(14 days)
The EBI® XFIX® DFS® System is 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 System consists of external fixation components and implantable bone screws. The EBI XFIX DFS System 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 DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a Gradual Swivel Clamp to the System.
This submission is for a modification to an existing external fixation system, not a device that relies on AI or complex algorithms for performance. Therefore, the provided text does not contain any information about acceptance criteria or a study proving a device meets those criteria in the context of AI/algorithm performance.
The document is a 510(k) summary for a medical device (EBI® XFIX® DFS® System) that discusses:
- Sponsor and Contact Information
- Proprietary and Common Names
- Classification
- Predicate Device: EBI® XFIX® DFS® System (K953406)
- Device Description: The system consists of external fixation components and implantable bone screws. The submission is only for the addition of a Gradual Swivel Clamp.
- Intended Use: Treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by external fixation.
- Materials: Aluminum, stainless steel, and titanium alloy.
- Comparison to Predicate: The modified device is stated to be "substantially equivalent" to the predicate device in terms of materials, intended use, and function, with no significant differences. The added component (Gradual Swivel Clamp) is also non-sterile, like other components.
- FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.
To directly answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. This document is for a mechanical device modification, not a performance-based algorithm or AI system. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence to a predicate device, which is stated as having been met.
- 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 mention of a test set, data, or a clinical study for performance evaluation in the context of an algorithm. The assessment is based on mechanical and material equivalence.
- 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. No experts were used for ground truth establishment for a test set as described in the context of AI/algorithm evaluation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no test set or adjudication for an algorithm.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's equivalence is being assessed.
- The sample size for the training set: Not applicable. There is no training set mentioned for an algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a 510(k) submission for a minor modification to an existing mechanical external fixation system. It relies on a demonstration of "substantial equivalence" to a predicate device rather than performance criteria derived from a study involving algorithms, data, or expert evaluation as you've outlined in your questions.
§ 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.