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The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:

• · Intertrochanteric and subtrochanteric fractures
• · Segmental fractures
• Comminuted fractures
• Pathological fractures
• · Fractures with bone loss
• · Pseudoarthrosis, non-union, mal-union, and delayed union
• · Surgically created defects such as osteotomies

The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:

• . Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
• Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
• Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
• Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.

This document describes the Pro-X1™ Trochanteric Nailing System, a device for fracture fixation in the femur. However, the provided text does not contain the kind of information that would be used to assess the performance of an AI/ML medical device, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies.

The document is a 510(k) summary for a physical medical device (an intramedullary rod system), not an AI/ML-driven diagnostic or prognostic tool. The performance data presented refers to non-clinical bench testing for mechanical properties, not clinical accuracy or utility in an AI context.

Therefore, I cannot provide the requested information in the format of AI/ML device performance.

The "acceptance criteria" discussed in the document are about the mechanical performance of the physical device (e.g., fatigue, bending, torque, pull-out strength) and its substantial equivalence to a predicate device based on these mechanical characteristics.

Here’s a summary of what is available in the document, which pertains to a traditional medical device:

Device: Pro-X1™ Trochanteric Nailing System

Intended Use: Fracture fixation in the femur in adults with osteopenia or osteoporosis.

Predicate Device: X-BOLT IM Hip Nail System (K181640)

Reference Device (for comparison, but not direct predicate): Howmedica Osteonics Corp.'s Gamma 3 Nail System (K034002)

Non-Clinical Performance Data (Bench Testing):

Substantial Equivalence Conclusion: The Pro-X1™ Trochanteric Nailing System is substantially equivalent to the X-BOLT IM Hip Nail System (K181640) based on:

• Same intended use
• Same fundamental scientific technology
• Similar functional and technological characteristics via similar operational principles
• Evaluation of risk and performance data demonstrating it is as safe and effective for its intended use.

Missing Information (as pertains to AI/ML device assessment):

1. A table of acceptance criteria and reported device performance (in an AI/ML context)
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

This document describes a traditional medical device and its mechanical testing, not an AI/ML product.

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The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:

• Pertrochanteric fractures
• Intertrochanteric fractures
• Comminuted fractures
• Segmental fractures
• Fracture with bone loss
• Proximal and distal fractures
• Non-unions and malunions
• Subtrochanteric fractures(only for long nail: more than 320mm)

Dyna Locking Trochanteric Nail™ is consists of Trochanteric Nail for Femur, Neck Screw, Locking Screw for Distal Fixation, and Caps. Distal end part has hole and slot on the transverse direction for screw fixation. Proximal part is designed for neck screw and quide pin which is for insertion of anti-rotation quide wire. Above Neck screws have two types: built-in wedge wing type and without wedge wing type. A built-in wedge wing Neck screw is used as an assembly, and a without wedge wing can be used alone. A user can select the type of Neck screw according to the condition of the patient. Distal part of trochanteric nail uses the cortical type screws. All implants are single use only.

This document is a 510(k) Pre-market Notification from the FDA, which primarily focuses on establishing substantial equivalence of a new medical device to a previously cleared one. It does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria in the way you've outlined.

Specifically:

• This document describes a medical device (Dyna Locking Trochanteric Nail™) and its intended use, and argues for its substantial equivalence to a predicate device.
• It states that "Mechanical strength evaluations per ASTM F543 and geometrical comparisons to the predicate device demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." This is the extent of the performance testing information provided.

Therefore, most of the information requested in your prompt (detailed acceptance criteria tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this type of FDA clearance letter. These details would typically be found in the full 510(k) submission, which is a much more extensive document but not publicly available in this format from the FDA's website.

Based on the provided document, here's what can be answered:

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

• Acceptance Criteria: The document mentions "Mechanical strength evaluations per ASTM F543" as the basis for evaluation. ASTM F543 specifies mechanical test methods for metallic internal fixation devices. The acceptance criteria would be that the device meets the performance requirements (e.g., strength, stiffness, fatigue life) defined by this standard for intramedullary fixation rods, and that its performance is equivalent to or better than the predicate device.
• Reported Device Performance: The document states: "Mechanical strength evaluations per ASTM F543... demonstrate that the subject device's mechanical performance is substantially equivalent to the predicate device." No specific numerical performance values or detailed acceptance criteria are listed.

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

• Not provided. The document only references "Mechanical strength evaluations per ASTM F543" which implies bench testing on device samples, not studies involving patient data.

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/Not provided. This type of information is relevant for AI/ML device studies involving human interpretation or clinical outcomes, not for mechanical device equivalence assessments.

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

• Not applicable/Not provided.

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 is a mechanical device, not an AI diagnostic device that assists human readers.

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

• No. This is a mechanical device, not an algorithm.

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

• For mechanical testing, the "ground truth" would be the engineering specifications and performance limits defined by the ASTM F543 standard.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device requiring a training set.

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

• Not applicable/Not provided.

In summary, the provided document is an FDA 510(k) clearance letter for a mechanical orthopedic implant, asserting its substantial equivalence to a predicate device based on mechanical testing. It does not involve AI/ML technology or detailed clinical studies with human readers or patient data in the way your prompt describes.

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The Femoral Trochanteric Nail System - Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur.

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Femoral Trochanteric Nail System – Neonail consists of metal rods, bone screws, and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The document is an FDA 510(k) clearance letter for a medical device (Femoral Trochanteric Nail System - Neonail), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's why I cannot fulfill your request completely:

• No acceptance criteria are explicitly stated in a tabular format. The document describes a comparison to a predicate device to establish substantial equivalence, not a set of specific performance acceptance criteria for the new device.
• The document states "Clinical data were not submitted in this premarket notification." This means there was no clinical study conducted on the device to prove it meets clinical acceptance criteria. Instead, the submission relies on non-clinical data (engineering analysis, dimensional analysis, and mechanical testing) to show substantial equivalence.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for a clinical study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone performance study based on clinical data.
• The type of ground truth used from a clinical study.
• Sample size for a training set (as no AI/machine learning component is mentioned or evaluated).
• How ground truth for a training set was established.

However, I can extract the following relevant information regarding the non-clinical data used for demonstrating substantial equivalence:

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

While not in your requested format, the device's performance was evaluated against standards applicable to intramedullary fixation devices. The "acceptance criteria" here are implicitly meeting the requirements of these standards and demonstrating equivalence to the predicate device.

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

• Test Set (Non-clinical): The document refers to "worst case nail" and "worst case screws" being subjected to testing. It doesn't specify the exact number of nails or screws tested beyond referencing "worst case." The data provenance is from non-clinical mechanical testing conducted by the manufacturer (Neoortho Produtos Ortopédicos SA). It is prospective in the sense that the tests were conducted specifically for this submission.

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

• Not applicable. This information pertains to clinical studies, which were explicitly stated as "not submitted."

4. Adjudication Method for the Test Set:

• Not applicable. This information pertains to retrospective clinical studies or expert consensus processes, neither of which were performed for this submission.

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

• No. This type of study involves human readers interpreting cases, often with and without AI assistance, and was not performed.

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

• No. This device is a physical medical implant, not an algorithm. The standalone performance refers to the device's mechanical integrity as tested against industry standards.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is established by engineering and mechanical testing standards (e.g., ASTM F1264, ASTM F384-17, ASTM F543) and a referenced scientific article for cut-out testing (SOMMERS et al., 2004). The "truth" is whether the device meets the physical requirements and behaviors defined by these standards.

8. The Sample Size for the Training Set:

• Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning model.

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

• Not applicable. No training set is involved.

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The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.

The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.

The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.

The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.

The provided text describes the Progen™ Trochanteric Nail System, an intramedullary fixation rod system, and its substantial equivalence with predicate devices. However, this document does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The information provided relates to a traditional medical device (an intramedullary nail system), and the performance data section focuses on sterilization, shelf-life, biocompatibility, and mechanical testing in accordance with ISO and ASTM standards. There is no mention of an AI/ML component, clinical testing, or any metrics related to AI/ML device performance such as sensitivity, specificity, or accuracy.

Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, ground truth, expert qualifications, or MRMC studies based on the provided text.

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The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

The AOS Galileo™ Trochanteric Nail System is a single-use, open reduction and internal fixation device, comprised of the Trochanteric Intermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw, Cortical Locking Bone Screws, and their dedicated accessories, and sterilization trays. The trochanteric nail is a side specific cannulated femoral intramedullary nail with a proximal bend that is designed to enter through the greater trochanter, for the treatment of fractures to the femur, including peritrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations thereof. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed.

This document is a 510(k) summary for the AOS Galileo™ Trochanteric Nail System. It describes the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format as would typically be seen for AI/software-as-a-medical-device (SaMD) performance. Instead, it describes a comparison to predicate devices for mechanical properties.

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

This document does not describe a clinical study with a "test set" in the context of AI/SaMD performance evaluation. The "testing" mentioned is functional and strength comparison analysis of the physical device. Therefore, a sample size for a test set and data provenance for a clinical study are not applicable or provided here.

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

Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires human expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.

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 document pertains to a physical orthopedic implant.

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

Not applicable. This document pertains to a physical orthopedic implant.

7. The Type of Ground Truth Used

For the functional and strength testing, the "ground truth" would be the established mechanical standards and performance characteristics of the predicate devices, against which the new device was compared. This is based on engineering principles and material science, not clinical outcomes or expert consensus in the typical sense for AI.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires a training set.

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

Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes "functional testing and strength comparison analysis" as the study performed to demonstrate that the AOS Galileo™ Trochanteric Nail System is substantially equivalent to its predicate devices. The study concluded that the new device's performance is substantially equivalent, implying it meets the mechanical and functional requirements of the predicate. This is a non-clinical study focused on the physical device's characteristics rather than a clinical trial measuring patient outcomes or an AI model's diagnostic accuracy.

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The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.

The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, refractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.

The ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation. The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.

This document describes the ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System, an intramedullary fixation rod. The information provided is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria for a novel device.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test sets, and ground truth establishment for AI-based devices is not applicable to this submission, as it describes a traditional medical device (hardware) rather than a software or AI-driven diagnostic tool.

The "study" that proves the device meets acceptance criteria primarily refers to mechanical testing to demonstrate the structural integrity and performance of the hardware components.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and 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):

• Sample Size for Test Set: This is not applicable in the context of device hardware mechanical testing. The "test set" here refers to the number of physical device components or constructs subjected to mechanical evaluation. The document does not specify the exact number of implants tested, but rather refers to "components" and "System configuration" being tested according to a standard.
• Data Provenance: The testing is laboratory-based mechanical testing, not clinical data provenance. The device manufacturer is Orthofix Srl, based in Italy.

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 is not applicable. For hardware mechanical testing, the "ground truth" is established by the specified mechanical properties and failure limits defined in the ASTM standard (ASTM F1264-16) and internal test protocols, not by expert human interpretation of data.

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

• This is not applicable. Mechanical testing results are typically objectively measured and compared against defined thresholds from standards or specifications, not subject to human adjudication in the way medical image interpretation is.

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-powered diagnostic devices or software that assist human readers. The ORTHOFIX CHIMAERA Hip Fracture System is a physical implant (hardware). The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

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

• No, this is not applicable. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is based on mechanical engineering principles and established industry standards (specifically ASTM F1264-16). This standard defines the acceptable mechanical properties and failure modes for intramedullary fixation devices. The device's performance is compared against these objective, quantifiable criteria.

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are refined through engineering principles and testing, not machine learning.

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

• This is not applicable. As there is no training set for an AI model, there is no ground truth established in this context.

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The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.

The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.

The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation.
The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.

This document is a 510(k) summary for the Orthofix CHIMAERA Hip Fracture System - Trochanteric Nailing System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For the Orthofix CHIMAERA Hip Fracture System, the acceptance criteria are based on mechanical performance and biocompatibility. The reported device performance indicates that the device met these criteria.

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

The document does not explicitly mention "test set" in the context of clinical trials with human subjects. Instead, it refers to mechanical testing and biocompatibility testing.

• Mechanical Testing: The sample sizes for the mechanical tests (e.g., endurance properties, fracture fixation device testing, intramedullary fixation device testing) are not explicitly stated in the provided text. These tests are performed on device components, not human subjects, so the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not applicable. The tests are conducted in a controlled laboratory environment.
• Biocompatibility Testing: Similar to mechanical testing, specific sample sizes for tests like "Bacterial endotoxin test (LAL)" are not provided. These tests are also laboratory-based.

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

This information is not applicable to this 510(k) submission. This submission focuses on demonstrating substantial equivalence through mechanical and biocompatibility testing, not on clinical performance or diagnostic accuracy that would require expert-established ground truth. There is no mention of a "test set" in the context of expert review for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. As stated above, this submission relies on laboratory-based tests (mechanical and biocompatibility) rather than a clinical "test set" that would involve expert adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

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

This question is not applicable. The device is a hip fracture system (implants and instrumentation), not an AI algorithm or a diagnostic tool. Therefore, the concept of "standalone algorithm performance" is irrelevant.

7. Type of Ground Truth Used

For the mechanical and biocompatibility testing, the "ground truth" is established by the standards and protocols against which the device is tested.

• Mechanical Performance: The "ground truth" is defined by the requirements outlined in standards such as ISO 7206-4, ISO 12107, ASTM F384-12, and ASTM F1264-14. The device is expected to meet or exceed these established performance benchmarks.
• Biocompatibility: The "ground truth" for non-pyrogenicity is defined by the criteria within standards like USP 38: 2014 , USP 38: 2014 , and ANSI/AAMI ST72: 2011.

8. Sample Size for the Training Set

This information is not applicable. The device is a mechanical implant system, not a machine learning model that requires a "training set."

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

This information is not applicable. As the device is not a machine learning model, there is no "training set" or corresponding ground truth to be established in that context.

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The AOS Antegrade and Retrograde Femoral Nail are 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 ioint, nonunions and malunions, fractures resulting from osteoporosis.

The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also intended to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

The AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: transverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intentrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

AOS Nails are intramedullary fixation devices for the temporary fixation of various types of fractures of long bones and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Nail Systems consist of titanium intramedullary nails, proximal and distal locking screws, and end caps.

This Special 510(k) proposes the addition of gamma terminally sterilized nails, screws, and end caps.

This document describes a Special 510(k) premarket notification for AOS Intramedullary Nails, focusing on the addition of gamma terminally sterilized nails, screws, and end caps.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided text does not include explicit acceptance criteria or reported device performance data in the manner typically seen for performance studies of medical devices that generate quantitative results (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific mechanical thresholds for implants tested against an established standard).

Instead, the document asserts substantial equivalence to predicate devices. The basis for substantial equivalence is that "The proposed nails have the same indications for use, geometry and design, have the same fundamental scientific technology, and are made of the same material (Ti-6AI-4V ELI, per ASTM F136) as the predicate nails. As detailed in the submission, the proposed nails only differ in sterilization method, which does not change the safety or effectiveness of the nails."

Therefore, the "acceptance criteria" can be inferred as meeting the criteria for substantial equivalence, primarily demonstrating that the change in sterilization method does not alter safety or effectiveness. The "reported device performance" is the assertion of equivalence to predicate devices, implying that their performance characteristics are maintained.

Inferred Acceptance Criteria:

• Maintenance of indications for use.
• Maintenance of geometry and design.
• Maintenance of fundamental scientific technology.
• Maintenance of material (Ti-6AI-4V ELI, per ASTM F136).
• Sterilization method (gamma terminal sterilization) does not negatively impact safety or effectiveness.

Reported Device Performance (based on substantial equivalence claim):

• The device performs effectively for intramedullary fixation of various long bone fractures, aligning with the predicate devices.
• Safety is maintained with the new sterilization method.

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

• Sample Size for Test Set: Not applicable (N/A). This submission is for a Special 510(k) based on substantial equivalence, not a performance study requiring a test set of data. The "test" is primarily a comparison against existing predicate devices and a justification that the change in sterilization does not alter performance.
• Data Provenance: Not explicitly stated as there is no new performance study with a test set. The data provenance implicitly refers to the information and performance of the established predicate devices, which are already legally marketed.

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

• Not applicable (N/A). No test set requiring expert ground truth establishment for performance evaluation is mentioned in this document.

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

• Not applicable (N/A). No test set or adjudication process is described.

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 device is an intramedullary nail, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

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

• Not applicable (N/A). No new performance study requiring ground truth is described. The "ground truth" for the device's efficacy and safety is derived from the established performance and regulatory clearance of the predicate devices.

8. The sample size for the training set:

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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

• Not applicable (N/A). This document does not describe a machine learning algorithm or a training set.

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The AOS ES™ Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

The AOS ES™ Trochanteric Nail is a Titanium intramedullary nail that is designed to enter the femur through the greater trochanter. It consists of an intramedullary nail. sliding lag screw, anti-rotation screw, locking screws and end cap.

The provided text describes a 510(k) premarket notification for a medical device called the AOS ES™ Trochanteric Nail. This is a submission seeking clearance for a device based on its substantial equivalence to a legally marketed predicate device, not a study proving novel device performance against acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets them for the following reasons:

• Type of Submission: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, not on establishing de novo performance criteria or conducting studies to prove a device meets new performance standards.
• Device Type: The device is an "Intramedullary Fixation Rod" for orthopedic use. Performance is typically evaluated through mechanical bench testing and comparison to existing, already cleared devices, rather than through clinical studies with complex statistical endpoints like those for diagnostic algorithms.
• Content: The summary explicitly states: "Information presented supports substantial equivalence of the AOS ES™ Trochanteric Nail to the predicate device. The proposed nail has the same indications for use, is similar in geometry and design, has the same fundamental technology and is made of the same material (ASTM F136) as the predicate device. The ES Trochanteric Nail was tested against the predicate device through a bench bending analysis as well as a dimensional comparison. The testing resulted in substantial euqivent strength and geometry between the ES trochanteric nail and the short trochanteric nail." This highlights that the "study" was a bench test for equivalence, not a performance study against specific acceptance criteria for aspects like accuracy, sensitivity, or human reader improvement, as would be relevant for a diagnostic or AI-driven device.

Given this, I cannot fill in the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these types of studies and information are not present in the provided 510(k) summary for this orthopedic implant.

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The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings:

• Pertrochanteric fractures
• Subtrochanteric fractures
• Intertrochanteric fractures
• Comminuted fractures .
• Segmental fractures
• Fracture with bone loss
• Proximal and distal fractures
• Non-unions and malunions

The Dyna Locking Trochanteric Nail™ consists of intramedullary rod, neck screw assembly(neck screw + wedge wing), locking screw, fixed nail cap, slidable nail cap, end cap, and short end cap. The rods are available in a variety of diameters and lengths and have holes located at the proximal and distal ends for passing of neck .screw and for fixation to bone by means of locking screws, respectively. The neck screws are inserted into the proximal hole of rod angle with 120, 125, 130, 135 degrees, selectively. The wedge wing in the neck screw prevents the twisting of the neck screw in the femoral head. The fixed & slidable nail cap are fixed in the rod to prevent operation failure due to the excessive motion of neck screw. The fixed nail cap prevents the rotation and movement of neck screw, but slidable nail cap is applicable only for rotation. Meanwhile, the end cap (or short end cap) screws into the threaded end of the nails to prevent bone ingrowth, otherwise newbone in the nail hamper to remove the nail. The end cap is used primarily, however short end cap which do not protruding out of nail also may be used according to patients' conditions. All implants of Dyna Locking Trochanteric Nail " are single use device, supplied non-sterile and manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Trochanteric Nail™

This document describes the Dyna Locking Trochanteric Nail™, an intramedullary fixation system. The testing described is non-clinical (bench testing) to establish substantial equivalence to predicate devices, not a study involving human subjects or AI algorithms. As such, many of the requested categories are not applicable to this submission.

Here's the breakdown of the information provided in the context of your request:

Acceptance Criteria and Device Performance

The submission states that the "testing met all acceptance criteria and verifies that performance of the Dyna Locking Trochanteric Nail™ is substantially equivalent to the predicate devices." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it implies successful comparison to the predicate devices.

Study Details (Not applicable for this type of device and submission)

Given that this is a 510(k) premarket notification for a medical implant and the study described is non-clinical bench testing, many of the requested details about human-in-the-loop performance, AI, and ground truth for clinical data are not present.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing. The document does not specify the number of devices tested for each bench test. Data provenance (country of origin, retrospective/prospective) is not relevant to non-clinical bench testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for clinical or AI studies (e.g., expert consensus on images or pathology results) is not relevant to mechanical bench testing. The "ground truth" for these tests would be the established engineering standards or the performance of predicate devices.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 submission is for a physical medical device, not an AI or imaging diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical AI performance. For bench testing, the "ground truth" is defined by established engineering principles and performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI algorithm.
8. How the ground truth for the training set was established: Not applicable.

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