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The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

The PRECICE Trauma Nail System is composed of the PRECICE Trauma Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC or ERC 2P). The Nail is available in various diameters, lengths and screw-hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Trauma Nail is supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model) to allow for compression fracture reduction techniques.

This document is a 510(k) premarket notification for the "PRECICE Trauma Nail System" and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/medical device.

Therefore, the requested information (1-9) about acceptance criteria and study results cannot be extracted from this document, as it describes a clearance process for a medical device rather than a comprehensive performance study that would typically include such details.

Specifically:

• No acceptance criteria or device performance table is provided. The document states "Non-clinical testing of the PRECICE Trauma Nail System included design verification testing to ensure the device meets the retraction (compression) force and distraction force required for the humerus and cadaveric design validation testing to ensure the device can be inserted into the medullary canal and fixed to the humerus using the humeral specific instruments." This describes the types of tests performed, but not specific numerical acceptance criteria or the reported performance.
• No information on sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, or how ground truth for the training set was established is present. These details are typically found in clinical validation studies for diagnostic or AI-driven devices, which this is not.

The document primarily focuses on:

• Indications for Use: "The Ellipse PRECICE Trauma Nail System is indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones."
• Substantial Equivalence: The device is deemed substantially equivalent to the "PRECICE® Trauma Nail System" (K142599) based on "same indications for use, technological characteristics, principles of operation, designs, and on in vitro testing performed."
• Technological Characteristics: The device is described as a titanium intramedullary nail with a telescoping portion, an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing, adjusted non-invasively by an External Remote Controller (ERC).
• Non-clinical Testing: Mechanical testing (according to ASTM F1264-03), gamma radiation sterilization cycle validation (ISO 11137-2), shelf life testing, O-ring seal performance, and biocompatibility (ISO 10993-1) were performed on the predicate device and found applicable. Design verification and cadaveric design validation specific to the humeral models were also conducted for the current submission.

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