The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Device Description

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

AI/ML Overview

This document is a 510(k) summary for the Hammertoe Truss System (HTS). It indicates that the purpose of the submission is to update the HTS implant offering to include two smaller sizes. The document outlines the device description, indications for use, and a comparison to predicate devices, focusing on the mechanical properties and MRI compatibility.

Here's an analysis based on your request, keeping in mind that the document mainly focuses on mechanical performance and equivalence to a predicate device, rather than a clinical study with patients or human readers.

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

Acceptance Criteria	Reported Device Performance
Mechanical Properties:
Finite element analysis: No new worst-case implant compared to previously cleared devices.	Validated finite element analysis demonstrated that the additional implant sizes for the Hammertoe Truss System (HTS) do not create a new worst-case implant compared to the previously cleared 4WEB Hammertoe Truss System devices for mechanical properties of the device.
ASTM F1264: Static and Dynamic 3-Point Bend and Torque to Failure	Performance completed per this standard (specific values not provided but implied to meet acceptance for substantial equivalence).
ASTM F543: Axial Push Out	Performance completed per this standard (specific values not provided but implied to meet acceptance for substantial equivalence).
MR Conditional Testing (based on reference predicate):
ASTM F2119: MR Image Artifact	Hammertoe Truss System does not present a new worst case compared to the reference predicate which met this standard.
ASTM F2052: MR Induced Displacement Force	Hammertoe Truss System does not present a new worst case compared to the reference predicate which met this standard.
ASTM F2213: MR Induced Torque	Hammertoe Truss System does not present a new worst case compared to the reference predicate which met this standard.
ASTM F2182: MR Induced Heating	Hammertoe Truss System does not present a new worst case compared to the reference predicate which met this standard.

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

This submission describes engineering performance testing and simulation analysis, not a clinical study on a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" in a clinical context are not applicable. The testing was done on physical device prototypes or through computer-simulated models.

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)

This is not applicable as the submission reports on mechanical and MRI compatibility testing of a physical device, not a diagnostic or AI-driven system requiring expert review of medical images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in clinical trials or diagnostic accuracy studies.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the safety and effectiveness of a physical implantable device based on mechanical and MRI compatibility testing, demonstrating substantial equivalence to a predicate device. It does not involve AI or human readers.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (implant).

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

The "ground truth" for this type of submission is based on engineering standards and established test methods (e.g., ASTM standards) for evaluating the mechanical properties and MRI compatibility of medical implants. The "truth" is whether the device physically performs in accordance with these validated standards and demonstrates similar characteristics to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and extensive bench testing.

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

This is not applicable for the reasons mentioned in point 8.

Summary

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September 6, 2022

4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905

Re: K221283

Trade/Device Name: Hammertoe Truss System (HTS) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: July 13, 2022 Received: July 15, 2022

Dear Richard Jansen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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: January 31, 2017 See PRA Statement below

510(k) Number (if known)

K221283

Device Name: Hammertoe Truss System (HTS)

Indications for Use (Describe)

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)
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FOR FDA USE ONLY

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510(k) Summary

Date Prepared:	April 22, 2022
Contact:	Jessee Hunt, President4WEB, Inc.2801 Network Blvd., Suite 620Frisco, TX 75034Phone: (800) 285-7090Fax: 972-488-1816
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consulting, LLCrichj@s-pineconsulting.com
Trade Name:	Hammertoe Truss System (HTS)
Product Class:	Class II
Classification:	21 CFR §888.3040
Common Name:	Smooth or threaded metallic bone fixation fastener
Product Codes:	HTY
Panel Code:	87

Purpose:

The purpose of this submission is to update the Hammertoe Truss System (HTS) implant offering to include two smaller sizes in both the 0 degree plantarflexion angulation options.

Indications for Use:

The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Device Description:

Predicate Device(s):

The primary predicate device is the 4WEB Medical Hammertoe Truss System (K190926). The reference predicates are the 4WEB Medical Lateral Spine Truss System (K172392, K211388).

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Performance Standards:

Validated finite element analysis demonstrated that the additional implant sizes for the Hammertoe Truss System (HTS) do not create a new worst-case implant compared to the previously cleared 4WEB Hammertoe Truss System devices for mechanical properties of the device.

Performance testing has been completed per the following standards for the combined Hammertoe Truss System (HTS):

ASTM F1264 Static and Dynamic 3-Point Bend and Torque to Failure .
ASTM F543 – Axial Push Out

MR Conditional testing listed below is from the reference predicate device, the 4WEB Lateral Spine Truss System (K173159). The Hammertoe Truss System does not present a new worst case.

. ASTM F2119 – MR Image Artifact
ASTM F2052 – MR Induced Displacement Force
ASTM F2213 – MR Induced Torque
ASTM F2182 – MR Induces Heating

Technological Characteristics:

4WEB, Inc. has compared these devices to the previously cleared predicate devices regarding indications for use, materials, function, sizes and simulated testing. These comparisons demonstrate substantial equivalence to the predicate devices.

Conclusion:

4WEB, Inc. concludes that the HTS device is substantially equivalent to the predicate devices.

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.