(140 days)
The 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
Hoffmann LRF (Limb Reconstruction Frame) System is a modular, rinq-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. This system utilizes steel, aluminum, PEEK, and carbon fiber.
This submission extends K140961 by introducing a new strut and associated components. This strut can be used in all Hoffmann LRF applications that do not require the use of a foot ring, but are specifically designed for bone lengthening and bone transport. Total components added to the Hoffmann LRF System with this submission: Transport Strut, Bone Transport Strut End Cap, Safety Clip, and Lengthening Ruler, all of which are single-use, and a Tray, which is multi-use. All are provided nonsterile.
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.
The provided text is a 510(k) summary for the Hoffmann LRF System and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical mechanical testing.
Here's an breakdown of the relevant sections without the requested information:
1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes mechanical tests performed but does not list specific acceptance criteria or quantitative performance outcomes against those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Comparative mechanical testing," "component tests," and "frame construct tests." However, it does not specify the sample sizes used for these tests or the data provenance. It states "Clinical testing was not performed, or required, for this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not applicable as clinical testing was not performed, and ground truth in the context of expert consensus is not mentioned for mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as clinical ground truth establishment is not relevant to the described mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical medical device (an external fixation system), not an AI-assisted diagnostic or treatment tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the mechanical tests. For physical devices, "ground truth" would typically refer to established engineering standards or reference measurements. The document states "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate," implying a comparison to the predicate's performance.
8. The sample size for the training set: Not applicable, as this is a physical medical device and not an AI/machine learning model.
9. How the ground truth for the training set was established: Not applicable.
Summary of what is present in the document regarding performance:
- Non-Clinical Testing:
- Types of tests:
- Component tests: Static four-point bending, Dynamic four-point bending, Static cantilever bending, Dynamic cantilever bending.
- Frame construct tests: Static compression, Dynamic compression.
- Purpose: To demonstrate substantial equivalence to the Ilizarov predicate system (K031181).
- Conclusion: "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate."
- Types of tests:
- Clinical Testing: "Clinical testing was not performed, or required, for this submission."
§ 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.