(112 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.
The provided text describes a medical device submission (K163656) for the Hoffmann LRF System. It focuses on regulatory approval and comparison to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.
Therefore, many of the requested elements (acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a mechanical external fixation system.
However, I can extract information related to the performance data presented within the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate devices | Static Compression: Passed (Demonstrated substantial equivalence to predicate systems) |
| Dynamic Compression: Passed (Demonstrated substantial equivalence to predicate systems) | |
| Device performs as intended | Performed as intended, and at least as well as predicates. |
Note: The document implicitly defines "acceptance criteria" through the comparison to predicate devices, where the subject device must demonstrate equivalent or superior mechanical performance. Specific numerical acceptance values are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable / Not provided. The testing described is non-clinical mechanical testing, not a test set of data points as in an AI study.
- Data provenance: Not applicable. The data comes from "Comparative mechanical testing," implying laboratory tests, not patient data.
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)
Not applicable. This was mechanical testing, not a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was 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. This is not an AI/algorithm-driven device, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is established engineering standards and comparative performance against predicate devices.
8. The sample size for the training set
Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
§ 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.