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The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius
• Bone transport

The Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient and utilizes stainless steel, aluminum, PEEK, and carbon fiber.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

This document is a 510(k) premarket notification for the Hoffmann LRF System, an external fixation device. It describes the device, its intended use, indications for use, and a comparison to a predicate device. However, it explicitly states:

"Clinical testing was not required to be provided for this submission."

Therefore, the document does not contain any information about a study proving the device meets acceptance criteria in the way you are asking (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/device performance studies).

The "Performance Data" section only mentions "Non-Clinical Testing" which includes:

• Corrosion Test
• Self-holding Function Test Over Time
• Pullout Test

These are mechanical tests, not clinical performance studies measuring diagnostic accuracy or treatment effectiveness in humans.

Based on the provided text, I cannot answer your questions regarding acceptance criteria and performance study details because such a study was not required or provided in this FDA submission.

The document is a regulatory approval notice for a physical medical device (an external fixation system), not a software or AI-driven diagnostic device that would typically involve the types of performance studies you are inquiring about (e.g., those requiring expert review, ground truth establishment, or human-in-the-loop performance measurements).

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