(362 days)
The Smith & Nephew Circular Fixation system is intended to be 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 .
- Correction of bony or soft tissue deformities ●
- Correction of bony or soft tissue defects .
- Joint arthrodesis ●
- Infected fractures or nonunions .
Components in the Smith & Nephew Circular Fixation System are for single use only.
Subject of this Traditional 510(k) premarket notification is the Smith & Nephew Circular Fixation System. The subject device is a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. The Circular Fixation system can also be used with a software component that is designed to be used to assist the physician in adjusting the six struts by creating a patient adjustment schedule. Components of this premarket notification include the following:
- Full, half, 2/3 and foot rings manufactured from aluminum material. .
- . U-plates manufactured from aluminum material.
- Adjustable struts manufactured from aluminum material .
- . Drill tip wires manufactured from stainless steel material
- Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
- . Disc clips manufactured from polycarbonate material
- Half pin caps manufactured from PVC material
- . Web-based software
The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.
The Smith & Nephew Circular Fixation System is a medical device designed for external fixation of bones, primarily for fracture fixation, joint fusions, and limb lengthening/deformity corrections. The device includes hardware components (rings, plates, struts, wires, accessories) and a web-based software component to assist physicians in adjusting the struts.
The provided document describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain a study comparing the device's performance against specific acceptance criteria in the format requested. Instead, it focuses on the engineering and software validation aspects to support its "substantial equivalence" claim for 510(k) clearance.
Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information provided, we can infer some details regarding the device's validation.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance Statement |
|---|---|---|
| Mechanical Performance | Ability of hardware components to withstand expected in vivo loading without failure. Includes: |
- Drill Tip Wires: Adequate cutting performance.
- Pin Connector Hinge and Post: Ability to withstand maximum tightening torque.
- Pin Connector Assembly: Adequate mechanical integrity.
- Combo Wire Fixation Bolt: Adequate wire pull-out force and maximum threading torque.
- ControlFx Strut: Adequate mechanical evaluation. | "A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure."
Specific tests performed:
- Cutting Performance Evaluation of Drill Tip Wires
- Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin Connector Post
- Mechanical Evaluation of the Pin Connector Assembly
- Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt
- Mechanical Evaluation of the ControlFx Strut
"A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
| Software Performance | Software to perform as intended, specifically in assisting the physician in adjusting the six struts by creating a patient adjustment schedule. Adherence to FDA's guidance document "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. This implies criteria for:
- Installation Qualification (IQ): Correct installation and configuration.
- Operational Qualification (OQ): Operation according to specifications.
- Performance Qualification (PQ): Consistent performance under anticipated conditions. | "software verification and validation testing was completed in line with FDA's guidance document entitled, 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff,' dated January 11, 2002. The results of the testing indicate that the software will perform as intended."
Specific tests performed:
- Software Installation Qualification Protocol
- Software Operational Qualification Protocol
- Software Performance Qualification Protocol
"A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document refers to "mechanical data" and "software verification and validation testing." For mechanical tests, the sample size would typically refer to the number of components tested for each specific evaluation (e.g., number of wires, pins, struts). For software, it would relate to the test cases executed. These specific numbers are not provided.
- Data Provenance: The nature of the tests (mechanical and software validation) indicates the data would be laboratory-generated rather than clinical patient data. Therefore, "country of origin" of data is not applicable in the clinical sense. The testing was conducted by Smith & Nephew, Inc. (USA) and evaluated by the FDA (USA). The study is not clinical and therefore not retrospective or prospective in the typical medical device context.
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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 for this type of submission. This submission is for hardware and software validation, not for diagnostic or predictive AI with a clinical ground truth. The "ground truth" would be established by engineering specifications and correct software functionality as defined by its design and intended output. Expertise would be in materials science, mechanical engineering, and software engineering/validation rather than clinical diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human readers assess cases. This document focuses on direct mechanical and software function testing. The "adjudication" for mechanical tests would be acceptance/rejection based on meeting predefined engineering thresholds. For software, it's about whether the software functions according to its validated protocols.
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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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." The software component assists the physician but its performance was validated as a standalone component, not in a human-AI team context described by MRMC.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance evaluation was done for the software. The document mentions "software verification and validation testing," including "Software Installation Qualification Protocol," "Software Operational Qualification Protocol," and "Software Performance Qualification Protocol." These are standard procedures to ensure the software itself (the "algorithm only") functions correctly according to its specifications, independent of human interaction during the test process. Its purpose is to assist a human, but the validation described here is for the software's functional correctness.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Mechanical Performance: The ground truth is generally based on engineering specifications, material properties, and established biomechanical standards for bone fixation devices. The tests verify that components withstand defined forces, torques, and perform cutting as expected.
- For Software Performance: The ground truth is defined by the software's functional specifications and design documentation. The validation protocols (IQ, OQ, PQ) verify that the software delivers the expected outputs and performs its intended calculations accurately according to its design.
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The sample size for the training set:
- Not applicable. The software component described here is likely rule-based or algorithmic for adjustment schedules, rather than a machine learning/AI model that requires a distinct "training set." If there were configurable parameters or specific calculations, these would be based on engineering principles and validated through the performance qualification, not "trained" on data samples.
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How the ground truth for the training set was established:
- Not applicable. As a non-ML/AI component in the sense of predictive models, there is no "training set" or corresponding ground truth for training. The software's "ground truth" is its deterministic mathematical and logical function in calculating adjustment schedules, which is verified through testing against expected outcomes for given inputs.
§ 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.