(53 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 and 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 provided 510(k) summary describes a medical device, the MaxLock Extreme™ System, which consists of various size plates and screws for stabilizing and aiding in the fusion or repair of fractured bones.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Equivalent or superior mechanical strength to predicate devices. (Demonstrated through worst-case implant analysis and benchtop testing) | Finite element analysis (FEA) performed on subject and predicate devices to determine worst-case implant. Benchtop mechanical testing performed to validate FEA results and compare strength. The results support a determination of substantial equivalence to predicate devices. |
| Screw Performance: | |
| Equivalent or superior mechanical performance of screws compared to predicate devices. | Further benchtop testing and calculations performed on subject screws. Results led to a determination of substantial equivalence. |
| Material Composition: | |
| Use of implant-grade materials. | All implantable components manufactured from implant grade titanium alloy or PEEK. (This is a design input, not a performance criterion tested in this study but a fundamental aspect of the device). |
| Indications for Use: | |
| Appropriateness of the device for specified indications. | Indications for use are consistent with the predicate devices and the design of the MaxLock Extreme™ System. Due to similarities in indications, design, and materials with predicate devices, no other testing was required beyond mechanical and screw performance. |
| Safety and Effectiveness: | |
| No new issues of safety and effectiveness raised compared to predicate devices. | Based on the comparisons, the submission states: "No new issues of safety and effectiveness have been raised." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size for a "test set" in the context of a clinical study involving human patients. The studies described are primarily benchtop mechanical testing and finite element analysis. Therefore, the concept of data provenance (country of origin, retrospective/prospective) as it relates to human or clinical data is not applicable to the studies mentioned.
- For the finite element analysis, the "sample" would be the digital models of the subject and predicate devices used in the simulations.
- For the benchtop mechanical testing, the "sample" would be the physical implants (plates and screws) tested. The number of such implants tested is not specified but would typically involve multiple units for statistical significance in engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of studies described. "Ground truth" established by experts, particularly in the context of diagnostic interpretation, medical imaging, or clinical outcomes, is relevant for performance studies involving human data or expert review. The studies mentioned are engineering and mechanical evaluations.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among expert readers in clinical or image-based studies.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive technologies where human readers interact with AI output. The MaxLock Extreme™ System is a surgical implant, not a diagnostic or AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is also relevant for AI/software as a medical device (SaMD) where the algorithm performs a function independently. The MaxLock Extreme™ System is a physical implant.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance studies was established by engineering principles and physical measurements.
- For Finite Element Analysis (FEA), the "ground truth" for validation would be the physical behavior of materials under stress, and the output (stress, strain, displacement) is compared against theoretical models and subsequent benchtop test results.
- For Benchtop Mechanical Testing, the "ground truth" is the directly measured physical properties (e.g., yield strength, ultimate tensile strength, fatigue life, and deformation under load) of the implants according to standardized testing protocols. The comparison is made against the performance of the predicate devices.
8. The Sample Size for the Training Set
The concept of a "training set" (in the context of machine learning) is not applicable to the studies described for the MaxLock Extreme™ System. There is no AI component that requires a training set.
If interpreting "training set" in a broader engineering context as data used to refine the device design prior to final testing, this information is not provided. However, given the context, it's highly likely referring to AI/ML.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, the concept of a "training set" is not applicable.
§ 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.