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

The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method. The Tivanium 3.5 mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.

I am sorry, but the provided text is a 510(k) summary for a medical device (NCB Polyaxial Locking Plate System). It describes the device, its intended use, comparison to predicate devices, and regulatory information.

However, it does not contain the specific information required to answer your request about acceptance criteria for a study and its proving evidence.

The "Performance Data (Nonclinical and/or Clinical)" section explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that a clinical study with acceptance criteria for device performance, as you've requested, was not performed or at least not submitted as part of this 510(k). Instead, the performance data cited is: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance." This likely refers to non-clinical, benchtop testing to ensure the device meets engineering specifications, not a clinical study on patient outcomes or human reader performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This 510(k) summary is for a bone fixation system, not an AI/software device that would typically involve the type of performance evaluation you are asking about (e.g., assessing accuracy, sensitivity, specificity, and human reader improvement with AI).

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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 Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.

The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method.

The Tivanium 3.5mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.

This document describes the Zimmer NCB® Polyaxial Locking Plate System and Zimmer® Universal Locking System with 3.5mm Tivanium® Ti-6Al-4V Alloy Locking Screws. It's a 510(k) premarket notification for a Class II medical device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (bone fixation plates and screws), the "acceptance criteria" are primarily related to safety, effectiveness, and substantial equivalence to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic AI/software devices. The performance is assessed through non-clinical (laboratory/performance) testing.

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

This device is a hardware implant (plates and screws for bone fixation). The performance testing described is non-clinical (laboratory/performance) testing, not clinical trials involving human subjects or data sets in the way AI/software devices are typically evaluated.

• Sample size for the test set: Not applicable in the context of clinical data. The document does not specify sample sizes for mechanical or laboratory tests, which would typically involve testing a certain number of devices or components under simulated conditions.
• Data provenance: Not applicable. The "data" comes from laboratory and performance testing, not human-derived data like images or patient records.

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

Not applicable. Ground truth for clinical data is not relevant here as the evaluation relies on non-clinical, laboratory performance testing of the hardware. The "ground truth" for such devices is established through engineering standards, biomechanical principles, and documented performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for clinical data interpretation (e.g., in diagnostic studies) where human experts might disagree. This device was evaluated through non-clinical laboratory testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. This document pertains to a bone fixation hardware device, for which MRMC studies are not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering specifications, biomechanical testing standards, and performance characteristics established for bone fixation devices. It relies on laboratory test results demonstrating mechanical strength, fatigue resistance, biocompatibility (often implicitly covered by material commonality), and other physical properties under simulated conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product, not a machine learning model. There is no "training set" in this context.

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

Not applicable, as there is no training set.

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