(63 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
Here's an analysis of the provided text regarding the MaxLock Extreme® System, focusing on the acceptance criteria and the study used to demonstrate it:
Summary of Acceptance Criteria and Device Performance for MaxLock Extreme® System
The acceptance criteria for the MaxLock Extreme® System are primarily based on its substantial equivalence to a previously cleared predicate device (K122005). The study performed to demonstrate this equivalence focused on the mechanical strength of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence | Equivalence to predicate device (K122005) in terms of indications, design, and materials. | "The new MaxLock Extreme® System is substantially equivalent to the existing OrthoHelix MaxLock Extreme® System (K122005)." | This is a regulatory declaration based on the comparison made. |
| Mechanical Strength | Strength comparable to the predicate device. | "Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence." | No specific quantitative values (e.g., yield strength, fatigue life) are provided in the summary, just the conclusion that the analysis supports equivalence. |
| Safety and Effectiveness | No new issues of safety and effectiveness raised compared to the predicate. | "No new issues of safety and effectiveness have been raised." | This is a qualitative statement based on the comparison and lack of identified concerns. |
| Indications for Use | Match the indications of the predicate device (or be a justifiable expansion). | The indications for use listed for the MaxLock Extreme® System align with the general uses for bone fixation plates and screws in various anatomical locations (pelvis, small/long bones, clavicle, foot, distal radius). | The phrasing "Due to similarities in indications, design, and materials, no other testing was required" implies alignment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial. The "test set" for this clearance was a Finite Element Analysis (FEA) model of the device. There's no mention of in-vivo or ex-vivo physical testing on a sample of devices.
- Data Provenance: The data provenance is internal to the manufacturer (OrthoHelix Surgical Designs, Inc.) as it's based on their FEA and design comparisons. Country of origin for the model/analysis is not explicitly stated but would be presumed to be where OrthoHelix operates (USA). The study is retrospective in the sense that it relied on existing information about the predicate device for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Experts for Ground Truth: Not applicable. For an FEA study comparing mechanical strength for substantial equivalence, the "ground truth" would be the engineering principles and material properties used in the simulation, along with established standards for bone fixation devices (though specific standards aren't cited in this summary). The review and approval by the FDA (specifically the Division of Orthopedic Devices at CDRH) implicitly involves expert review of the submitted data. However, there's no mention of external clinical experts establishing "ground truth" for the FEA itself.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical or reader-based test set requiring adjudication. The FDA's review process itself acts as an adjudication body for the submitted technical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This type of study is typically done for imaging or diagnostic devices where human readers interpret results. The MaxLock Extreme® System is a mechanical implant, and the clearance was based on engineering analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Standalone Study: Yes, in a way. The "study" performed was a Finite Element Analysis (FEA), which is an independent, algorithm-based simulation of the device's mechanical behavior. An FEA is a computational method that doesn't involve human-in-the-loop performance in the same way an AI diagnostic tool would. It's a "standalone" engineering simulation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this clearance relies on:
- Engineering principles and material properties: Used in the FEA to model the mechanical behavior of both the subject and predicate devices.
- Predicate device characteristics: The established mechanical performance and safety profile of the legally marketed predicate device (K122005) served as the benchmark.
- Regulatory criteria for substantial equivalence: The FDA's definition and requirements for demonstrating that a new device is as safe and effective as a predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This was not a machine learning or AI-based device requiring a training set. The FEA uses design parameters and material properties as its input, rather than a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of an AI/ML algorithm.
§ 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.