(26 days)
The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The EBI® XFIX® Access™ Pelvic Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic Fixator is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI® XFIX® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.
This 510(k) summary describes a device, the EBI® XFIX® Access™ Pelvic Fixator, which is a physical medical device and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes (carbon fiber bar replacing a titanium bar). Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth, which are typically relevant for AI/ML device evaluations, are not applicable to this submission.
The closest information provided related to device performance is a general statement about compliance with applicable standards and meeting all functional requirements for the modified device.
Here's a breakdown of why each requested point is not present in the provided document, given the nature of the device:
- A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or quantitative performance metrics typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). The submission's focus is on material equivalence and functional equivalence for a physical fixator.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm for this physical device. The testing likely involved mechanical and material performance tests, not data analysis on patient cases.
- 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. There is no ground truth, expert consensus, or clinical data analysis in the manner expected for AI/ML.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
- 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. This is not an AI-assisted diagnostic or decision-support device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The information in this 510(k) pertains to a physical medical device (an external fixator) and not an AI/ML algorithm. As such, the specific criteria and study details requested (which are typical for AI/ML device evaluations) are not present in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that a material change (carbon fiber bar) maintains the device's intended use and functional requirements.
§ 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.