(144 days)
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.
The provided text is a 510(k) summary for the Hoffmann LRF System. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data. It explicitly states that clinical testing was not performed or required for this submission.
Therefore, I cannot provide information on acceptance criteria related to device performance in a clinical setting or a study that proves the device meets such criteria because this information is not present in the document.
The document only discusses non-clinical testing to demonstrate substantial equivalence, specifically:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of acceptance criteria for performance in the typical sense of a clinical outcome study (e.g., sensitivity, specificity for an AI device). Instead, it states that "Comparative mechanical testing to the predicate system demonstrated substantial equivalence." The tests performed were:
- Static Bending
- Dynamic Bending
- Pullout
- Corrosion
The acceptance criterion for these tests was implied to be that the subject device performs "at least as well as the predicates" based on the results of these mechanical tests and risk analyses. No specific numerical performance metrics are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as the testing was non-clinical (mechanical testing) and not performed on human subjects or clinical data sets.
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 the testing was non-clinical mechanical testing and did not involve expert review or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the testing was non-clinical 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:
This information is not applicable as this device is a mechanical external fixation system and not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop performance study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this device is a mechanical external fixation system and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device, against which the new device was compared to demonstrate substantial equivalence.
8. The sample size for the training set:
This information is not applicable as this device is a mechanical external fixation system and not an AI-based system requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as this device is a mechanical external fixation system and not an AI-based system.
§ 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.