The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

Device Description

The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.

AI/ML Overview

The provided text is for a 510(k) summary for a medical device called the "Gaitway Implant System," a subtalar arthroereisis implant. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study in the same way a PMA (Pre-Market Approval) study would.

Therefore, many of the typical acceptance criteria and study details for a software-based or diagnostic device are not applicable to this type of submission. This 510(k) focuses on equivalence in material, geometry, and intended use.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This table is not applicable in the traditional sense of a clinical study with performance metrics for diagnosis or treatment efficacy like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) for an implantable device like this revolved around demonstrating substantial equivalence to predicate devices in terms of:

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (from 510(k))
Material Composition	Identical to Memometal and Instratek predicate devices (Titanium Alloy).
Mechanical Strength Characteristics	"Greatly exceeds the mechanical strength characteristics of the Arthrex device" (which is made of PLLA). "Equivalent or greater strength" than predicates.
Geometry/Design	Similar to predicate devices; conical shape to fit sinus tarsi. Cannulated.
Indications for Use	Intended to treat hyperpronated foot and stabilize the subtalar joint, blocking forward/medial talus displacement and excessive pronation. This matches the function described for predicate devices.
Manufacturing/Usage Attributes	One-piece, range of sizes (6.5mm to 11.5mm), single use, surgical implantation longer than 30 days, placed into subtalar sinus tarsi. Consistent with predicate devices.

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

Sample Size: Not applicable. This 510(k) is based on a comparison to predicate devices, not a clinical trial with a "test set" of patients in the way a diagnostic device would have a test set of images or cases. The evaluation is primarily bench testing of material properties and design comparison.
Data Provenance: Not applicable. There is no patient data involved in demonstrating substantial equivalence in this context. The data comes from engineering specifications and comparisons to existing devices.

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

Not applicable. There is no "ground truth" to establish for a test set of patients or data in this type of 510(k) submission. The evaluation is based on engineering principles and regulatory equivalence.

4. Adjudication Method for the Test Set

Not applicable. No test set or human adjudication process is described or required for this type of submission.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is an implantable device, and such a study is not part of its 510(k) pathway.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. This is an implantable medical device, not an algorithm or software. Therefore, "standalone performance" in that context is not applicable. The device itself performs its intended function in the body.

7. The Type of Ground Truth Used

Not applicable. For this 510(k), the "ground truth" equivalent would be established engineering and material science principles, and the regulatory understanding of what constitutes a safe and effective implant based on the performance of legally marketed predicate devices. There's no pathology, expert consensus, or outcomes data used to establish ground truth for a test set in this application.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve machine learning or AI algorithms with "training sets."

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

Not applicable. As above, no training set is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" described in the 510(k) summary is a comparative analysis of the Solana Surgical Gaitway Implant System against three legally marketed predicate devices:

Memometal SubFix Arthroereisis Implant (K093820)
Instratek, INC. Sub-Talar Lok, Model 7-11 mm (K080280)
Arthrex Pro Stop Plus (K071456)

The primary method of demonstrating that the device meets "acceptance criteria" (i.e., is substantially equivalent) involves:

Direct Comparison: The applicant explicitly states that "The design of the Solana Surgical implant is similar to the predicate devices."
Material Equivalence/Superiority: The device is constructed of Titanium Alloy, which is "identical to the Memometal and Instratek devices." It is also stated that it "greatly exceeds the mechanical strength characteristics of the Arthrex device" (which is PLLA).
Geometric Equivalence: All compared devices (Solana Surgical and predicates) are "conical in shape so as to fit into the anatomy of the sinus tarsi" and are "cannulated to accept a guide wire."
Indications for Use Equivalence: The indications for use of the Gaitway Implant System are presented, and the summary implies their consistency with the predicate devices: "Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation."
Manufacturing and Usage Parameter Equivalence: All devices are for single use, surgical implantation longer than 30 days, and placed into the subtalar sinus tarsi.

The conclusion drawn by the applicant, and presumably accepted by the FDA based on the approval letter, is: "Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness."

The FDA's letter (K122738) confirms their review and determination that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination serves as the "proof" that the device meets the necessary acceptance criteria for market clearance under the 510(k) pathway.

Summary

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K122738 (pg. i of 2.)

Section 5. - 510(k) Summary

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

Prepared: Applicant: August 31, 2012 Solana Surgical, LLC 6363 Poplar Ave, Suite 434 Memphis, TN 38119 Phone: (901) 818-1860 Fax: (855) 540-1861 Contact: Rebecca Wahl

Common Name: Device Trade Name: Device Classification Name:

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

Subtalar Arthroereisis Implant Gaitway Implant System Smooth or threaded metallic bone fixation fastener. Class II Orthopedic 21 CFR 888.3040 HWC K093820 Memometal SubFix Arthroereisis Implant K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K071456 Arthrex Pro Stop Plus

Device Description:

Indications for use:

Summary Comparison to Predicate Devices:

The Solana Surgical device is similar to the Memometal Subfix™ Subtalar Arthroereisis Implant (K093820), the Instratek, Inc. Sub-Talar Lok, Model 7-11 mm (K080280) and the Arthrex Pro Stop Plus (K071456). Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation. The Memometal and Instratek devices are made of titanium alloy and the Arthrex device is made of Poly L - Lactide (PLLA). The Solana Surgical, Memometal, Instratek and Arthrex devices are conical in shape so as to fit into the anatomy of the sinus tarsi. Each system is cannulated to accept a guide wire for ease of Solana Surgical - October 18, 2012

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)4122738

implantation. All devices are: intended for single use only; intended for surgical implantation longer than 30 days; are placed into the subtalar sinus tarsi.

Indications for use, geometry and material composition were considered in evaluating safety and effectiveness relative to predicate devices. The subject device is constructed of material that is identical to the Memometal and Instratek devices and greatly exceeds the mechanical strength characteristics of the Arthrex device. Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 7, 2012

Solana Surgical, LLC % Rebecca Wahl Vice President Research and Development 6363 Poplar Ave. Suite 434 Memphis, Tennessee 38119

Re: K122738

Trade/Device Name: Gaitway Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC · Dated: August 31, 2012 Received: September 6, 2012

Dear Ms. Wahl:

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 for ass stated in the energean of 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 or any 1 ederal statute and 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 - Ms. Wahl

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device thated adverse overse (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 rr you acce//www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation emailing 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 Tou may obtain 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 N. Melkerson

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): _ | 122738 Device Name: Gaitway Implant System Indications for Use:

The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated The Solana Surgical EDC, Guttway implants of earling of the marked to block forward and 1001 and Submize the Subanar John. 11-19-19-19-19 to and the resulting sequela.

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)

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

1122738 510(k) Number _

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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.