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Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to 16mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. The Lorenz Sternal Closure System will be marketed as non-sterile, single use devices.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or details about ground truth establishment. The document is a 510(k) summary for the Lorenz Sternal Closure System, primarily focusing on its intended use, description, materials, sterility, and substantial equivalence to previously cleared devices. It also lists possible risks associated with the device.

Therefore, I cannot fulfill your request for the table and study details based on the given input.

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Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to I the Lorental Storal Clobal v Systems so that a preditled hole is not required, but may be used.

This document is a 510(k) premarket notification for the "Lorenz Sternal Closure System," which is a metallic bone fixation appliance. The FDA determination is that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any multi-reader multi-case (MRMC) or standalone studies.

The document primarily focuses on:

• Device Name: Lorenz Sternal Closure System
• Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030), Class II.
• Intended Use: Stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
• Description: 2.4 mm self-drilling screws with variable lengths.
• Sterility: Marketed as non-sterile, single-use, with steam sterilization recommendations for hospitals.
• Substantial Equivalence: Claimed to be equivalent to Lorenz 2.4 Self Drilling Screw (K03228) and Lorenz Sternal Closure System (K011076).
• Possible Risks: Lists several potential complications associated with implants and surgical procedures.
• FDA Clearance: A letter from the FDA confirming substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested table or details about acceptance criteria and study results because this information is not present in the provided text.

If this were a document about a software device or an AI/ML product, it would typically include a dedicated section for performance data, acceptance criteria, and study methodologies to demonstrate clinical efficacy and safety. For a physical implantable device like this, substantial equivalence is often established through material testing, mechanical performance testing (not detailed here), and comparison to predicate devices, rather than clinical studies with human readers or AI performance metrics.

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Ask a specific question about this device