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NCB® Polyaxial Locking Plate System:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.

NCB® Periprosthetic Femur Plate System:
The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.

If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.

The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.

NCB® Cable Button:
The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.

NCB® Straight Narrow Shaft Plate
The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including periprosthetic fractures.

NCB® Polyaxial Locking Plate System
The NCB (Non-Contact-Bridging) Polyaxial Locking Plate System is a plate solution intended for the treatures and osteotomies of the distal femur (NCB DF), proximal humerus (NCB PH) and proximal tibia (NCB PT). NCB plate holes allow for polyaxial screw placement (30° cone) with subsequent screw locking, the screws can act as lag screws and be used for fracture reduction. In the locked mode, the plates act as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment.

An additional extension tuberculum minus plate can be assembled to the humeral plate with cerclage wire technique for fixation of anteroposterior (AP) tuberculum minus fractures. NCB femoral, humeral and tibial plates, cortical, cancellous and cannulated screws, locking cap, blind screw inserts and spacers are made from titanium alloy Protasul®-64 (Ti-6Al-4V - ISO 5832-3/ASTM F136). The tuberculum minus plate is made from cpTi (ISO 5832-2/ASTM F67), cortical screws from titanium alloy Protasul-100 (Ti-6Al-7Nb ISO 5832-11/ASTM F1295) and the cerclage wire from 1.4441 stainless steel Protasul-S (ISO 5832-1/ASTM F138-F139).

NCB® Periprosthetic Femur Plate System
The NCB (Non-Contact-Bridging) Periprosthetic Femur Plate System is a line of polyaxial locking plates for the treatment of femoral fractures, particularly of periprosthetic femoral fractures. The system consists of Proximal Femur Plates, Curved Shaft Plates, Trochanter Plates and a Connection Screw. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Periprosthetic Plate acts as an internal fixator without contact between the bone suface, reducing the risk of periosteal blood supply impairment. This Non-Contact Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.

Additionally, within this system, the NCB Periprosthetic Trochanter Plates used in combination with the NCB Periprosthetic Proximal Femur Plates for the treatment of proximal femoral fractures, which includes greater trochanter fractures and osteotomies. The Connection Screw for NCB Periprosthetic Trochanter Plate is used to attach the Proximal Femur Plate. The NCB Periprosthetic Trochanter Plates contain threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used.

The NCB Periprosthetic Proximal Femur Plates are available in five lengths (Length=245mm, 324mm, 363mm, 401mm) which can be used either as standalone implants or in combination with the NCB Periprosthetic Trochanter Plates. The NCB Periprosthetic Proximal Femur Plate short (Length=115 mm) is used only in combination with the NCB Periprosthetic Trochanter Plates. The NCB Curved Shaft Plates are also included in the NCB Periprosthetic Femur Plate System and are specifically designed for the femur. The Proximal Femur Plates, Distal Femur Plates, Trochanter Plates and Connection Screw are made of a titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3).

NCB Cable Button for NCB Polyaxial Locking Plate
The NCB (Non-Contact-Bridging) Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer Biomet NCB Polyaxial Locking Plate System Cerclage Cables. The Cable Button is threaded into a vacant screw hole of the Zimmer Biomet NCB Polyaxial Locking Plate System and provides a positioning point for a Cerclage Cable.

The Cable Button is made of titanium alloy (Ti-6Al-4V (Protasul®-64WF) ISO 5832-3) and has a color anodization (Type III).

NCB Straight Narrow Shaft Plate
The NCB (Non-Contact-Bridging) Straight Narrow Shaft Plate is a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3 mm spacers, which are threaded into the plate holes prior to plate insertion.

The NCB Straight Narrow Shaft Plate is made of Titanium alloy [Ti6Al4V (Protasul®-64WF) ISO 5832-3].

Here's an analysis of the provided text regarding the acceptance criteria and study for the NCB® Polyaxial Locking Plate System and related devices.

Based on the provided FDA 510(k) summary, this submission is for a medical device (bone fixation plates), not an AI/software device. Therefore, many of the requested categories related to AI/software performance metrics, ground truth, expert adjudication, and MRMC studies are not applicable.

This document describes a substantial equivalence submission for metal bone fixation implants. The "acceptance criteria" and "device performance" in this context refer to mechanical, material, and biocompatibility testing results, not AI model performance metrics like sensitivity, specificity, or F1-score.

The document states that "Clinical data and conclusions were not needed for this device," and the substantial equivalence determination relies on comparisons to legally marketed predicate devices, along with non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical medical device, the "acceptance criteria" are typically defined by recognized standards for mechanical properties, biocompatibility, and sterilization. The "reported device performance" would be the results of testing against those standards.

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

This is not applicable as this is a medical device (bone plate) and not an AI/software device with a "test set" in the computational sense. The "testing" refers to non-clinical mechanical and material tests. No patient data or clinical studies are mentioned.

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

Not applicable. "Ground truth" in the context of AI models does not apply to this type of device.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This device is not an AI product.

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

Not applicable. This device is a passive mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For a mechanical device, performance is evaluated against engineering specifications and industry standards, not "ground truth" derived from expert consensus, pathology, or outcomes data in the way an AI system is evaluated.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

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The Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include:

• · Compound and simple shaft fractures.
• · Proximal, metaphyseal and distal shaft fractures.
• · Segmental fractures.
• · Comminuted fractures.
• · Fractures involving osteopenic and osteoporotic bone.
• · Pathological fractures.
• · Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union and delayed union.
• · Periprosthetic fractures.
• · Surgically created defects such as osteotomies.
• · Intertrochanteric and subtrochanteric fractures.

The Affixus Natural Nail Humeral Nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.

• The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:
• · Proximal fractures (proximal short and long nails only).
• · Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only).
• · Open and closed fractures.
• · Comminuted fractures.
• · Nonunions and malunions.
• Pathologic fractures.

The Zimmer Natural Nail System Cephalomedullary Nails are intramedullary nails designed to restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.

The Affixus Natural Nail Humeral Nail System consists of temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. The nails restore the shape of preinjured bone and they are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.

The Ante/Retrograde Humerus Nails, Ante/Retrograde Humeral Nail Caps, Proximal Humerus Nail Caps, Washers, Cortical Bone Screws, and Blunt Tip Screws are made of Titanium alloy [Protasul®-64WF (Ti-6Al-4V) ISO 5832-3/ASTM F136] and Proximal Humerus Nails are made of Titanium alloy [Protasul-64WF (Ti-6AI-4V) ISO 5832-3/ASTM F136] and C.P Titanium [Protasul®-Ti ISO 5832-2/ASTM F67].

Package labels indicate the material of each component. Selected components of the Affixus Natural Nail Humeral Nail System instruments are color coded to aid in identifying which components should be used together. Refer to the surgical techniques for more detailed instructions on the use of Affixus Natural Nail Humeral Nail System components.

The purpose of this traditional bundled 510(k) is to update the Instructions for Use (IFU) and labels of the Zimmer® Natural Nail® System Cephalomedullary Nails and Affixus® Natural Nail® Humeral Nail System to include MR Conditional labeling. Additionally, to harmonize the content format of the IFU, some chapters of the IFUs are reorganized.

This 510(k) summary does not contain information on acceptance criteria for a device, nor does it present a study to prove a device meets acceptance criteria related to clinical performance. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices, primarily due to updates in labeling for MR Conditional compatibility and harmonization of IFU format.

Here's a breakdown of the relevant information from the provided text:

• No Clinical Acceptance Criteria or Performance Data: The document explicitly states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." This indicates that the submission is not based on proving clinical effectiveness against specific acceptance criteria.
• Focus on Substantial Equivalence: The primary purpose of this 510(k) is to update labeling (specifically for MR Conditional use) and re-organize the Instructions for Use (IFU) for existing devices. The submission asserts substantial equivalence to legally marketed predicate devices based on identical intended use, indications for use, device description, materials, design features, lengths and diameters, and sterilization methods.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance from this document because it is not a clinical performance study.

However, I can extract the information related to the non-clinical performance testing conducted to support the MR Conditional labeling:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

   Acceptance Criteria Description (Based on ASTM Standard)	Reported Device Performance (Implied adherence to standard)
   ASTM F2503-20 (Labeling)	Devices meet labeling requirements for MR Conditional.
   ASTM F2119-07R13 (Artifact)	Devices demonstrate acceptable artifact levels in MRI.
   ASTM F213-17 (Torque)	Devices exhibit acceptable torque behavior in MRI.
   ASTM F2052-21 (Displacement Force)	Devices show acceptable displacement forces in MRI.
   ASTM F2182-19E02 (RF-heating) Preliminary Phantom Eval.	Devices have acceptable RF-heating characteristics in MRI (preliminary phantom evaluation).

2. Sample size used for the test set and the data provenance: Not specified in the document. Testing would typically involve representative samples of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Non-clinical testing for MR compatibility is typically performed by engineers/technicians in a laboratory setting, following established ASTM protocols.

4. Adjudication method for the test set: Not applicable. Results are typically quantitative measurements compared against predefined limits within the ASTM standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a non-clinical submission for MR compatibility labeling updates, not a clinical effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an AI/algorithm-based device.

7. The type of ground truth used: For the non-clinical MR compatibility testing, the "ground truth" is defined by the limits and methodologies specified in the referenced ASTM standards.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.

9. How the ground truth for the training set was established: Not applicable.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

When a kinematic alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, stem extension, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Personalized Knee System includes surgical instrumentation that facilitate implantation of the above described implant components.

The purpose of this submission is the introduction of an optional alternative surgical technique for distal femoral resection that enables for gap balancing and femoral external rotation, accomplished via the use of a new instrument platform including a femoral rotation guide and anterior-posterior cutting blocks. The resection of the proximal tibia is performed in accordance with the standard Persona Primary Knee Surgical Technique.

The new instruments do not change the intended use or fundamental scientific technology of the Persona Personalized Knee System components.

This document describes the 510(k) premarket notification for the Zimmer Persona® Personalized Knee System, focusing on the introduction of an optional alternative surgical technique and new instrumentation. It is a submission for a Class II medical device (knee prosthesis).

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.

The submission is for a knee prosthesis and associated surgical instrumentation. The "Performance Data" section explicitly states:

• Non-Clinical Performance and Conclusions:
  • Biocompatibility assessment
  • Cadaveric design validation
  • Design Verification Modular Brackets
• Clinical Performance and Conclusions:
  • Clinical data and conclusions were not needed for this device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as this document pertains to a traditional medical device (knee implant and instruments) that did not require clinical data or AI/ML performance evaluation for its 510(k) clearance.

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