The Solana Surgical LLC, Lesser Metatarsal Head Implant System is intended for use as a hemiarthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

Device Description

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the metatarsal bone at the lesser metatarsal phalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the lesser metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal lesser metatarsal. 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

This looks like a 510(k) premarket notification for a medical device called the "Lesser Metatarsal Head Implant System." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device or a PMA.

Therefore, the information requested in your prompt related to acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies is not typically found in a 510(k) summary like this one.

Here's a breakdown of why and what information is available:

Response to your Request:

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

Not Applicable. This 510(k) summary does not include specific acceptance criteria for a device performance study in the way a clinical trial or performance study for an AI/diagnostic device would. The "performance" being evaluated is primarily the mechanical strength and material properties in comparison to predicate devices, not clinical efficacy or diagnostic accuracy.
The summary states: "An engineering analysis was performed to evaluate the mechanical strength of subject and predicate device implant stems." and "The titanium plasma spray coating process as applied to the Solana Surgical device has been thoroughly evaluated for morphological and strength characteristics." These are the "reported device performance" aspects, but without specific quantitative acceptance criteria disclosed in this summary.

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

Not Applicable / Not Provided. No clinical test set data from actual patients is described or used in this 510(k) summary to prove performance against specific clinical acceptance criteria. The evaluation is focused on engineering analysis and comparison to predicate devices.

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. No ground truth establishment by experts is described, as there are no clinical test sets or diagnostic performance claims requiring expert interpretation.

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

Not Applicable. No test set requiring expert adjudication is described.

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 device is a mechanical implant, not an AI software or diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This is a mechanical implant, not an algorithm.

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

Not Applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "ground truth" for the engineering evaluation would be established engineering principles, material science standards, and comparison with the known properties of the predicate devices.

8. The sample size for the training set

Not Applicable. This is a mechanical implant; there is no "training set" in the context of machine learning or AI.

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

Not Applicable. No training set exists for this type of device submission.

Summary of Available Information from the Provided Text:

Device Name: Lesser Metatarsal Head Implant System
Purpose: Hemiarthroplasty implant for the metatarsophalangeal joint.
Materials: Cobalt Chromium (with titanium plasma spray coated stem).
Design: One-piece device with an articulating surface and a stem for intramedullary canal insertion.
Comparison Basis: Substantially equivalent to predicate devices (OsteoMed: K073065, Vilex: K102401) based on:
- Similar materials
- Similar indications for use
- Comparable sizing
- Similar intended use (single use, surgical implantation longer than 30 days)
- Engineering analysis of mechanical strength (comparison of subject and predicate device implant stems).
- Evaluation of the titanium plasma spray coating process for morphological and strength characteristics.

This document serves to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering comparisons and material analysis, rather than extensive clinical efficacy studies with predefined acceptance criteria.

Summary

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KI31187

5. 510(k) Summary

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

Prepared: Applicant:

April 3, 2013 Solana Surgical, LLC 6363 Poplar Ave, Suite 312 Memphis, TN 38119 Joe Clift (Contact) (901) 818-1860

OCT 2 2 2013

Common Name:	Toe joint, lesser metatarsal (hemi-toe)prosthesis
Device Trade Name:	Lesser Metatarsal Head Implant System
Device Classification Name:	Toe joint metatarsal (hemi-toe) polymerprosthesis
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number:	21 CFR 888.3730
Product Code:	KWD
Predicate Device(s):	OsteoMed: K073065Vilex: K102401

Device Description:

Indications for Use:

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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, 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.

An engineering analysis was performed to evaluate the mechanical strength of subject and predicate device implant stems.

The titanium plasma spray coating process as applied to the Solana Surgical device has been thoroughly evaluated for morphological and strength characteristics.

Based on the comparable materials used, indications for use, testing and analysis, the Solana Surgical device is substantially equivalent to the predicate devices.

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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 20993-0002

October 22, 2013

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

Re: K131187

Trade/Device Name: Lesser Metatarsal Head Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: September 6, 2013 Received: September 9, 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, 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. Joe Clift

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 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/ReportalProblem/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.

Sincercly yours,

Erin® Keith

for

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

Enclosure

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4. Indications for Use Statement

510(k) Number (if known): K131187 Device Name: Lesser Metatarsal Head Implant System Indications for Use:

The device is intended for single use to be used with bone cement or press fit without bone cement.

Prescription Use Over-The-Counter Use ਮ AND/OR (Part 21 CFR 801 Subpart D) (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 (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.