MAXLOCK EXTREME SYSTEM

• K Number: K113048
• Device Name: MAXLOCK EXTREME SYSTEM
• Manufacturer: ORTHOHELIX SURGICAL DESIGNS, INC.
• Date Cleared: 2012-01-30 ( 110 days)
• Product Code: HRS , HWC
• Regulation Number: 888.3030
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K090289 , K093900 , K100618 , K102156 , K092528 , K061400 , K061098

Intended Use

The MaxLock Extreme® System is indicated for the following:

• The 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 Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Device Description

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

AI/ML Overview

The provided text describes a 510(k) summary for the MaxLock Extreme® System, which is a bone fixation device (plates/screws). This type of medical device submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information requested about acceptance criteria, test sets, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device evaluations, are not applicable to this submission.

The "study" conducted for this device to prove it meets acceptance criteria (i.e., substantial equivalence) largely relied on mechanical testing, finite element analysis, and mathematical analyses, comparing its performance to predicate devices.

Here's an breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a specific table of quantitative acceptance criteria and reported device performance in the same way an AI/ML study would (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) in this context are primarily qualitative, focusing on whether the new device can be demonstrated to be "substantially equivalent" to predicate devices without raising new issues of safety and effectiveness.

The "performance" demonstration is stated as:

• Performance: "Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses."
• Result: "No new issues of safety and effectiveness have been raised."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not applicable in the context of clinical "test sets" for performance metrics like sensitivity/specificity. The "samples" used would be physical device prototypes for mechanical testing and computational models for finite element analysis. The document does not specify the number of prototypes tested.
• Data Provenance: Not applicable for a non-clinical submission like this. The "data" comes from engineering tests and analyses, 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. Ground truth as understood in AI/ML (e.g., disease presence confirmed by experts) is not relevant here. The "truth" is established by engineering principles and comparison to known performance of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no human reading or adjudication of a test set in this context.

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. This is not an AI-assisted device. MRMC studies are not relevant to demonstrating substantial equivalence for a mechanical medical device like this.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithmic device. The "standalone" performance relates to the mechanical integrity and function of the physical plates and screws themselves, which was assessed via mechanical testing and FEA.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is based on established engineering standards for bone fixation devices and the known performance and safety profiles of the predicate devices. It relies on the physical properties and mechanical behavior of the materials and designs, validated through testing, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of the "Proof" for this Device:

The "proof" that the MaxLock Extreme® System meets its "acceptance criteria" (which in this context means "is substantially equivalent and introduces no new safety/effectiveness issues") is entirely based on:

• Mechanical Testing: Physical tests to assess strength, fatigue, and other biomechanical properties.
• Finite Element Analysis (FEA): Computational simulations to predict mechanical behavior under various loads.
• Mathematical Analyses: Calculations to support design choices and material properties.
• Comparison to Predicate Devices: Demonstrating that the results of the above analyses and tests are comparable to or better than those of previously cleared, legally marketed predicate devices (MaxLock Extreme® System previous versions, Biomet Forerunner System, OrthoHelix Calcaneal Trauma System, Biomet/E.B.I. OptiLock Periarticular Plating System).

The 510(k) process for a Class II mechanical device like this does not typically involve clinical data or the detailed AI/ML study design questions you've posed.

Regulation Number and Section

§ 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.