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MotionLoc Screws, when used with the NCB Proximal Humeral or NCB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

• Comminuted fractures
• Fractures in osteopenic bone
• Nonunions/Malunions

MotionLoc Screws, when used with the NCB Distal Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

• Comminuted fractures
• Supracondylar fractures
• Fractures in osteopenic bone
• Nonunions/Malunions

MotionLoc Screws, when used with the NCB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:

• Periprosthetic fractures
• Comminuted fractures
• Fractures in osteopenic bone
• Nonunions/Malunions

MotionLoc Screws, when used with the NCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:

• Periprosthetic fractures
• Comminuted fractures
• Supracondylar fractures
• Fractures in osteopenic bone
• Nonunions/Malunions

The MotionLoc Screw is a member of the NCB Screw family and is used as an alternative for standard NCB Screws in applications where a surgeon desires reduced stiffness in a construct.

The MotionLoc Screw has a standard NCB Screw front thread section, a mid-section with a reduced core-diameter, a collar region, and a standard NCB Screw head for engagement in NCB locking plates. The MotionLoc Screws provide unicortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The NCB technology allows for polyaxial screw placement (30° cone) of the MotionLoc Screws with screw locking achieved using previously cleared Locking Caps (K042695, cleared 10/29/2004) that are threaded into the plate holes.

In the locked mode the NCB plate acts as an internal fixator without contact between the plate and the bone surface thus reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers (also previously cleared in K042695), which are threaded into the plate holes prior to plate insertion. Plates, screws, spacers and locking caps are made of titanium alloy.

Here's a breakdown of the acceptance criteria and study information for the Zimmer MotionLoc™ Screw for NCB® Polyaxial Locking Plate System, based on the provided document:

This 510(k) submission is for an extension of indications for an already cleared device, not a new device requiring extensive clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that the changes in indications or usage do not negatively impact the safety and effectiveness, and that the device remains substantially equivalent to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Since this is primarily a non-clinical (lab) performance study with literature review for osteopenic bone, the concept of a "test set" in the same way as a clinical trial with patient data is not applicable.

• Mechanical Testing (Axial and Torsional Fatigue): The document does not specify the exact sample size (number of constructs tested) for the axial fatigue strength and torsional fatigue tests. This information is typically detailed in the specific test reports submitted to the FDA but is summarized in the 510(k).
• Data Provenance: The document does not explicitly state the country of origin for the lab testing. It's safe to assume it's retrospective relative to the 510(k) submission, meaning the tests were conducted prior to the submission. The literature review for osteopenic bone would draw from published studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable in the context of this 510(k) summary. This submission did not involve a clinical study for which human experts would establish "ground truth" on performance relative to a disease state or imaging interpretation. The "ground truth" for the non-clinical tests is established by engineering principles and test standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no human judgment or interpretation requiring an adjudication process for the non-clinical lab tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done. This type of study is typically used for diagnostic devices that require human interpretation (e.g., radiology images) to assess the impact of AI assistance on human reader performance. This device is a surgical implant.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For mechanical performance (fatigue, strength): Engineering standards, physical measurements, and established biomechanical principles.
• For biological aspects (biocompatibility, sterilization): International standards (ISO 10993-1), FDA regulations (21 CFR § 58), and industry best practices.
• For osteopenic bone indication: Peer-reviewed medical literature.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set was used.

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