Search Results

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Cephalomedullary nails 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 Zimmer® Natural Nail® System Cephalomedullary Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They 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. A screw case that holds unused screws intended for resterilization is available and contains designated sections for each screw size. 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 provided document, K192312, is a 510(k) premarket notification for a medical device: the Zimmer Natural Nail System Cephalomedullary Nails. It details the substantial equivalence of the device to existing predicate devices.

Based on the provided text, there is no information about an AI/algorithm-driven device or its performance criteria. The document exclusively discusses an intramedullary fixation rod for fracture fixation and stabilization of the bone.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample sizes for test sets or data provenance for an AI/algorithm.
• Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
• Adjudication methods for an AI/algorithm's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/algorithm.
• Standalone AI/algorithm performance.
• Type of ground truth used for AI/algorithm.
• Sample size for training set or how ground truth was established for an AI/algorithm and its training set.

The document explicitly states under "Performance Data (Nonclinical and/or Clinical)":

• "Non-Clinical Performance and Conclusions: Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical integrity testing and design control amendments, not on a clinical performance study involving AI or human interpretation of images.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur 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 Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include:

• Compound and simple shaft fractures
• Proximal, metaphyseal, and distal shaft fractures
• Segmental fractures
• Closed supracondylar fractures
• Severely comminuted supracondylar fractures with articular involvement
• Fractures involving femoral condyles
• Comminuted fractures
• Fractures involving osteopenic and osteoporotic bone
• Pathological fractures
• Fractures with bone loss
• Pseudoarthrosis, non-union, and mal-union
• Periprosthetic fractures
• Poly trauma patients

The Zimmer Natural Nail System is a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet the assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are made of Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.

This K172114 Premarket Notification for the Zimmer Natural Nail System (specifically 6.0mm Fixed Angle Screws) primarily focuses on demonstrating substantial equivalence through mechanical testing data rather than on AI/ML algorithm performance. Therefore, many of the requested data points related to AI/ML studies are not applicable or cannot be extracted from this document.

However, I can provide the information that is present concerning the device's performance through non-clinical testing.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "new mechanical testing data for the Zimmer Natural Nail System - 6.0mm Fixed Angle Screws... is different than the performance specifications submitted in the original premarket notifications." This implies that performance data was collected and compared to established specifications from the predicate devices, but the specifics are not provided in this summary.

The non-clinical tests performed were:

• Screw Three Point Bend Test
• Proximal Nail Fatigue Construct Test
• Distal Nail Fatigue Construct Test

The document states, "Testing has been performed to establish product non-pyrogenicity" which is a biological safety characteristic, not a performance metric in the same vein as mechanical tests.

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

The document does not specify sample sizes for any of the mechanical tests performed (e.g., number of screws, nails tested).
The provenance of the data is not explicitly stated beyond being collected for this premarket notification. It can be inferred to be prospective testing conducted by Zimmer Inc.

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

Not applicable. This document describes mechanical testing of a medical device, not an algorithm that requires a ground truth established by human experts.

4. Adjudication Method for the Test Set

Not applicable. This document describes mechanical testing of a medical device, not an algorithm that requires an adjudication method for human expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This document pertains to the mechanical performance of an orthopedic implant, not an AI/ML diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This document pertains to the mechanical performance of an orthopedic implant, not an AI/ML algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the established mechanical performance specifications or industry standards against which the device was tested. The document implies that new mechanical testing data was gathered and compared to the performance specifications of the predicate devices. Specific standards (e.g., ISO, ASTM) are not cited in this summary, but these would typically form the basis of such "ground truth" for mechanical testing.

8. Sample Size for the Training Set

Not applicable. This document pertains to mechanical testing of a physical medical device. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical device's mechanical testing.

In summary, this 510(k) pertains to a traditional medical device (intramedullary fixation system) and its mechanical performance, not an AI/ML enabled device. Therefore, the information typically requested for AI/ML device studies (such as expert consensus, test set/training set details, MRMC studies) is not present in this document. The "study" described herein involves non-clinical mechanical testing, with the aim of demonstrating that the new mechanical data results in substantial equivalence to the predicate devices.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: .

• . 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 .

When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.

The ZNN Tibial Nail System is a cannulated, intramedullary rod intended to restore the shape of the injured tibia to its pre-injured state. The nail implants are available in a variety of lengths and diameters to meet assorted anatomical needs and come in both Ti-6Al-4V alloy and 22-13-5 stainless steel to address surgeon preference. Minor modifications have been made to some of the instrumentation associated with the ZNN Tibial Nail System and to the surgical technique to allow implantation through an incision above the natural patella.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Clinical data and conclusions were not needed for this device."

Therefore, there was no "test set" in the traditional sense of a clinical study involving patients. The performance data relied on "design verification activities." The document does not provide details on the sample size or provenance of data used for these design verification activities (e.g., number of tests, materials tested, etc.).

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission is for a modification to an existing device, and clinical data was deemed unnecessary.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a physical medical device (intramedullary fixation rod), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on engineering design verification and validation activities rather than clinical outcomes or expert consensus on patient data. This includes evaluations of the instruments and the surgical technique to ensure they perform as intended and safely.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI algorithm requiring a training set.

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

Not applicable, as there was no training set for an AI algorithm. The performance of the modified device was established through non-clinical design verification activities to demonstrate substantial equivalence to the predicate device.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Cephalomedullary nails 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 Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. These devices are made from Ti-6Al-4V alloy and are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short. This document focuses on demonstrating that the modified device is substantially equivalent to existing predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information cannot be directly extracted from this document, as it outlines a different type of regulatory submission.

However, I can extract information regarding the performance data used to support the substantial equivalence claim.

Here's a breakdown of what can be inferred and what cannot:

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

• Acceptance Criteria: The document does not explicitly state numerical "acceptance criteria" in the way a clinical trial would (e.g., target specificity or sensitivity values). Instead, the implicit acceptance criterion is that the modifications "would not affect safety and effectiveness" when compared to the predicate devices.
• Reported Device Performance:
  • Fatigue strength evaluation: Performed on the proximal segment of the subject nail.
  • Distal tip evaluation: Assessment of tensile stress under cantilever loading.
  • Conclusion: "The results of non-clinical (lab) performance testing demonstrate that the subject devices are safe and effective and substantially equivalent to the predicate devices."

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

• Sample Size: This is not specified for the non-clinical testing. It would typically be a engineering test sample size, not human subjects.
• Data Provenance: "Non-clinical (lab) performance testing." This implies in-vitro or bench testing, not data from human subjects or clinical settings.

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

• Not Applicable. For non-clinical (lab) performance testing of mechanical properties, "ground truth" is established through engineering and material science principles and measurements, not expert clinician consensus.

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

• Not Applicable. As this involves direct mechanical testing, there is no need for adjudication as typically seen in clinical image interpretation or diagnosis.

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 document describes the regulatory approval of a hardware medical device (intramedullary nail), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant here.

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

• No. This is not an algorithm-only device.

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

• Engineering/Material Science Standards: The "ground truth" for the non-clinical tests would be established by industry standards, engineering specifications, and validated measurement techniques for fatigue strength and tensile stress.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of this type of non-clinical mechanical performance testing.

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

• Not Applicable.

Summary Table of Available Information:

This document is primarily concerned with showing substantial equivalence to existing devices through engineering tests, rather than a clinical trial with human subjects and diagnostic performance metrics.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include: Compound and simple shaft fractures, Proximal, metaphyseal, and distal shaft fractures, Segmental fractures, Closed supracondylar fractures, Severely comminuted supracondylar fractures with articular involvement, Fractures involving femoral condyles, Comminuted fractures, Fractures involving osteopenic and osteoporotic bone, Pathological fractures, Fractures with bone loss, Pseudoarthrosis, non-union, and mal-union, Periprosthetic fractures, Poly trauma patients.

The Zimmer Natural Nail System Retrograde Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They are inserted into the femur in a retrograde mode and are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are manufactured from Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.

This document refers to a 510(k) premarket notification for the Zimmer® Natural Nail™ System Retrograde Femoral Nail. The device is an intramedullary fixation rod. The 510(k) summary explicitly states that clinical data and conclusions were not needed for this device (Page 1, "Clinical Performance and Conclusions"). This means the device approval did not rely on studies demonstrating its performance against acceptance criteria in a clinical setting.

Instead, the approval was based on non-clinical (lab) performance testing demonstrating that the devices are safe, effective, and substantially equivalent to predicate devices. The listed tests are mechanical in nature, assessing the physical properties and durability of the nail and screws.

Given this, I cannot provide the detailed information requested in your prompt as the study described in the document is a non-clinical, mechanical testing study, not a clinical study involving human subjects or AI performance.

Therefore, the following information is not applicable or extractable from the provided document:

1. A table of acceptance criteria and the reported device performance (for clinical performance): Not applicable, as no clinical performance study was conducted. The document lists mechanical performance tests (e.g., fatigue, torsional stiffness, insertion load) but does not provide specific acceptance criteria or quantitative results for these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical test set was used. For the non-clinical tests, sample sizes for mechanical testing are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is a medical device for fracture fixation, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance:

• Acceptance Criteria (Mechanical Testing): Not explicitly stated in terms of quantitative values. The general criterion is that the device "demonstrates that the devices are safe and effective and substantially equivalent to the predicate devices."
• Reported Device Performance (Mechanical Testing): The document states "The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." Specific quantitative results are not provided in this 510(k) summary.
• Study Type: Non-clinical (lab) performance testing, focusing on mechanical properties, not clinical efficacy or diagnostic accuracy.
• Tests Performed: Proximal Nail Fatigue Test, Distal Nail Fatigue Test, Midshaft Nail Analysis, Nail Torsional Stiffness Analysis, Screw Bending Fatigue Test, Screw Insertion Load Test, Screw Insertion Torque Test, Screw Torque to Failure Test, and Shelf Life Testing of UHMWPE.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Cephalomedullary nails 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 Zimmer Natural Nail System Cephalomedullary Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired.

The provided document does not contain information about an AI/ML device, nor does it describe a study involving acceptance criteria or performance metrics in the context of an AI/ML device.

The document is a 510(k) summary for a medical device called the "Zimmer Natural Nail System Cephalomedullary Nails," which is an intramedullary fixation rod for fracture stabilization.

Here's why the requested information cannot be extracted:

• No AI/ML Device: The device described is a physical orthopedic implant. There is no mention of artificial intelligence, machine learning, algorithms, image analysis, or any software-based diagnostic or prognostic tool.
• Focus on Substantial Equivalence: The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way an AI/ML model would.
• Performance Data: The document explicitly states: "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This indicates that clinical studies, which would typically generate the kind of performance data (e.g., accuracy, sensitivity, specificity) relevant to AI/ML device acceptance criteria, were not required or performed for this specific submission. The submission relied on non-clinical (lab) performance testing to show substantial equivalence.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text pertains to a different type of medical device and regulatory pathway that does not involve AI/ML performance evaluation.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for the Tibial nails include the following in the tibia:

• 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

Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur 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 Zimmer Natural Nail System Stainless Steel Tibial Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the tibia. The Zimmer Natural Nail System Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. All nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. All components are made from stainless steel.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer® Natural Nail™ System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Clinical data and conclusions were not needed for this device."

This indicates that:

• No test set using human data was employed.
• No data provenance (country of origin, retrospective/prospective) is applicable for a clinical test set.
• The evaluation was based on non-clinical (lab) performance testing and comparison to predicate devices, not on a test set involving patient data.

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

• Not applicable. As clinical data was not used, there was no need for experts to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document indicates that clinical data and conclusions were not needed, and the evaluation was based on non-clinical testing and substantial equivalence to predicate devices. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is an intramedullary nail system, a physical surgical implant, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Non-clinical (lab) performance testing: This would involve engineering and biomechanical tests to assess mechanical properties, durability, and other physical characteristics. The "ground truth" here is derived from measurable physical properties and engineering standards.
• Comparison to predicate devices: The device's "ground truth" for safety and effectiveness is largely based on its similarity to previously cleared devices which have an established record of safety and effectiveness.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur 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 Zimmer Natural Nail System Antegrade Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. All components are available in Ti-6Al-4V alloy.

This document is a 510(k) Premarket Notification for the Zimmer® Natural Nail™ System. It does not describe an AI/ML device or software that requires acceptance criteria based on performance studies.

Therefore, the prompt's request for information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not applicable to this document.

The document states:

• "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
• "Non-Clinical Performance and Conclusions: The results of non-clinical testing demonstrate that the devices are safe and effective."

This indicates that the device's safety and effectiveness were solely demonstrated through non-clinical testing, likely mechanical testing, material characterization, and comparison to predicate devices, rather than through clinical performance metrics involving human readers or AI algorithms.

Ask a specific question about this device

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: 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.

The Zimmer Natural Nail System Tibial Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The intramedullary nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and extend the length of the nail. All components are made of TI-6AL-4V alloy material.

The provided text describes a 510(k) premarket notification for the Zimmer® Natural Nail™ System Tibial Nail. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria.

Therefore, the document explicitly states: "Clinical data and conclusions were not needed for this device." This means that many of the requested elements for a study proving device performance against acceptance criteria are not applicable or available in this submission.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not applicable due to the nature of a 510(k) submission:

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

• Not Applicable in this 510(k) submission for clinical performance.
• The device's safety and effectiveness were demonstrated through non-clinical (lab) performance testing and by showing substantial equivalence to predicate devices, not by meeting specific clinical acceptance criteria.

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

• Not Applicable for clinical performance testing.
• No human-based "test set" for clinical data was used or described. The submission is based on non-clinical (lab) testing and comparison to predicate devices.

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)

• Not Applicable.
• Since no clinical test set was used to assess performance against a ground truth, no experts were needed for this purpose.

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

• Not Applicable.
• No clinical test set requiring adjudication was used.

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 an intramedullary nail for fracture fixation, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not Applicable.
• This device is a physical medical implant, not an algorithm or software-only device.

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

• Not Applicable for clinical performance.
• For the non-clinical lab testing, the "ground truth" would be engineering specifications and accepted standards for mechanical properties and material science.

8. The sample size for the training set

• Not Applicable.
• As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not Applicable.
• No training set was used.

Summary of Device Performance and Basis for Clearance (Extracted from the Text):

The Zimmer® Natural Nail™ System Tibial Nail was cleared based on:

• Non-Clinical Performance: The results of "non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
• Substantial Equivalence: The device is considered "similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices."
  • Predicate Devices:
    • Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)
    • Sirus® Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, cleared January 31, 2005)
    • DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003)

This 510(k) submission did not require clinical performance data because it demonstrated substantial equivalence to legally marketed predicate devices through robust non-clinical testing.

Ask a specific question about this device