(266 days)
- Bone fracture fixation
- Osteotomy
- Arthrodesis
- Correction of deformity
- Revision procedures where other devices have been unsuccessful
- Bone reconstruction procedures
The use of External Fixation devices provides surgeons with a means of bone fixation for the management of fractures and reconstructive surgery.
The Gexfix devices, in common with similar devices from other manufacturers, are intended only to assist during the healing process, and so are not intended to replace normal bone structures.
The Gexfix External Fixation devices are intended use a physical mechanism of action to hold bones in positions that aid stability during healing, thus facilitating the normal healing process. Some elements of the system are implantable during the healing process, with the main structural support being provided by external mechanical elements.
the predicate device, as cleared under K052605.
The Gexfix range includes external fixation devices for use in a variety of orthopedic applications. They are supplied non-sterile for single use, although some accessory items can be reused. Users are instructed to sterilize the components before use, using a sterilization cycle validated to achieve a sterilization Assurance Level (SAL) of at least 10-6.
The Gexfix range of external fixation devices comprises three main elements, these being:
- Invasive components
- . External components
- Ancillary components
This submission covers new components of the Gexfix system that are being added to the range of all three of the above types of component when compared with the predicate device. Some new components have an extended range of available dimensions, while other new components are additions to the range, to fulfil user needs for greater variety in the range of surgical applications, such as the introductions of components to allow external fixation of bones in the fingers, feet and shoulder.
Biocompatibility of patient-contacting materials is assured by using materials that meet applicable standards (e.g. for stainless steel and titanium alloy components) or by using materials which have received previous 510(k) clearance (e.g. PEEK).
The provided document is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Gexfix External Fixation." This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert-established ground truth, adjudication, MRMC study, standalone performance, training set details), and effect sizes cannot be directly extracted from this document, as it describes a different type of regulatory submission.
The document highlights the device's intended use for:
- Bone fracture fixation
- Osteotomy
- Arthrodesis
- Correction of deformity
- Revision procedures where other devices have been unsuccessful
- Bone reconstruction procedures
It also mentions nonclinical testing conducted based on compliance with ASTM F1541-02(2011), 'Standard Specification and Test Methods for External Skeletal Fixation Devices'. The tests included:
- Bending
- Traction
- Compression
- Sliding
- Torsion
- Pin push-out
The document states: "All tests resulted in the components being tested meeting predetermined acceptance criteria." However, it does not specify what those predetermined acceptance criteria were (e.g., specific thresholds for bending strength, torsion resistance, etc.), nor does it provide the detailed results that would form the "reported device performance" in a table. It also does not involve human readers, AI, or ground truth derived from expert consensus or pathology in the way an AI/ML device would.
The document states that the training set for the device's manufacturing (in a very broad sense, covering design and testing) would be the data and specifications from the predicate device (K052605) and current engineering standards. However, this is not a training set in the context of an AI/ML model for which the other questions are relevant.
In summary, the provided text does not contain the detailed information necessary to answer the prompt as extensively as desired for an AI/ML medical device study. It confirms that the device met "predetermined acceptance criteria" through nonclinical mechanical testing, but the specifics of those criteria and the detailed study setup (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc., typically associated with AI/ML or diagnostic device evaluations) are not present in this 510(k) summary, as it is a substantial equivalence submission for a mechanical device.
No information regarding acceptance criteria or study details for an AI/ML device (e.g., diagnostic accuracy, reader performance improvement) can be provided as this document pertains to a mechanical external fixation device.
§ 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.