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The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:

• · Periprosthetic fractures
• Comminuted fractures
• Supracondylar fractures
• Trochanteric fractures
• · Fractures in normal and osteopenic bone
• Non-unions and Malunions.

The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.

The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.

The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.

The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates

The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.

The provided document is a 510(k) summary for the Versalock Periprosthetic Femur Plates System - GMReis. This document outlines the regulatory submission for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, many of the requested sections related to clinical studies, sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance will not be available in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of explicit acceptance criteria with specific numerical targets. Instead, it states that performance was demonstrated through mechanical testing according to established ASTM standards. The "performance" in this context refers to the device's mechanical integrity and functionality, rather than a clinical outcome.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This document describes mechanical testing of physical device components, not a study involving patient data or a "test set" in the context of AI/diagnostic device performance. The sample sizes would refer to the number of plates, screws, and cables tested in the lab. This specific number is not provided, though it would typically be defined by the ASTM standards.
• Data Provenance: Not applicable. The data comes from internal mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically defined for diagnostic AI/clinical studies (e.g., expert consensus on images, pathology results) is not relevant to this type of device submission. The "ground truth" here is the adherence to mechanical engineering standards, which is determined by test procedures and measurement against those standards.

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

• Not applicable for the reasons stated above.

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 a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

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

• No. This is a physical medical implant device, not an algorithm.

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

• For the non-clinical performance (mechanical testing), the "ground truth" is adherence to established engineering standards (ASTM F382, ASTM F543, ASTM F2180) and a risk assessment based on biocompatibility standards (ISO 10993-1).
• For the substantial equivalence claim, the "ground truth" is the characteristics of the predicate device, which the subject device is compared against.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

• Not applicable. There is no training set.

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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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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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