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The NCB® Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

The MotionLoc Screw for Polyaxial NCB Locking Plate System is used in conjunction with the NCB Polyaxial Locking Plate System. It 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 for Polyaxial NCB Locking Plate System 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.

The provided document (K101696) describes a 510(k) premarket notification for the "MotionLoc™ Screw for NCB® Polyaxial Locking Plate System."

Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on demonstrating substantial equivalence to predicate devices through qualitative and comparative non-clinical performance data.

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

• Test Set (Non-clinical Performance Data):
  • Sample Size: The document does not provide specific sample sizes (e.g., number of constructs or screws tested) for the non-clinical fatigue, torque, or animal studies. It mentions "Construct fatigue testing," "Starting load, driving torque and torque to failure testing," and "Animal testing in an ovine tibial osteotomy model," but not the 'n' for each.
  • Data Provenance: The data is non-clinical (lab and animal testing). The country of origin is not explicitly stated, but given Zimmer, Inc. is based in Warsaw, Indiana, USA, it's reasonable to infer the testing was conducted in the USA or under US regulatory standards. The data is retrospective in the sense that it was generated for the purpose of this submission and presented as completed studies.

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

This information is not applicable as the provided document pertains to a medical device's physical and mechanical performance evaluation (non-clinical testing) for substantial equivalence, not the evaluation of an algorithm or diagnostic device requiring expert interpretation of a test set to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

No, an MRMC comparative effectiveness study was not done. The device is a bone screw system, not a diagnostic imaging or AI-assisted interpretation device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance studies, the "ground truth" was established by engineering and biomechanical principles and measurements against recognized standards (implied by the FDA's regulatory framework for mechanical performance) and comparison to the predicate device's established performance parameters. For the animal study, the outcome in the ovine model would serve as the "ground truth" for assessing biological response and initial fixation properties. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic study of a disease.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" for an algorithm or AI.

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

This information is not applicable for the same reasons as point 8.

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