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The NCB Periprosthetic Femur Polyaxial Locking Plate System is 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 NCB Periprosthetic Femur Plate Provisional Instruments are surgically invasive, non-sterile, reusable devices used to determine the suitable implant length during intra-operative planning as part of the implantation of the NCB Periprosthetic Femur Plates.

The provided document describes the Zimmer NCB® Periprosthetic Femur Polyaxial Locking Plate System, specifically an update with new optional provisional instruments. The performance data focuses on non-clinical testing of these provisional instruments.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for any of the tests. The document refers to "the Provisionals" and "the polyphenylsulfone material with barium sulfate," implying a representative number of samples were tested.
• Data Provenance: The studies are non-clinical (laboratory-based) and conducted by Zimmer, GmbH (Switzerland). The document does not specify a country of origin for data in the sense of clinical patient data, as no clinical studies were performed. All tests were retrospective in the sense that they were conducted on already manufactured provisional instruments and material.

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 studies are entirely non-clinical performance tests of medical device components and materials. There is no "ground truth" established by human experts in the context of diagnostic or treatment efficacy for these types of engineering and biocompatibility tests. The "ground truth" is based on objective measurements against quantifiable standards or observations by trained laboratory personnel.

4. Adjudication Method for the Test Set

• This information is not applicable for non-clinical performance tests. Adjudication methods are typically relevant for clinical studies or studies involving subjective human interpretation (e.g., image reading).

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for this device." The studies were non-clinical performance evaluations of the provisional instruments and their material.

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

• This information is not applicable. The device described is a physical medical device (surgical instruments), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• For the Bending Test: The ground truth would be established by the physical resistance and structural integrity of the provisional instruments under defined high handling forces, measured via engineering standards and metrics.
• For Radiolucency and Physico-chemical Stability: The ground truth is objective measurement of material properties (e.g., optical density for radiolucency, visual inspection for surface changes, dimensional measurements, material characterization techniques to detect degradation) before and after sterilization, compared against a baseline.
• For Cytotoxicity: The ground truth is established by standardized biological assays (e.g., ISO 10993-5) that measure the effect of leachable substances on cell cultures at a cellular level, adhering to pass/fail criteria for cytotoxicity.

8. The Sample Size for the Training Set

• This information is not applicable. There is no machine learning or AI component involved in this device or its testing, therefore no "training set" exists.

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

• This information is not applicable for the same reason as in point 8.

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The NCB Periprosthetic Femur Polyaxial Locking Plate System is 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 NCB (Non-Contact Bridging) Periprosthetic Femur Polyaxial Locking Plate System is a line of polyaxial locking plates for the treatment of femur fractures, particularly of periprosthetic femur factures. It consists primarily of Proximal Femur Plates, Distal Femur Plates, and Curved Shaft Plates. The NCB technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Periprosthetic plate acts as an internal fixator without contact between the plate and the bone surface, 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, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.

The provided document is a 510(k) summary for a medical device called the "NCB® Periprosthetic Femur Polyaxial Locking Plate System." It details the device's description, intended use, and a comparison to predicate devices, but does not describe a study involving acceptance criteria and device performance in the way typically associated with AI/software-as-a-medical-device (SaMD) clearances.

This document focuses on the mechanical and biocompatibility aspects of an implantable medical device, rather than a diagnostic or therapeutic AI algorithm. Therefore, many of the requested elements (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not present in this type of submission.

Here's an attempt to address the request based on the available information, noting where information is not relevant or unavailable:

Acceptance Criteria and Study for NCB® Periprosthetic Femur Polyaxial Locking Plate System

The acceptance criteria for this device are demonstrated through mechanical performance testing and equivalency to previously cleared predicate devices. The study conducted is non-clinical performance testing.

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

• Construct fatigue - Proximal Femur Plate
• Distal Femur Plate strength
• Shaft Plate strength
• NCB screw/Shaft Plate compression slot interface evaluation
• Construct fatigue - Proximal Femur Plate with Cable and Cable Button
  System screws were tested to determine:
• Starting load
• Driving torque
• Torque to failure

The "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." |
| Material Biocompatibility | Made of materials demonstrated to be safe for implantation. | Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy. This is implicitly accepted as safe based on widespread use of titanium alloys in predicate devices and medical implants. |
| Intended Use Equivalence | Comparable to predicate devices in intended use. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in intended use... to the predicate devices." |
| Sterility | Comparable to predicate devices in sterility. | "The NCB Periprosthetic Femur Polyaxial Locking Plate System is similar in... sterility... to the predicate devices." |
| Literature Support (Osteopenic Bone) | Use in osteopenic bone is substantiated. | "A literature review was conducted to substantiate the use of the proposed device in osteopenic bone." |

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

This information is not provided in the summary. For mechanical testing, the "sample size" would refer to the number of devices or components tested. The data provenance would be a lab setting, likely in the US or Switzerland (where the sponsor has offices). These would be prospective lab tests.

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)

This information is not applicable/provided. The "ground truth" for this device comes from engineering standards, mechanical testing results, and established material science. There isn't a human expert "ground truth" establishment in the context of diagnostic interpretation for this type of device. The expertise lies with the engineers and material scientists conducting and interpreting the lab tests.

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

This information is not applicable/provided. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). Mechanical testing results are objective measurements.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a bone fixation implant.

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

This information is not applicable. This is a physical implantable device, not a standalone algorithm.

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

The "ground truth" for this device is based on engineering standards, mechanical material property data, fatigue testing, strength testing, and torque specifications. For the "use in osteopenic bone," a literature review served as the basis for substantiation. Substantial equivalence to predicate devices is also a key component of the "ground truth" for regulatory clearance.

8. The sample size for the training set

This information is not applicable/provided. This device does not involve a "training set" in the context of machine learning.

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

This information is not applicable. There is no "training set" for this device.

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