(59 days)
The MaxLock Extreme System is indicated for the following:
- •The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
- · The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
- ·The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
- ·The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK
The MaxLock Extreme® System is an orthopedic device used for bone fixation. Here's an analysis of its acceptance criteria and the study that proves its equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K113048) | Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence. |
| Safety and Effectiveness | No new issues of safety and effectiveness have been raised. |
| Indications for Use | The MaxLock Extreme® System has similar indications for use as the predicate device, covering various bone fracture fixations and osteotomies in adult and pediatric patients for different body regions. |
| Design | Similar design to the predicate device. |
| Materials | Similar materials (Titanium Alloy, PEEK) to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The submission states that "Finite element analysis comparing the strength of the subject and predicate devices was performed." This indicates that a physical test set of devices was not used in a clinical or benchtop comparative manner. Rather, the equivalence was demonstrated through a computational method (finite element analysis).
- Test Set Sample Size: Not applicable in the traditional sense of physical devices. The "sample" here refers to the parameters and models used in the finite element analysis. The number of such models or scenarios is not specified.
- Data Provenance: The finite element analysis is a computational study. Therefore, there is no country of origin for external data, and it is not retrospective or prospective in the clinical sense. The data used in the analysis would be material properties and geometric models of the devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. For a finite element analysis, "ground truth" typically refers to established engineering principles, material properties, and computational modeling standards. Experts in biomechanical engineering or materials science would be involved in performing and validating such an analysis, but they are not establishing a "ground truth" in the clinical sense (e.g., diagnosing a condition).
- Qualifications of Experts: Not specified, but generally, experts conducting finite element analyses in this context would be engineers with expertise in mechanical engineering, biomechanics, and material science.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the evaluation was based on finite element analysis, there isn't a need for expert adjudication that would be used for clinical interpretations or image assessments. The validation of the finite element model and its results would typically follow established engineering validation protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone fixation system, not a diagnostic imaging device. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, a standalone study (in the context of an algorithm's performance without human intervention) was not conducted. The evaluation method was a finite element analysis comparing the mechanical strength of the new device to a predicate device, not an algorithmic performance assessment.
7. Type of Ground Truth Used
- Ground Truth Type: Not applicable in the clinical sense. For the finite element analysis, the "ground truth" relies on established engineering principles, validated material properties, and the accuracy of the computational models used to represent the devices and the forces they would experience. The aim was to demonstrate equivalent mechanical performance.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. Finite element analysis is not a machine learning approach that typically involves training sets. It is a simulation method based on physical laws and material properties.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of finite element analysis.
§ 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.