(119 days)
This device is indicated for use in the fixation of unstable femoral neck fractures.
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures is an implantable device to be used in orthopedic trauma procedures. The D.S.S. System For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most flexibility in configurations of osteosynthesis in unstable femoral neck fractures.
This document is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures. As such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process primarily relies on non-clinical data (e.g., mechanical testing, materials characterization) and comparison to legally marketed predicate devices to establish safety and effectiveness.
Here's a breakdown of why this information isn't present in this type of submission:
- Acceptance Criteria & Performance Data: 510(k) submissions typically do not include detailed performance tables from clinical trials with specific acceptance criteria like sensitivity, specificity, or AI-assisted improvement. Instead, they focus on showing that the new device performs as intended and is as safe and effective as a predicate device.
- Clinical Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone): These are elements of a clinical trial designed to assess device performance in human subjects. A 510(k) summary usually relies on bench testing and comparisons to predicate devices, especially for devices like orthopedic implants, where clinical studies may not be required for market clearance if substantial equivalence can be established otherwise.
- Ground Truth: The concept of "ground truth" (e.g., expert consensus, pathology) for clinical performance is not typically a primary focus of a 510(k) submission for orthopedic implants unless a specific clinical study was conducted (which isn't detailed here).
- Training Set Information: This is relevant for AI/ML devices. The Fixano DSS system is a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device. Thus, there is no AI training set.
Summary of available information related to performance/equivalence from the document:
- Intended Use: Fixation and osteosynthesis of unstable femoral neck fractures.
- Technological Characteristics: Hip screw mechanism allowing natural, weight-bearing compression. Can be used alone or with a mini-plate for flexibility in osteosynthesis configurations.
- Substantial Equivalence: Claims substantial equivalence to various existing hip screw systems, including Synthes Sliding Screws (K954757), Dynamic Hip Screw (DHS) (K791619), and Howmedica Plus Compression Hip Screw System Omega (K955306). This implies that the device performs similarly in its intended function to these predicate devices, which are already on the market.
In conclusion, this 510(k) summary does not contain the detailed clinical study information requested because it is a premarket notification for an orthopedic implant seeking clearance based on substantial equivalence, rather than a clinical trial report for an AI-enabled device or a device requiring new clinical performance data.
§ 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.