External fixation devices are used on adults or pediatric patients as required. External fixation systems consist of various components that are used to build fixator assemblies unique to the patient's need. These devices are modular, therefore, a multitude of different fixator frame configurations are possible. External fixation devices are used for the following indications:

Post-Traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudoarthrosis of long bones
Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X™ Fixator)
Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
Correction of segmental bony or soft tissue defects
Joint arthrodesis
Infected fractures or nonunions
Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius.
Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia.

The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew. The indications for the Ilizarov Pulley System are pseudoarthrosis of long bones, included as number 4 above. These indications are similar to the indications of the predicate devices. The device is intended for single use.

Device Description

The Ilizarov Pulley System consists of cables, pulleys and a ratchet. There are two styles of cable, with or without an eyelet on one end. The cables without an evelet are routed through the bone segment and perculaneously through the soft tissue. The cables with an eyelet are secured to the bone segment with a 3.5mm or 5.0mm diameter bone screw through the evelet. The cable is then routed percutaneously through the soft tissue. Cables are available in diameters of 1.0mm, 1.5mm and 1.8mm and a length of 1200mm. The 1.0mm cables feature an evelet on one end and the 1.5mm and 1.8mm cables are straight (without an eyelet).

The cable is routed through pulleys and connected to either a telescopic rod (predicate device) or a ratchet (new device). The telescopic rod or ratchet is attached to the external fixation half ring construct. The telescopic rod or ratchet is turned to tighten the cable and move the bone seament.

The Ilizarov Pulley System is used in conjunction with the Ilizarov External Fixation System that consists of half rings, threaded rods, bolts, nuts, washers, pin clamps, wire fixation bolts, half pins and wires. The Ilizarov Pulley System will be attached to the Ilizarov External Fixation System for the indication for use of pseudoarthrosis of long bones.

The advantages of using the Ilizarov Pulley System include the ability to use fewer half pins and wires. Fewer half pins and wires will create less soft tissue displacement and less limitation to joint movement (joint stiffness).

AI/ML Overview

Here's an analysis of the provided text regarding the Ilizarov Pulley System and its acceptance criteria, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study proving performance against efficacy acceptance criteria. Therefore, much of the requested information regarding "study that proves the device meets the acceptance criteria" will not be present in this document, as the regulatory pathway doesn't typically require such a study for substantial equivalence claims.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for substantial equivalence, specific quantitative "acceptance criteria" and "reported device performance" in the sense of a clinical trial outcome (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific range of improvement for a therapeutic one) are not typically presented. Instead, the acceptance criteria are implicitly met by demonstrating:

Same intended use: The device is for the same indication(s) as the predicate.
Similar technological characteristics: The device operates on similar principles and has similar materials and design.
No new questions of safety or effectiveness: Differences do not raise new concerns.

The performance is implicitly "accepted" if the FDA determines it is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.

Acceptance Criteria (Implied by 510(k) pathway)	Reported Device Performance / Justification
Intended Use: Device is for the same indications as predicate devices.	"The indications for the Ilizarov Pulley System are pseudoarthrosis of long bones... These indications are similar to the indications of the predicate devices." (Page 1)
Technological Characteristics: Similar materials, design, and operating principles to predicate devices.	Materials: "stainless steel cable... similar to the Smith & Nephew Orthopaedic Cable System... both cables are made of stainless steel." (Page 2) Design/Operating Principles: Uses cables, pulleys, and a ratchet for bone segment transport, which is comparable to the predicate devices using half pins, wires, telescopic rods, threaded rods, and slotted threaded rods for frame adjustment and bone segment transport. (Page 2)
Safety and Effectiveness: Differences do not raise new questions of safety or effectiveness.	"The Ilizarov Pulley System is substantially equivalent to the predicate devices. The differences between the Ilizarov Pulley System and predicate devices do not affect safety and effectiveness." (Page 2) "The advantages... include the ability to use fewer half pins and wires. Fewer half pins and wires will create less soft tissue displacement and less limitation to joint movement (joint stiffness)." (This is presented as an advantage, suggesting improved safety/patient comfort, not a new risk). (Page 2)
Predicate Device Legality: Substantially equivalent to a legally marketed predicate device.	Identified predicate devices: Smith & Nephew (formerly Richards) External Fixation System (Ilizarov) (K870961) and Smith & Nephew External Fixation System (K994143), and Smith & Nephew Orthopaedic Cable System (K87516). (Page 2) These are legally marketed devices.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided within this 510(k) summary. A 510(k) submission for substantial equivalence generally does not involve a "test set" in the sense of a clinical trial with a defined sample size for performance evaluation. The substantial equivalence is typically based on comparison of design, materials, and intended use to existing predicate devices, along with non-clinical testing (e.g., mechanical testing) to ensure properties are adequate. The document does not mention any clinical data or patient test sets specific to this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided within this 510(k) summary. As there is no described test set or clinical study requiring ground truth establishment, this information is not present. The FDA regulatory body (represented by Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices) reviewed the submission.

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

Not applicable/Not provided within this 510(k) summary. No test set or clinical study requiring adjudication is described.

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/Not provided within this 510(k) summary. This device is a mechanical external fixation system, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to "human readers improving with AI" is irrelevant and not mentioned.

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

Not applicable/Not provided within this 510(k) summary. This device is a mechanical system, not an algorithm.

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

Not applicable/Not provided within this 510(k) summary. No clinical ground truth or patient outcomes data for the specific Ilizarov Pulley System is mentioned as part of the substantial equivalence claim. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided within this 510(k) summary. As this is a mechanical device submission, not a machine learning model, there is no "training set."

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

Not applicable/Not provided within this 510(k) summary. As there is no training set mentioned, this information is not applicable.

Summary

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510(K) SUMMARY ILIZAROV PULLEY SYSTEM

K 042436

SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:

0C7 7 - 2004

Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe September 7, 2004 llizarov Pulley System External fixation system Single/multiple component metallic bone fixation appliances and accessories Class II Orthopedic/87

DEVICE CLASS: PANEL CODE:

DEVICE INFORMATION:

INTENDED USE:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudoarthrosis of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X™ Fixator)
1. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
1. Correction of segmental bony or soft tissue defects
1. Joint arthrodesis
Infected fractures or nonunions 9.
1. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius.
1. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia.

DEVICE DESCRIPTION:

The cable is routed through pulleys and connected to either a telescopic rod (predicate device) or a ratchet (new device). The telescopic rod or ratchet is attached to the external fixation half ring

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construct. The telescopic rod or ratchet is turned to tighten the cable and move the bone seament.

SUBSTANTIAL EQUIVALENCE INFORMATION:

The Ilizarov Pulley System is similar to the Smith & Nephew (formerly Richards) External Fixation System (Ilizarov) (K870961) and Smith & Nephew External Fixation System (K994143) in that all the devices are used for the same indications and consist of half pins, wires, rings and various components to construct an external fixation frame. The predicate devices use half pins, wires, telescopic rods, threaded rods and slotted threaded rods to adjust the external fixation frame and transport the bone segment. The Ilizarov Pulley System uses half pins, wires, cables, pulleys and a ratchet to adjust the external fixation frame and transport the bone segment.

The Ilizarov Pulley System includes a stainless steel cable. The stainless steel cable is similar to the Smith & Nephew Orthopaedic Cable System (K87516) in that both cables are made of stainless steel and the diameters are similar (1.5mm). The Ilizarov Pulley System cable is longer (1200mm) than the predicate cable (610mm). The indications for use are not the same, but the predicate cable includes indications for general orthopaedic repair procedures and any area in which monofilament wiring is used.

The Ilizarov Pulley System is substantially equivalent to the predicate devices. The differences between the lizarov Pulley System and predicate devices do not affect safety and effectiveness.

SUMMARY OF TECHNOLOGICAL COMPARISON:

The Ilizarov Pulley System is substantially equivalent to the predicate devices listed in the previous section in terms of material, indications for use and design.

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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" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0CT 7 - 2004

Mr. John Reabe Director of Regulatory Affairs Smith & Nephew Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K042436

Trade/Device Name: Illizarov Pulley System Regulation Number: 21CFR 888. 3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 7, 2004 Received: September 8, 2004

Dear: Mr. Reabe

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

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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.

This letter will allow you to begin marketing your device as described in your Section10(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/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

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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Mark A. Milken

510(k) number (if known):

Device Name: Ilizarov Pulley System

Indications for Use:

Division of General, Restorative. and Neurological Devices

510(k) Number K042436

1. Post-Traumatic joint contracture which has resulted in loss of range of motion
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudoarthrosis of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X™ Fixator)
6 Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
1. Correction of segmental bony or soft tissue defects
1. Joint arthrodesis
1. Infected fractures or nonunions
1. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius.
1. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acule transverse fractures or nonunion of the distal tibia.

The indications for use listed above cover many of the external fixation systems marketed by Smith & Nephew The astions for the extential includes and the marketed
by Smith & Nephew. The indications for the lizarov Pulley System are pseudoarthrosis of long bones, included as number 4 above. These indications are similar to the indications of the predicate devices. The device is intended for single use.

Prescription Use × (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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.