E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT by SIGNAL MEDICAL CORP.

Triple arthrodesis
Isolated rearfoot arthrodesis
Midfoot arthrodesis
Comminuted trauma
Diabetic Charcot reconstruction
Most foot pathology not requiring fixation above the ankle

Device Description

The E-Z Frame Surgical Boot is manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post surgical conditions. Presently liizarov or Sheppard Rings are used for this purpose and require multiple avenues of surgical intervention in the tibia to stabilize the distal support ring. With the E-Z Frame system a boot is stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully. Light weight materials are employed using 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate and small ASTM F 17-4 Stainless Steel Fixtures. The foot is stabilized to the distal ring using Kirshner Wires (K-Wire) purchased from PROMEX of Indianapolis, IN under 510 K: K960023. The boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "E-Z Frame Surgical Boot," submitted to the FDA in 2005. It is a traditional submission for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the questions related to AI/software performance, such as acceptance criteria, study design for performance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable here.

The document primarily describes the device's components, its intended use, and its substantial equivalence to a predicate device. The FDA's letter confirms the clearance based on substantial equivalence to pre-amendment devices or previously cleared devices.

Here's an attempt to address the questions based on the provided text, indicating where information is not applicable:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this type of device. For a traditional medical device like a surgical boot, acceptance is typically based on mechanical integrity, biocompatibility of materials, and successful comparison to a predicate device's intended use and safety profile.
Reported Device Performance:
- Manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post-surgical conditions.
- Stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully.
- Employs lightweight materials: 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate, and small ASTM F 17-4 Stainless Steel Fixtures.
- Foot stabilized to the distal ring using Kirshner Wires (K-Wire) (predicate K960023).
- Boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

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

Not applicable. This is a physical device submission, not a study of algorithm performance on a test set of data. The "test" in this context refers to general mechanical and material quality and safety validations, not data-driven performance.

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. Ground truth for a dataset is not relevant to this type of device submission. The "ground truth" for the device itself would be its ability to physically stabilize the foot as intended and its safety through material and design evaluation, usually performed by engineers and regulatory bodies.

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

Not applicable. No adjudication method for a test set of data.

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 is not an AI/software device.

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

Not applicable. This is not an AI/software algorithm.

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

Not applicable for an AI data-driven context. For this device, the "ground truth" for its performance is its physical stability, material compatibility, and engineering design meeting specified standards for orthopaedic devices, which is evaluated through engineering tests and comparison to predicate devices, not data-based ground truth.

8. The sample size for the training set

Not applicable. There is no training set for an AI/software model.

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

Not applicable. There is no training set for an AI/software model.

Summary

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K 043289

FEB 1 1 2005

510K SUMMARY OF SAFETY AND EFFECTIVENESS

Indications for Use:

1. Triple arthrodesis
1. Isolated rearfoot arthrodesis
1. Midfoot arthrodesis
1. Comminuted trauma
1. Diabetic Charcot reconstruction
1. Most foot pathology not requiring fixation above the ankle

Contact Information:

If further information is required, please contact Dr. Louis A. Serafin, Jr. at Signal Medical Corporation, 400 Pyramid Drive, Marysville, MI 48040. Phone 810-364-7070.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Louis A Serafin, Jr., MD Signal Medical Corporation 400 Pyramid Dive Marysville, Florida

Re: K043289 Trade/Device Name: E Z Frame Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 31, 2005 Received: February 1, 2005

Dear Dr. Serafin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (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.

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Page 2 - Louis A. Serafin, Jr., MD

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mikkelsen

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page	of
------	----

5 10(K) Number (If known): _______________

E Z Frame Device Mame:

Indications For Use:

Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis Comminuted trauma Comminated a reconstruction Diabetic Charcot reconscraction
Most foot pathology not requiring fixation above the ankle

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE
ON ANOTHER PAGE IF NEEDED)

Concurrence of
(ODE)
Office of Device Evaluation
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K043289
Prescription Use	X
Counter Use
(Per 21 CFR 801.109)

OR Over-The-

(Optional Format

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.