The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

Device Description

The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Sola Fix Twist Screw Implant System" by Solana Surgical, LLC. The summary focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software product. Therefore, much of the requested information regarding AI device studies (like sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not applicable.

Here's an analysis based on the provided text, adapted to the context of a mechanical device submission:

Acceptance Criteria and Device Performance

Since this is a submission for a mechanical implant, the "acceptance criteria" are typically defined by recognized standards for mechanical testing and comparison to an already marketed predicate device. The "device performance" is demonstrated by meeting these standards and showing comparable characteristics.

Acceptance Criterion	Reported Device Performance	Comments
Mechanical Testing per ASTM F543	Mechanical testing was performed according to ASTM F543.	This standard likely specifies various mechanical properties (e.g., tensile strength, fatigue life, torsional strength) that the screw must meet. The document states it was performed, implying successful adherence to the standard's requirements to demonstrate safety and efficacy.
Engineering/Dimensional Comparison to Predicate Device	An engineering/dimensional comparison to the predicate device was performed.	This implies that the Sola Fix Twist Screw Implant System is dimensionally and structurally similar enough to the predicate device (Charlotte Snap-Off Screw, K050819) to justify "substantial equivalence."
Material Composition	Made of Titanium Alloy; No new materials.	The device uses industry-standard Titanium Alloy, the same or similar to the predicate, ensuring biocompatibility and established mechanical properties.
Intended Use	"Intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot."	The intended use statement is identical or highly similar to the predicate device, a key aspect of demonstrating substantial equivalence.
Device Configuration	One-piece device; Screw driving portion separates from screw head; Available in a range of sizes (2.0mm diameter, 11-16mm length).	These characteristics were compared to the predicate to ensure similar functionality and application.

Important Note: The document explicitly states: "Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant." This is the overarching "performance" claim for a 510(k) for a mechanical device – demonstrating substantial equivalence, not novel performance metrics.

Study Information (as applicable to a mechanical device)

Given this is a 510(k) for a mechanical bone fixation screw, the concepts of "test set," "training set," "experts," "adjudication," "MRMC studies," and "standalone performance" as they relate to AI/software are not applicable. The "study" here refers to the mechanical and comparative analyses performed.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of AI/software. For mechanical testing, the "sample size" would refer to the number of screws subjected to testing (e.g., N=5 or N=10 per test). This specific number is not provided in the summary but would be detailed in the full 510(k) submission.
- Data Provenance: Not applicable in the AI/software sense. The data comes from in vitro mechanical testing performed in a lab setting, likely by or for Solana Surgical, LLC.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through adherence to engineering standards (e.g., defining load limits, dimensions) and comparison to a legally marketed predicate. There isn't an "expert consensus" on an image or clinical case.
Adjudication method for the test set: Not applicable. Adjudication is not relevant for compliance with mechanical engineering standards.
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 is not an AI-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical properties.
The type of ground truth used: For this type of device, the "ground truth" is adherence to established mechanical engineering standards (ASTM F543) and factual engineering/dimensional data for comparison to the predicate. The "truth" is whether the device meets the specified mechanical properties and is sufficiently similar to an already approved device.
The sample size for the training set: Not applicable. There is no training set for a mechanical device.
How the ground truth for the training set was established: Not applicable.

Summary

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K120390 '/2

APR 1 0 2012

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510(k) Summary

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

Prepared: Applicant:

Contact:

February 6, 2012 Solana Surgical, LLC 6363 Poplar Ave, Suite 434 Memphis. TN 38119 Louise Focht 901-818-1860

Common Name: Device Trade Name: Device Classification Name:

Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:

Screw, fixation, bone Sola Fix Twist Screw Implant System Smooth or threaded metallic bone fixation fastener. Class II Orthopedic 21 CFR 888.3040 HWC K050819 Charlotte Snap-Off Screw

Device Description:

Intended Use:

The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

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Technological Characteristics:

Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate substantial equivalence. Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant.

Substantial Equivalence - Non-Clinical Evidence:

Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate safety and efficacy. The devices were also evaluated to demonstrate they performed as expected.

Conclusions:

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, 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 evaluations performed and data provided in this application demonstrate that the Solana Surgical device is substantially equivalent to the predicate device.

K120390

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 an abstract symbol resembling a stylized caduceus or a representation of human figures.

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

APR 1 0 2012

Solana Surgical, LLC % Ms. Louise Focht 6363 Poplar Avenue Suite 434 Memphis, TN 38119

Re: K120390

Trade/Device Name: Sola Fix Twist Screw Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 6, 2012 Received: February 7, 2012

Dear Ms. Focht:

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 i that FDA has made a determination that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must or any I cacial statures and registments, including, but not limited to: registration and listing (21 comply with an the Fee brequirements 801); medical device reporting (reporting of medical

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Page 2 - Ms. Louise Focht

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

Enclosure

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Indications for Use

510(k) Number (if known): K/20390 Device Name: Sola Fix Twist Screw Implant System Indications for Use:

The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120390

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.