The MDPO Frame System is indicated for use in the lower extremity for: open and closed long bone fracture fixation, to include tensioned wire fixation of periarticular fractures, arthrodesis, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities, dislocations, arthrodiastasis, and Charcot foot reconstruction and Lisfranc dislocations.

Device Description

The MDPO Frame System is an external fixation system that can be made into various configurations for lower limb application. The MDPO Frame System includes the following components: Half Pins, Wires, Footplate consisting of the Connecting Plate/Assembly with interchanging Medial and Lateral Arch Plates/Assemblies, Matching Rings, Open Rings, Closed Circular Rings, Columns, Threaded Rods, Sockets, Screws, Bolts, Nuts, Washers, Posts, and Cubes. The components of the MDPO Frame System are made from stainless steel, carbon fiber, Radel or aluminum. All components are designed for single use only.

AI/ML Overview

This request pertains to the MDPO Frame System (K093753), an external fixation system for lower limb application.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it describes a comparative study to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of being "at least equivalent."

Acceptance Criteria (Implied)	Reported Device Performance
Construct Fatigue Strength: At least equivalent to the Ilizarov External Fixation System.	The MDPO Frame System was at least equivalent in strength to the Ilizarov External Fixation System in construct fatigue testing.
In-plane Compression Strength of Simple Bridge Ring Elements: At least equivalent to the Ilizarov External Fixation System.	The MDPO Frame System was at least equivalent to the Ilizarov External Fixation System in in-plane compression strength testing.
Material Equivalence (Radel Columns vs. Stainless Steel Rods): Substantially equivalent to Ilizarov stainless steel rods.	Construct fatigue testing confirmed that the Radel Columns are substantially equivalent to the Ilizarov stainless steel rods.

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

The document does not specify the sample size used for the construct fatigue testing or in-plane compression strength testing.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, as a 510(k) summary, the testing would generally be conducted by the manufacturer or a contracted lab to meet regulatory requirements prior to submission.

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

Not applicable. This device is a mechanical medical device, and its performance evaluation relies on engineering-based mechanical testing (fatigue, compression strength) against established ASTM standards and predicate device performance, not on expert adjudication of diagnostic images or clinical outcomes that would require ground truth established by medical experts.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. The evaluation is based on objective mechanical stress and strain measurements, not subjective interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. This is a mechanical device, and its safety and effectiveness were demonstrated through mechanical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a mechanical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device is the measured mechanical properties (e.g., fatigue life, compression strength) obtained through standardized engineering tests, and their comparison to established benchmarks (e.g., ASTM standards, predicate device performance for equivalency).

8. The Sample Size for the Training Set:

Not applicable. This is a mechanical device. There is no concept of a "training set" as it would apply to machine learning algorithms. Design and material selection for external fixation systems are based on engineering principles and material science, not a data-driven training process.

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

Not applicable. See point 8.

Summary

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MDPO Frame System 510(k) Summary K093753

Device Manufacturer:	MDPO LLC1560 Sawgrass Corporate PkwySuite 400Sunrise, FL 33323
Primary Contact:	Marcos Velez-DuranM Squared Associates, Inc.Tel: 703-562-9800, Ext 206Fax: 703-562-9797Email: mvelez-duran@msquaredassociates.com
Proprietary Name:	MDPO Frame System
Classification Name:	888.3030 Single/multiple component metallic bone fixationappliances and accessories
Common Name:	External Fixation Frame Components
Device Class:	Class II
Product Codes:	KTT and JDW
	AUG 26 2010

Device Description and Intended Use:

The components of the MDPO Frame System are made from stainless steel, carbon fiber, Radel or aluminum.

All components are designed for single use only.

: "

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MDPO Frame System 510(k) Summary K093753

Predicate Devices:

The MDPO Frame System is similar to several predicates including the following:

Smith & Nephew Ilizarov External Fixation System (K870961, K962808, K994143) .
DePuy ACE-Fischer External Fixation System (K083789) .
. Biomet Vision FootRing System (K071395, K093057)

Technological Characteristics

The MDPO Frame System was characterized and evaluated according applicable requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. Specifically, construct fatigue testing and inplane compression strength testing were conducted. Construct fatigue testing was conducted on the MDPO Frame System and the Ilizarov External Fixation System and it was determined that the MDPO Frame System was at least equivalent in strength to the Ilizarov External Fixation System. In-plane compression strength testing of the simple bridge ring elements was also conducted on both the MDPO Frame System and the Ilizarov External Fixation System. The strength testing also confirmed that the MDPO Frame System is at least equivalent to the Ilizarov External Fixation System.

Substantial Equivalence Information:

The MDPO Frame System is similar to legally marketed devices including the Smith & Nephew Ilizarov External Fixation System, DePuy ACE-Fischer External Fixation System, and the Biomet Vision FootRing System. The MDPO Frame System has similar indications for use and technological characteristics as these predicate systems. While MDPO Frame System includes stainless steel Rods and Radel Columns and the predicate systems utilize stainless steel rods, construct fatigue testing confirmed that the Radel Columns are substantially equivalent to the Ilizarov stainless steel rods. Therefore, the MDPO Frame System is determined to be substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MDPO, LLC % M Squared Associates, Inc. Mr. Marcos Velez-Duran 901 King Street, Suite 200 Alexandria, Virginia 22314

AUG 26 2010

Re: K093753

Trade/Device Name: MDPO Frame System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW

Dated: July 12, 2010 Received: July 13, 2010

Dear Mr. Velez-Duran:

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

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Page 2 - Mr. Marcos Velez-Duran

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbara Buehns

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

Enclosure

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Indications for Use Statement

K098753

510(k) Number: K093753

Device Name: MDPO Frame System

Indications for Use:

AND/OR Prescription Use X --------(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign OA) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093753

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.