(29 days)
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.
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).
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.
§ 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.