(140 days)
The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
The Stryker Hoffmann LRF (Limb Reconstruction Frame) 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 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
The Stryker 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 t
- Charcot foot reconstruction ●
- Lisfranc dislocations
The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.
The provided text pertains to a 510(k) premarket notification for the Hoffmann LRF (Limb Reconstruction Frame) System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical performance studies with specific statistical acceptance criteria.
Therefore, the information requested for acceptance criteria, device performance, sample sizes used for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable (N/A) in this context, as a clinical performance study with such metrics was explicitly not required for this 510(k) submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (N/A) - Clinical performance metrics with acceptance criteria were not required as per the 510(k) submission process for this device. | Not Applicable (N/A) - Performance was evaluated based on substantial equivalence to predicate devices through non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not Applicable (N/A) - No clinical test set was used.
- Data Provenance: Not Applicable (N/A) - No clinical data was used for a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not Applicable (N/A) - No clinical test set requiring expert ground truth was performed.
- Qualifications of Experts: Not Applicable (N/A)
4. Adjudication Method for the Test Set
- Adjudication Method: Not Applicable (N/A) - No clinical test set requiring adjudication was performed.
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
- MRMC Study Done: No.
- Effect Size: Not Applicable (N/A) - This device is an external fixation system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study Done: No. This device is an external fixation system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not Applicable (N/A) - No clinical ground truth was established for performance evaluation against a specific diagnostic or prognostic outcome. The "ground truth" in this context refers to the material and mechanical properties of the device meeting established engineering standards and being comparable to predicate devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not Applicable (N/A) - No training set was used as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not Applicable (N/A) - No training set was used.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):
The Hoffmann LRF (Limb Reconstruction Frame) System demonstrated substantial equivalence by means of non-clinical laboratory testing.
- Study Design/Methodology: Non-clinical testing was performed in compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device."
- Tests Conducted: The testing included:
- Static and dynamic frame testing.
- Wire Strength testing.
- Compression testing.
- Bending testing.
- Slipping testing.
- Splitting testing on frame components.
- Conclusion of Testing: The testing "demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing."
- Predicate Devices: The device was compared to the following predicate devices to establish substantial equivalence in intended use, materials, and performance characteristics:
- Clinical Testing: The submission explicitly states: "Clinical testing was not required for this submission." This reinforces that the evaluation was based on non-clinical, mechanical, and material comparisons to existing devices.
§ 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.