Opening wedge osteotomies of Hallux Valgus
Cotton opening wedge osteotomies
Evans lengthening osteotomies
These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.

Device Description

The 4Web Osteotomy Bone Wedge is a titanium alloy implant used for correction of small bones in the foot. It is offered in two shapes and multiple sizes for each shape with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4-Web truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.

AI/ML Overview

This document describes a 510(k) premarket notification for the 4Web Osteotomy Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a new, innovative device technology (like AI/ML).

Therefore, many of the requested sections regarding AI/ML-specific performance studies are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted from the provided documents:

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

Acceptance Criteria (from predicate device standards)	Reported Device Performance (4Web Osteotomy Bone Wedge)
Static Compression Testing (per ASTM F2077-11)	Indicated substantial equivalence to predicate device and adequacy for intended use.
Dynamic Compression Testing (per ASTM F2077-11)	Indicated substantial equivalence to predicate device and adequacy for intended use.
Expulsion Testing	Indicated substantial equivalence to predicate device and adequacy for intended use.

Explanation: The acceptance criteria are implicitly defined by the performance of the predicate device (Biofoam Bone Wedge from Wright Medical, K073535) and the standards applied to that class of device (ASTM F2077-11). The 4Web Osteotomy Bone Wedge aims to meet or exceed these established performance levels to demonstrate substantial equivalence.

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

This information is not provided in the document. The document refers to "pre-clinical testing" but does not detail sample sizes for the mechanical tests, nor does it refer to patient data.

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 information is not applicable/provided. This device is undergoing a 510(k) submission based on substantial equivalence through mechanical testing, not a clinical study involving expert interpretation of data or images.

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

This information is not applicable/provided. As above, this is a mechanical device submission, not a clinical study requiring adjudication of expert interpretations.

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

This information is not applicable/provided. The document does not describe an AI/ML device, nor a MRMC study.

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

This information is not applicable/provided. The document does not describe an AI/ML device.

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

For the mechanical testing, the "ground truth" is defined by the established performance standards (ASTM F2077-11) and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" mentioned as these are pre-clinical mechanical tests.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of a training set as this is not an AI/ML device.

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

This information is not applicable/provided. There is no mention of a training set or its ground truth establishment.

Summary

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510(k) Summary

Date Prepared:
Contact:

Trade Name:

Product Class:

Classification:

Common Name: Product Codes:

Panel Code:

March 28, 2013 JUN 0 7 2013 Jessee Hunt, President 4Web, Inc. 6170 Research Rd. Suite 219 Frisco, TX 75033 Phone: (800) 285-7090 Fax: 972-488-1816 4Web Osteotomy Bone Wedge Class II 21 CFR §888.3030 Single/multiple component metallic bone fixation appliances and accessories Bone Wedge HRS 87

Indications for Use:

The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation on osteotomies in the foot, such as:

1. Opening wedge osteotomies of Hallux Valgus
1. Cotton opening wedge osteotomies
1. Evans lengthening osteotomies

These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.

Device Description:

Predicate Device(s):

The 4Web Osteotomy Bone Wedge is substantially equivalent to the Biofoam Bone Wedge from Wright Medical (K073535).

Performance Standards:

The pre-clinical testing performed includes static and dynamic compression testing per ASTM F2077-11 and expulsion testing. The results indicate that the 4Web Osteotomy Bone Wedge is substantially equivalent to the predicate device and is adequate for the intended use.

Conclusion:

4Web, Inc concludes that these osteotomy bone wedges are substantially equivalent to the osteotomy bone wedges from Wright Medical and raise no new questions of safety or effectiveness.

ર્દ

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the eagle.

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

June 7, 2013

4Web, Incorporated % Silver Pine Consulting, LLC. Richard Jansen, Pharm. D. Consultant 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K130185

Trade/Device Name: 4Web Osteotomy Bone Wedge 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: March 28, 2013 Received: April 1. 2013

Dear Dr. 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. 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 of medical

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Page 2 - Richard Jansen. Pharm. D.

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 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/Resourcesfor You/Industry/default.htm.

For

Sincerely yours,

Image /page/2/Picture/8 description: The image shows the name "Erin I. Keith" in a stylized font. The letters are bold and black, with a textured or patterned fill. The "I" in the middle has a dot next to it.

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 Statement

Indications for Use

510(k) Number: K130185

Indications for Use:

The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation or osteotomies in the foot, such as:

1. Opening wedge osteotomies of Hallux Valgus
1. Cotton opening wedge osteotomies
1. Evans lengthening osteotomies

These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Elizabet标心班rank -S

Division of Orthopedic Devices

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.