(29 days)
The EBI® DynaFix® Diaphyseal Correction System is a unilateral external fixation device 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® DynaFix® Diaphyseal Correction System is a module which is used in conjunction with the currently marketed EBI XFIX DFS System. The EBI DynaFix Diaphyseal Correction System has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The 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 System is attached to the shanks of the bone screws.
The provided text describes the 510(k) summary for the EBI® DynaFix® Diaphyseal Correction System. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a study presenting performance data against acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it is generally not part of a 510(k) summary focused on demonstrating substantial equivalence.
Here's what can be inferred or directly stated from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, which implies the new device performs as intended and is as safe and effective as the predicate.
- Reported Device Performance: The document states, "There are no significant differences between the EBI® DynaFix® Diaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function." This is a qualitative statement of equivalence rather than specific performance data against a set of quantitative criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This document does not describe a clinical or performance study with a test set.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process 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. This device is an external fixation system, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for a study is mentioned. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what is known from the provided text:
- Device Name: EBI® DynaFix® Diaphyseal Correction System
- Intended Use: 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.
- Regulatory Pathway: 510(k) Premarket Notification.
- Claim of Equivalence: The device is claimed to be substantially equivalent to the predicate device (EBI® XFIX® DFS® System K953406, K000319) in terms of intended use, materials, and function.
- Materials: Titanium, stainless steel, aluminum, and Delrin®.
- FDA Decision: FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
§ 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.