External fixation components are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Device Description

External skeletal fixator systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins, may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, or other means of internal fixation. External fixator elements consist of components such as straight and curved rods, tubes, rodto-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-torod, and ring-to-pin clamps.

Vanguard receives previously used external fixation devices from healthcare facilities. These devices are cleaned, inspected, tested, repackaged and returned to the healthcare facility.

AI/ML Overview

It is important to note that the provided text is a 510(k) Summary of Safety & Effectiveness for reprocessed external fixation devices, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (like ground truth establishment for training, MRMC studies, effect size of human improvement with AI, standalone performance of an algorithm) are not directly applicable.

However, I can extract the relevant information regarding the general device, its acceptance criteria, and the study proving it meets those criteria based on the provided document.

Here's the analysis of the acceptance criteria and the study for the Vanguard Reprocessed External Fixation Devices:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (as stated or implied)
Material & Physical Properties	Not explicitly stated as numerical criteria, but implied equivalence to OEM.	Reprocessed devices are "essentially identical to the currently marketed OEM devices." No changes are made to the currently marketed device's specifications, and they possess the same technological characteristics.
Functional Performance	Not explicitly stated as numerical criteria, but implied equivalent function to OEM.	"Performance/functional testing demonstrates the devices are equivalent and continue to be safe and effective for their intended use."
Sterilization	Adequate sterilization to ensure safety.	"Sterilization validations demonstrate that the reprocessed devices perform as intended and are safe and effective."
Packaging	Appropriate packaging to maintain sterility and device integrity.	"Packaging validations demonstrate that the reprocessed devices perform as intended and are safe and effective."
Safety and Effectiveness	Devices are safe and effective for their intended use.	"Performance, sterilization and packaging validations demonstrate that the reprocessed devices perform as intended and are safe and effective." Concluded "substantially equivalent to the predicate devices."

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

Sample Size: The document does not specify the exact sample size for the "performance, sterilization and packaging validations." It generically refers to "reprocessed devices."
Data Provenance: The devices are "previously used external fixation devices from healthcare facilities." This implies the data/devices for testing are retrospective (they were used previously) and likely originate from healthcare facilities within the United States (given the FDA submission).

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

This question is not applicable as this is a medical device reprocessing submission, not an AI/ML diagnostic device. Ground truth, in the context of AI/ML, refers to a definitively correct diagnosis or measurement. For this device, "ground truth" would be the established performance and safety of the original (OEM) devices, and the study aims to show equivalence of the reprocessed devices. The document does not describe the use of experts to establish a "ground truth" in this AI/ML sense.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts establishing ground truth or evaluating performance. This document describes engineering and validation testing of a reprocessed physical device, not an interpretative task requiring multi-reader adjudication.

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 question is not applicable. An MRMC study is relevant for diagnostic or interpretive AI systems where human readers' performance with and without AI assistance is compared. This submission pertains to physical medical devices, not an AI system.

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

This question is not applicable. This refers to the standalone performance of an AI algorithm, which is not what this submission is about.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is effectively the established safety and performance profile of the original equipment manufacturer (OEM) devices. The study aims to demonstrate that the reprocessed devices maintain that same safety and performance, making them "substantially equivalent." There isn't a "ground truth" established from pathology or outcomes data specifically for the reprocessed devices in this submission in the way it would be for a diagnostic tool.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI/ML model. This document describes the re-processing and testing of physical medical devices, not the development of an AI algorithm.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as above. There is no AI/ML training set mentioned or implied in this submission.

Summary

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APR	30
	2004

031687
page 1 of 3

510(k) Summary of Safety & Effectiveness

Submitter	Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815
Contact	Heather Crawford, RACDirector of Regulatory Affairs(863) 683-8680, extension 249(863) 683-8703 (facsimile)hcrawford@safe-reuse.com
Date	May 30, 2003
Device	Trade Names: Vanguard Reprocessed External Fixation Devices ⇒ Stryker® Trauma External Fixation Devices⇒ Synthes® (USA) External Fixation DevicesCommon Name: External fixation devicesClassification: 21 CFR 888.3030 – Single/multiple component metallic bone fixation appliances and accessories – Class IIProduct Code KTT
PredicateDevices	Respective Stryker® Trauma and Synthes® legally marketed external fixation devices under various 510(k) premarket notifications.
Indications forUse	External fixation components are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.
Contra-indications	External fixation systems are contraindicated in patients with mental or neurologic impairment that would interfere with cooperative postoperative care.These devices are not intended for attachment or fixation of screws to the spine. Continued on next page

Hoffmann®, Compact™, and Tenxor™ are registered trademarks of Stryker® Trauma, a division of the Stryker Corporation
Synthes® is a registered trademark of Synthes-Stratec.

v - Page 1 of 4

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External skeletal fixator systems are comprised of various elements that, Device Description when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins, may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, or other means of internal fixation. External fixator elements consist of components such as straight and curved rods, tubes, rodto-rod, and rod-to-pin couplings and clamps, rings and ring segments, ring-torod, and ring-to-pin clamps.

Rods and Tubes ~ Straight rods and tubes are unilateral external fixation devices of varying lengths and diameters that are used with rod-to rod and pin-to-rod clamps by the surgeon to connect anchoring pins, screws and wires together to form a rigid structure that immobilizes the affected bone or structures. Differences in length and diameter of the rods or tubes allow accommodation of a broad range of fracture scenarios and applied loads. All rods have a straight, solid, round design. Tubes are normally larger diameter than rods, and are therefore typically lighter than a solid rod of the same material and diameter, while retaining similar load bearing capabilities to a solid rod of equal diameter. Rods and tubes are typically constructed of either stainless steel, carbon fiber, or aluminum.

Curved rods are multilateral devices bent in shapes useful for some constructs where straight rods are less suitable. These rods allow the surgeon to connect pins in various locations in the limb together to form a rigid structure. Curved rods are manufactured from either aluminum or stainless steel.

Rod-to-Rod Couplings or Clamps ~ These are multi-element components used to connect one rod or tube to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods or tubes. The devices are typically constructed from one of the following materials: anodized aluminum alloys, steel or stainless steel alloys and titanium alloys.

Rod or Tube-to-Pin Couplings or Clamps ~ These are multi-element components used to connect one rod or tube to a pin or group of pins in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods or tubes to

Continued on next page

Hotimann®, Compact™, and Tenxor1M are registered trademarks of Stryker® Trauma, a division of the Stryker Corporation. Synthes® is a registered trademark of Synthes-Stratec.

v - Page 2 of 4

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Device Description, continued

specific sizes or ranges of sizes of pins. The devices are typically constructed from one or more of the following materials: Anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Rings and Ring Segments ~ These are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of bones. Tensioned wires or pins are commonly attached to rings and ring segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.

Ring-to-Rod Clamps ~ Ring-to-rod clamps are utilized to connect a ring or ring segment to a rod. These attachments are made to form an external fixator frame construct as required for the particular biomechanical needs of the procedure. Ring to rod clamps are typically constructed from one or more of the following materials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or wire clamps are utilized to connect an external fixation ring or ring segment to a pin or wire that is normally affixed to the bone passing centrally through the ring. Wires are normally attached on one side of the ring, passed through the bone, and continue to an attachment point on the opposite side of the ring where they are affixed under tension to another ring to wire clamp. Ring-to-pin clamps are used to secure the ring to a pin or set of pins that are anchored in the bone passing centrally through the external fixation ring. Ring-to-pin and ring-towire clamps are typically constructed from one or more of the following materials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Continued on next page

Hoffmann®, Compact™, and Tenxor™ are registered trademarks of Stryker® Trauma, a division of the Stryker Corporation. Synthes 8) is a registered trademark of Synthes-Stratec.

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510(k) Summary of Safety & Effectiveness, Continued

DeviceDescription,continued	Vanguard receives previously used external fixation devices from healthcarefacilities. These devices are cleaned, inspected, tested, repackaged andreturned to the healthcare facility.
TechnologicalCharacteristics	The Vanguard reprocessed external fixation devices are essentially identical tothe currently marketed OEM devices. No changes are made to the currentlymarketed device's specifications and they possess the same technologicalcharacteristics. Performance/functional testing demonstrates the devices areequivalent and continue to be safe and effective for their intended use.
Test Data	Performance, sterilization and packaging validations demonstrate that thereprocessed devices perform as intended and are safe and effective.
Conclusion	Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed external fixation devices are substantially equivalent to thepredicate devices under the Federal Food, Drug and Cosmetic Act.

Hoffmann®, Compact™, and Tenxor™ are registered trademarks of Stryker® Trauma, a division of the Stryker Corporation. Synthes® is a registered trademark of Synthes-Stratec.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wings or feathers. The eagle's head is facing left, and its body is composed of curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Ms. Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815

Re: K031687

Trade/Device Name: Vanguard Reprocessed External Fixation Devices 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 30, 2004 Received: February 2, 2004

Dear Ms. Crawford:

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 - Ms. Heather Crawford, RAC

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millerson

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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Indications for Use

510(k) Number: K03 687

Device Name: Vanguard Reprocessed External Fixation Devices

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Mark M. Melleur. iv
Division Sign-Off

Division of General, Restorative, and Neurological Devices

687 510(k) Number

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.