(29 days)
The Hoffmann LRF System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
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. The system components are manufactured from 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 from the FDA regarding the Hoffmann LRF System. It states that the device is substantially equivalent to a previously marketed predicate device (K203568).
The crucial information for addressing your request, particularly regarding acceptance criteria and performance studies, is explicitly absent.
Here's why and what can be inferred:
- No Acceptance Criteria or Performance Data Presented: The document states under "Performance Data":
- "Non-Clinical Testing: No performance testing is necessary to support the claim of substantial equivalence."
- "Clinical Testing: No clinical testing is necessary to support the claim of substantial equivalence."
This means that for this specific 510(k) submission (K233741), the FDA's clearance was based on the device's substantial equivalence to a predicate device (K203568), rather than requiring new, specific performance study data or predefined acceptance criteria to be met for this submission. The change from the predicate device is noted as a "dimensional change to the struts."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not provided in the supplied text. The FDA's decision was based on a comparison to an already cleared device, implying that the performance and safety characteristics were considered to be sufficiently similar, and no new studies were deemed necessary for this particular submission.
In summary, based only on the provided text, the answer to all your specific questions regarding acceptance criteria and study details is that this information is not available within this 510(k) submission document.
§ 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.