Search Results

The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

• Supracondylar fractures, including those with intra-articular extension
• Combination of ipsilateral condylar and diaphyseal fractures
• Ipsilateral femur/tibia fractures
• Femoral fractures in multiple trauma patients
• Periprosthetic fractures
• Fractures in the morbidly obese
• Fractures in osteoporotic bone
• Impending pathologic fractures
• Malunions and nonunions

The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System). It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the structure of your request.

This document describes a traditional medical device (an intramedullary nail for fracture stabilization) and its substantial equivalence to a predicate device. The "tests results meet established acceptance criteria" mentioned in the non-clinical and/or clinical tests summary section refers to mechanical and material performance tests for the physical implant, not the performance of an AI/ML system.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on the provided text. The document does not describe:

• A table of acceptance criteria for an AI/ML device or its reported performance.
• Sample sizes for AI/ML test sets or data provenance.
• Number/qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML test sets.
• MRMC comparative effectiveness studies.
• Standalone AI algorithm performance.
• Types of ground truth for AI/ML.
• Training set sample sizes for AI/ML.
• Ground truth establishment for AI/ML training sets.

The text focuses on the device's indications for use, its mechanical properties, and its substantial equivalence to existing devices based on physical design changes (specifically, the option to remove an "inlay" from the nail).

Ask a specific question about this device

The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

• Supracondylar fractures, including those with intra-articular extension
• Combination of ipsilateral condylar and diaphyseal fractures
• Ipsilateral femur/tibia fractures
• Femoral fractures in multiple trauma patients
• Periprosthetic fractures
• Fractures in the morbidly obese
• Fractures in osteoporotic bone
• Impending pathologic fractures
• Malunions and nonunions

The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions. The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts.

The provided text ({0}-{5}) does not contain information about acceptance criteria or a study that uses a test set, ground truth, or human readers for performance evaluation. This document is a 510(k) premarket notification letter for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System and Locking Screws).

The text explicitly states:
"Clinical testing was not necessary for the determination of substantial equivalence." (Page 4, under "Clinical Performance Data")

Instead, the submission relies on non-clinical performance data to demonstrate substantial equivalence to predicate devices. These non-clinical tests are primarily mechanical and material tests conducted according to ASTM standards.

Therefore, I cannot populate the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The information that is present regarding performance comes from non-clinical engineering tests:

• Non-clinical Performance Data for Retrograde Femoral Nail Advanced System:

  • Static Bend according to ASTM F1264
  • Static Torsion according to ASTM F1264
  • Dynamic Bend according to ASTM F1264
  • Mechanical Static Construct
  • Poly Inlay Screw Pull Out Test and Debris Evaluation

• Non-clinical Performance Data for DePuy Synthes Locking Screws for Medullary Nails, 5.0:

  • Torsional Properties according to ASTM F543
  • Driving Torque & Axial Pushout according to ASTM F543
  • Driving Torque according to ASTM F543
  • Self-tapping Performance according to ASTM F543
  • Finite Element Analysis for 3-Point Bending according to ASTM 1264

• Other Additional Analysis:

  • Endotoxin Testing according to AAMI ST72
  • MRI Conditional analysis performed (though not released with MR Conditional labeling)

These tests are designed to show that the mechanical properties and safety (e.g., in terms of materials and manufacturing) of the new device are comparable to those of existing, legally marketed predicate devices, thereby establishing "substantial equivalence" without requiring human-data-based clinical performance studies.

Ask a specific question about this device

The AOS ESTM Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, and tumor resections, supracondylar fractures, including those with severe comminution and intra- articular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and fractures resulting from osteoporosis.

The AOS Extended Short™ (ES) Retrograde Femoral Nail is a single use, open reduction and internal fixation device, for the intramedullary fixation of fractures of the femur. The device is meant as a load sharing device, and it may be removed once the fracture has healed. The device consists of a nail, distal captured cortical and cancellous screws, proximal captured cortical screws, a locking spacer, fixation nuts and washers, and end caps.

This document describes the AOS ES™ Retrograde Femoral Nail, a device for intramedullary fixation of femoral fractures. The 510(k) summary provided here focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against clinical outcomes. Therefore, the "acceptance criteria" discussed are primarily related to mechanical performance testing for substantial equivalence, not clinical accuracy or diagnostic performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device through functional testing and strength comparison analysis. Specific numerical acceptance criteria are not explicitly stated as this is a 510(k) submission for a Class II medical device, generally aiming for equivalence rather than new performance benchmarks.

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

• Sample Size: Not specified. The document only mentions "functional testing and strength comparison analysis" without detailing the number of units tested.
• Data Provenance: This refers to pre-clinical (benchtop) testing, not clinical data, as it's a device for mechanical fixation. Therefore, there's no "country of origin of the data" in the clinical sense, and the testing is inherent to the device's design and manufacturing process. It's a prospective design verification.

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

Not applicable. This is not a diagnostic device requiring expert interpretation of results to establish ground truth. Substantial equivalence was demonstrated through preclinical bench testing, where performance is measured against established engineering and mechanical standards.

4. Adjudication Method for the Test Set

Not applicable. Since the evaluation is based on mechanical performance testing against engineering standards or comparison to a predicate, there's no ambiguity requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant for fracture fixation, not a diagnostic or AI-assisted imaging device that would typically involve human readers.

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

Not applicable. This is a physical medical device (femoral nail), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Engineering specifications and design requirements.
• Performance data from the predicate device to which substantial equivalence is being claimed.
• Established mechanical testing standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device

The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including:

• · Femoral shaft fractures
• · Ipsilateral femur fractures
• · Supracondylar fractures, including those with intra-articular extension
• · Osteoporotic fractures
• · Pathologic/impending pathologic fractures
• · Malunions/nonunions

The device is intended to stabilize fragments of the fracture until bony union can occur.

The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts:

• A femoral nail with proximal portals for passage of cortical locking screws and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
• Cortical locking screws will be provided separately. The cortical locking screws are provided for proximal fixation if desired.
• Universal cortical locking screws will be provided separately. The universal cortical locking screws provide increased purchase in cancellous bone and are provided for proximal fixation if desired.
• A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.

ODi-NA will manufacture the implants from implant grade titanium alloy.

The provided text is a 510(k) premarket notification for a medical device called the Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail System. It describes the device, its indications for use, and claims substantial equivalence to a predicate device.

However, the document does not contain the detailed acceptance criteria for a study proving device performance, nor does it describe a study with the specific elements requested in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone algorithm performance, training set details, or how ground truth was established for a training set).

The document states:

• "Mechanical Data: Review of the mechanical test data indicates the Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is substantially equivalent to the previously cleared Stryker® T2 Femoral Nail System (K112059, K081152, K021744)."

This sentence indicates that mechanical testing was performed, and the results were reviewed to demonstrate substantial equivalence to a predicate device. However, the details of these mechanical tests, including specific acceptance criteria and the results comparing the Talon™ DistalFix™ system to these criteria, are not provided in this document.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as requested, as that information is not present in the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with the metrics you've outlined.

Ask a specific question about this device

The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.

The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.

The provided text describes a medical device, the "AOS Retrograde Femoral Nail System," and its submission for 510(k) clearance. However, it does not contain a study that proves the device meets acceptance criteria in the way typically required for AI/ML-based medical devices (i.e., with performance metrics like sensitivity, specificity, or F1-score derived from clinical data).

Instead, this document describes a traditional 510(k) submission for a mechanical medical device (an intramedullary fixation rod). The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through preclinical mechanical testing.

Therefore, I will interpret "acceptance criteria" as meeting the performance of predicate devices in mechanical testing and "study" as the preclinical mechanical testing performed.

Here's an analysis based on the provided text, modified to fit the context of a mechanical medical device:

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

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

• Sample Size: The document does not specify the exact number of devices tested (sample size) for the preclinical mechanical testing. It mentions "The AOS Retrograde Femoral Nail System" was subjected to testing, implying a representative set.
• Data Provenance: The testing was preclinical (laboratory-based mechanical testing) and conducted by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA. This would be considered prospective, as the testing was done directly for this submission.

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 question is not applicable to preclinical mechanical testing. The "ground truth" for mechanical testing is established by standard engineering principles and test methods (e.g., ASTM F384), not by expert human interpretation.

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

This question is not applicable to preclinical mechanical testing. Adjudication methods are relevant for clinical studies where human interpretation or consensus is needed to establish ground truth or assess outcomes.

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

This question is not applicable. The device is a physical, mechanical implant (intramedullary nail), not an AI/ML-based diagnostic or assistive software. Therefore, there are no "human readers" or "AI assistance" in the context of this device's performance evaluation.

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

This question is not applicable. The device is not an algorithm or AI system. Its performance is assessed as a standalone mechanical product in a laboratory setting. The "performance" described refers to its physical characteristics and durability.

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

The "ground truth" in this context is defined by the standardized mechanical test methods (ASTM F384). The performance of the predicate devices under these conditions serves as the reference for substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no AI/ML algorithm involved, so there is no "training set."

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

This question is not applicable as there is no training set for an AI/ML algorithm.

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 Titanium Retrograde Femoral Nail is indicated for internal fixation and stabilization of the femur. These devices are implanted by insertion into the medullary canal of the femur for fixation of open and closed acute distal femoral fractures, pathological fractures, malunions, nonunions, failed plate/screw osteosyntheses of the distal femur, fractures proximal to a total knee arthroplasty, fractures distal to a total hip prosthesis, and fixation of a surgically prepared femur (osteotomy) for correction of deformity.

Femoral nails are to be used for treatment of fractures of the femur including: non-I enoral natis and comminuted mid-shaft fracture, subtrochanteric fracture, distal third comminuted and commination mid bither fransal neck, intertrochanteric fracture, fracture, combination fractures of the mochanteric fractures. Other indications include: combination interactive procedures following tumor resection, and revision procedures where other treatments or devices have failed.

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These 13 mm diameter nails have the same intended use, warnings and precautions as those nails previously cleared in K982953. A new 13 mm size is being added in 20cm, 24cm, 28cm, 32cm, 34cm, 36cm, 38cm, 40cm and 44cm lengths to expand the product line. The 13 mm diameter is larger than the retrograde style nails previously cleared.

This appears to be a 510(k) premarket notification for a medical device, specifically a Titanium Retrograde Femoral Nail. The provided documents describe the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way that would be relevant for a machine learning or diagnostic device.

The 510(k) pathway for traditional medical devices (like this intramedullary nail) typically relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new performance studies with acceptance criteria in the same manner as a novel diagnostic or AI device. The "Summary of Safety and Effectiveness" here focuses on the material, design similarity, and intended use compared to existing devices.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable to the provided text. I will address each point based on the information available and note when information is not present or not relevant to this type of submission.

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

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. This submission relies on substantial equivalence to a predicate device rather than a new clinical performance study with a test set. There is no new data provenance or sample size reported for the performance of this specific device model.

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. Ground truth assessment by experts for a test set is not part of this 510(k) submission type. The "ground truth" for predicate devices is established through their long-standing use and clinical acceptance over decades.

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

Not applicable. There is no test set or adjudication process described in this submission.

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 is a medical implant, not an AI or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This is a medical implant, not an algorithm.

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

For the predicate devices, the "ground truth" for safety and effectiveness is implicitly established through decades of clinical use and physician experience with intramedullary rods for fracture fixation. No specific new ground truth for this device is established beyond its material and design similarity to existing devices. The submission states, "This device utilizes standard technology that is commonly known by physicians."

8. The sample size for the training set

Not applicable. This is a medical implant, not a machine learning model.

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

Not applicable. This is a medical implant, not a machine learning model.

Summary of Device and Approval Context:

The Titanium Retrograde Femoral Nail - 13 MM Diameter is an intramedullary rod used for internal fixation and stabilization of the femur in various fracture scenarios. The 510(k) clearance (K013923) was granted based on the device's substantial equivalence to previously cleared Biomet Titanium Intramedullary Nails (K982953), which themselves were equivalent to devices commercially available since the 1950s. This means the device met the regulatory requirements by demonstrating that its technology, intended use, and fundamental safety and effectiveness profiles are similar to devices already on the market. The FDA determined that no new premarket approval application (PMA) was required because the device does not raise new questions of safety and effectiveness.

Ask a specific question about this device