological characteristics, principles of operation and mechanisms of action are the same as the predicates.""The subject device met acceptance criteria and is substantially equivalent to the predicates."	Comparison to Predicate Device in section 1, along with the device description and summary of device testing, collectively state that the device is similar in design, materials, principles of operation, and met safety and performance criteria through testing against ASTM standards, using examples from predicate devices for comparison.

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

The provided 510(k) summary does not specify the sample size used for the mechanical testing (devices tested) or the provenance of any data (country of origin, retrospective/prospective). It only states "Examples from the predicate device systems were used for comparison." This suggests a comparative physical testing approach rather than a data-driven clinical study with a "test set" of patient data.

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

This information is not provided in the document. The study described is primarily a mechanical device performance test against established ASTM standards and a comparison to predicate devices, not a study requiring expert consensus or clinical ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The study described is a laboratory-based mechanical performance test, not a clinical study involving human assessment or expert adjudication of outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The 510(k) summary focuses on the mechanical and material equivalence of the device to existing predicate devices through laboratory testing. It does not involve human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. This device is a bone plate and screw system, a physical medical device, not a software algorithm or an AI-based system.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on established engineering standards and material specifications, specifically:

ASTM F382: Standard Specification and Test Method for Metallic Bone Plates.
ASTM F543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws.
Material Specification: ASTM F136 Ti-6A1-4V ELI alloy for the manufacturing material.

The performance of predicate devices also serves as a benchmark for comparison during the testing. This is a technical, rather than a clinical or pathological, ground truth.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As this is a physical medical device and not an AI/software system, there is no "training set."

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

This information is not applicable and therefore not provided. There is no training set for this type of device submission.

Summary

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K132594

DEC 13 2013

6. 510(k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared: Applicant:

August 15, 2013 Solana Surgical, LLC 6363 Poplar Ave, Suite 312 Memphis, TN 38119 Joe Clift (Contact) jclift@solanasurgical.com (901) 818-1860

Common Name: Device Trade Name: Device Classification Name:

Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device(s):

Plate, Fixation, Bone CrossCheck Plating System Single/Multiple component metallic bone fixation appliances and accessories Class II Orthopedic 21 CFR 888.3030 HRS Memometal Anchorage Bone Plate System: K083447 Integra Total Foot System K123000

Device Description:

Indications for Use:

K132594 - 510(k) Summary - Revised November 21, 2013

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Comparison to Predicate Device:

Similarities of the Solana Surgical device to its predicates include these devices being: intended for single use only, intended for surgical implantation longer than 30 days, a system consisting of a series of implants, made of industry standard materials, with no new materials being introduced in the product, comparably sized, and indicated for the same uses. The technological characteristics, principles of operation and mechanisms of action are the same as the predicates.

Summary of Device Testing:

The plates and screws of the subject device were evaluated per ASTM F382 "Standard Specification and Test Method for Metallic Bone Plates" and ASTM F543-07 "Standard Specification and Test Methods for Metallic Medical Bone Screws". Examples from the predicate device systems were used for comparison. The subject device met acceptance criteria and is substantially equivalent to the predicates.

K132594 - 510(k) Summary - Revised November 21, 2013

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 13, 2013

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

Solana Surgical, LLC Mr. Joe Clift Senior Vice President Quality & Regulatory 6363 Poplar Avenue, Suite 312 Memphis, Tennessee 38119

Re: K132594 Trade/Device Name: CrossCheck Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 21, 2013 Received: November 22, 2013

Dear Mr. Clift:

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. Ilisting 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

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Page 2 - Mr. Joe Clift

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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 NiMelkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

1 Rail- 13-12-2018

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k} Number (if known) K132594

Device Name CrossCheck Plating System

Indications for Use (Describe)

The Solana Surgical LLC, CrossCheck Plating System is indication and fixation of frash fractures, revision procedures, joint fixsion and reconstruction of small bones in the hand, fee, wrist, and toes. The system may be used in both pediatric and adult patients.

The device is intended for single use.

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

[2] 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) (Stignature)

Elizabeth L. Frank -S

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

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.