Search Results

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

The Synthes EIN system consists of flexible intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is manufactured from Titanium Alloy.

This document describes a 510(k) premarket notification for a medical device called the Synthes Elastic Intramedullary Nail (EIN) System (Line Extension). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Here's why and what's typically found in a K-submission for devices like this:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness.
• Performance Data for Well-Established Device Types: For devices like intramedullary fixation rods, which are well-established, the FDA typically relies on recognized standards (e.g., ASTM standards for mechanical testing of implants), prior predicate devices with a history of safe and effective use, and sometimes bench testing to show the new device meets those standards or is comparable to the predicate. Clinical studies with detailed performance metrics and acceptance criteria for algorithm performance are common for novel software devices or AI/ML-driven diagnostics, but not typically for a line extension of a mechanical implant unless a new indication or a significant change in design warrants it.

Based on the provided text, I cannot provide the requested information because it is not present. The document focuses on:

• Device Name: Synthes Elastic Intramedullary Nail (EIN) System (Line Extension)
• Classification: Intramedullary fixation rod (21 CFR 888.3020)
• Predicate Devices: Synthes Elastic Intramedullary Nail (EIN) System, Depuy Ace Nancy Nail
• Device Description: Flexible intramedullary fixation devices of varying diameters and lengths, cut to size intraoperatively, curved tapered tip, manufactured from Titanium Alloy.
• Intended Use: Fixation of diaphyseal fractures (narrow canal or high flexibility needed), upper extremity fractures in all patients, lower extremity fractures in pediatric or small-stature patients, metaphyseal/epiphyseal fractures (e.g., radial neck), and small long bones (e.g., carpal, tarsal). Emphasizes avoiding disruption to the bone growth plate in pediatric applications.
• Substantial Equivalence: States that comparative information supports substantial equivalence to the predicate devices.

What would be expected in a typical K-submission for a mechanical implant to demonstrate substantial equivalence (even if not explicitly detailed here):

• Bench Testing: Mechanical testing (e.g., bending strength, torsional strength, fatigue testing) according to relevant ASTM or ISO standards to show the new device performs at least as well as the predicate and meets established safety margins.
• Biocompatibility: Testing to ensure the material (Titanium Alloy) is biocompatible.
• Sterilization Validation: Data to show the sterilization process is effective.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study data, sample sizes, experts, adjudication, MRMC, or standalone performance for an AI model because this product is a physical medical device (an intramedullary nail), not an AI/software device, and the provided document is a 510(k) summary, which doesn't typically delve into such granular study details for device line extensions.

Ask a specific question about this device