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The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal. metaphyseal. and distal shaft fractures. closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

This is a 510(k) premarket notification for a medical device, specifically the Affixus Tibial and Antegrade Femoral Nailing System. These notifications are submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device. This document is for a traditional medical implant, not an AI software as a medical device (SaMD).

Therefore, many of the requested fields are not applicable or cannot be extracted from the given text. However, I can provide information based on what is available.

Here's the breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) for a physical medical implant (intramedullary fixation rod), the concept of "acceptance criteria" and "device performance" in the context of an AI/algorithm is not directly applicable in the same way. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "device performance" is demonstrated by meeting the standards and benchmarks set by these tests.

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

Explanation of Performance: The document explicitly states: "The information provided herein demonstrates that: any differences do not raise different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k) submission, achieved by passing the listed non-clinical tests and demonstrating material, design, packaging, and sterilization similarity to predicate devices. The specific values or pass/fail thresholds for each test are not provided in this summary, but the successful submission implies they were met.

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: Not specified in the provided text. For mechanical testing of implants, sample sizes typically adhere to relevant ASTM standards.
• Data Provenance: Not specified in the provided text. These are non-clinical lab tests, so country of origin for "data" is typically the testing lab's location. The tests are prospective in the sense that they are specifically conducted for the 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)

• Not Applicable. This is a physical implant, not an AI/algorithm requiring expert-established ground truth on image data or other patient data. The "ground truth" for these tests are the defined mechanical properties and physical characteristics as per the ASTM standards.

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

• Not Applicable. This is a physical implant. The mechanical tests are objective measurements, not subject to adjudication by human interpreters.

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 for a physical implant. No AI component is mentioned, and therefore, no MRMC study or human reader improvement with AI assistance is relevant.

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

• Not Applicable. This is for a physical implant. No algorithm is mentioned.

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

• Mechanical Test Standards: The "ground truth" for the non-clinical tests are the specified mechanical properties and performance requirements outlined in the referenced ASTM standards (e.g., ASTM F1264, ASTM F543, ASTM F2182, etc.). These standards define acceptable ranges for strength, fatigue, torque, etc., which the device must meet or exceed.

8. The sample size for the training set

• Not Applicable. This is for a physical implant; there is no "training set" in the context of an AI/machine learning model.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary of what the document does indicate for this physical device:

The submission highlights that the Affixus Tibial and Antegrade Femoral Nailing System is deemed substantially equivalent to predicate devices based on:

• Similar indications for use.
• Similar technological characteristics (materials, design features, packaging, sterilization).
• Successful completion of a battery of non-clinical mechanical and MR compatibility tests.

The goal of this 510(k) is to demonstrate that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices. The listed non-clinical tests are the evidence used to support this claim.

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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 Antegrade Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthosis 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 maluions, fractures resulting from osteoprorosis.

The AOS Antegrade Femoral Nail System consists of Titanium Alloy Rods, Screws and End Caps for femur fracture fixation.

This report describes the acceptance criteria and the study conducted to prove that the device, the AOS Antegrade Femoral Nail System, meets these criteria.

Acceptance Criteria and Device Performance

The device is an intramedullary fixation rod for femoral fractures and is deemed substantially equivalent to a predicate device. The acceptance criteria for the AOS Antegrade Femoral Nail System are primarily based on comparative mechanical testing and material equivalence to its predicate device. This is a Class II medical device, and the evaluation focuses on establishing substantial equivalence rather than independent performance metrics defined by specific clinical endpoints in the way some software algorithms might.

Study Details

The study conducted to prove the device meets the acceptance criteria is a preclinical testing program primarily focused on demonstrating substantial equivalence to a legally marketed predicate device. This is typical for a 510(k) submission for this type of device.

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

   • Mechanical Testing: The specific sample sizes for the comparative mechanical testing (per tests based on ASTM F384 and In Vitro testing of accessory screws) are not explicitly stated in the provided text.
   • Cadaver Study: The number of cadavers used in the cadaver study is not explicitly stated.
   • Data Provenance: The studies were conducted by Advanced Orthopaedic Solutions, Inc. and are prospective in nature, as they were performed specifically to support the 510(k) submission for this new device. The country of origin for the data is not explicitly stated but is implicitly the USA, where the company and regulatory body (FDA) are located.

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

   • For a traditional medical device like an intramedullary nail, the "ground truth" is established through engineering and biomechanical principles, standardized testing methods (e.g., ASTM F384), and anatomical studies. It is not typically established by human experts in the same way an AI algorithm's diagnostic performance might be.
   • The "ground truth" for the mechanical testing would be the established performance characteristics of the predicate device and the specified requirements of the ASTM standard. This would be interpreted by engineers and biomechanical testing professionals.
   • For the cadaver study, anatomical "ground truth" would be assessed by medical professionals, likely orthopedic surgeons or anatomists, but the number and qualifications are not specified.

3. Adjudication method for the test set:

   • Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretation of data. For preclinical mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and the comparison against a predicate device or industry standard. There is no explicit mention of an adjudication method in the provided text.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

   • No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed for this device. This type of study is relevant for AI algorithms or diagnostic imaging systems where human readers' performance with and without AI assistance is being evaluated. The AOS Antegrade Femoral Nail System is a physical implant for fracture fixation, not a diagnostic or AI-driven system.

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

   • No, a standalone (algorithm only) performance evaluation was not performed. This term is only applicable to AI/software as a medical device (SaMD), which this device is not.

6. The type of ground truth used:

   • The ground truth used for this device's evaluation is primarily engineering specifications, biomechanical performance data (from standardized tests), and anatomical compatibility assessments derived from a cadaver study.
   • The ultimate ground truth for substantial equivalence is the legally marketed predicate device.

7. The sample size for the training set:

   • This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of its development and evaluation.

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

   • As there is no training set for this type of medical device, this question is not applicable.

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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.

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

• supracondylar fractures, including those with intraarticular extension
• ipsilateral hip/shaft fractures
• ipsilateral femur/tibia fractures .
• femoral fractures in multiple trauma patients .
• fractures proximal to total knee arthroplasty .
• fractures distal to a hip implant .
• fractures in the morbidly obese
• fractures in osteoporotic bone .
• impending pathologic fractures .
• malunions and nonunions

Synthes Retrograde/Antegrade Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail, the nail may be inserted from a retrograde approach or from either a retrograde or antegrade approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression.

This document, a 510(k) summary for the Synthes (USA) Retrograde/Antegrade Femoral Nail System, is a premarket notification for a medical device seeking clearance based on substantial equivalence to previously marketed devices. It does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/software-based devices.

Instead, this document focuses on demonstrating that the new device is "substantially equivalent" to existing predicate devices already cleared by the FDA. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or adjudication methods, as these are not relevant to a 510(k) submission for a physical orthopedic implant like a femoral nail.

Here's an explanation based on the provided text:

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

• Cannot be provided. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity) for a software or AI device. The "acceptance criteria" for a 510(k) submission for a physical device like a femoral nail are around demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical properties.
• Reported device performance: The document states "Documentation is provided which demonstrates that the Synthes Retrograde/Antegrade Femoral Nail System is substantially equivalent* to other legally marketed devices." This "performance" is about meeting the FDA's criteria for substantial equivalence, not clinical or algorithmic performance metrics.

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. This pertains to studies for software or AI performance. For a physical device like a femoral nail, typical testing might involve mechanical bench testing, but the document does not provide details of such tests, their sample sizes, or data provenance. The assessment here is primarily regulatory based on equivalence.

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 establishment for a diagnostic or AI algorithm is not part of this type of 510(k) submission for a physical orthopedic implant.

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

• Not applicable. This relates to expert review for AI/software performance, not a physical device 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 applies to AI-assisted diagnostic or decision support systems.

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

• Not applicable. This applies to AI/software performance.

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

• Not applicable. This relates to AI/software performance evaluation. The "ground truth" for a physical device is generally its conformity to design specifications and mechanical properties, demonstrated through engineering tests and material analyses, which are not detailed here beyond the claim of substantial equivalence.

8. The sample size for the training set

• Not applicable. This applies to AI/software development.

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

• Not applicable. This applies to AI/software development.

In summary, the provided document is a 510(k) summary for a physical medical device (a femoral nail system), seeking market clearance based on substantial equivalence to existing devices. It does not contain the type of performance evaluation data (acceptance criteria, study details, expert review, AI performance metrics) that would be found in a submission for a software or AI-driven diagnostic device.

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The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.

Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):

• Open and closed femoral and tibial shaft fractures .
• Pseudoarthrosis and correction osteotomies .
• Pathologic fractures and tumor resections .
• Change of procedure following external fixation .

Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):
The Osteo R/A Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may 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 intra-articular extension .
• Ipsilateral femur fractures .
• Fractures proximal to a total knee arthroplasty ●
• Fractures distal to a hip implant .
• Nonunions and malunions ●

This submission involves no change to the components themselves. This submission covers use of predicate T2 Locking Screws with predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems.

The provided text describes a 510(k) premarket notification for T2 Locking Screws intended for use with existing Osteo Femoral and Tibial Nails. This is a medical device submission, and the focus of the documentation is on demonstrating "substantial equivalence" to predicate devices, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way a new drug or novel medical AI would.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as they relate to AI/software performance rather than a hardware modification being compared to predicate devices. The study here is an engineering analysis and mechanical testing study, not a clinical or AI performance study.

Here's the information that can be extracted and how it relates to the provided context:

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

For a device modification like this, the "acceptance criteria" are typically defined by demonstrating that the modified device performs at least as well as, or equivalently to, the predicate device in key functional areas, often through mechanical testing to ensure structural integrity and proper fit. The document explicitly states:

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

This information is not provided in the excerpt. For mechanical testing, the "sample size" would refer to the number of devices tested. Data provenance (country, retrospective/prospective) is typically not relevant for mechanical engineering tests of medical hardware.

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. Ground truth is not established by human experts in the context of mechanical testing for substantial equivalence. The "ground truth" for such a device is established by engineering specifications, material properties, and mechanical performance metrics.

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

This is not applicable. Adjudication methods are used in clinical trials or AI performance evaluations, not typically in mechanical testing for a hardware modification.

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 is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which is beyond the scope of this medical device submission for mechanical hardware.

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

This is not applicable. Standalone performance refers to AI algorithm performance, which is not relevant to this hardware device.

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

The "ground truth" in this context is based on engineering specifications, material science principles, and mechanical test results (e.g., tensile strength, fatigue life, torsional resistance) that demonstrate the T2 Locking Screws perform equivalently or acceptably when used with the specified nail systems compared to the original locking screws.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a hardware modification submission.

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

This is not applicable as there is no training set.

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The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

• . Open and closed femoral fractures.
• . Pseudarthrosis and correction osteotomy.
• . Pathologic fractures, impending pathologic fractures, and tumor resections.
• . Supracondylar fractures, including those with intra-articular extension.
• . Ipsilateral femur/tibia fractures.
• . Fractures proximal to a total knee arthroplasty.
• . Fractures distal to a hip implant.
• Nonunions and malunions. .

The nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.

This appears to be a 510(k) summary for a medical device (Osteo IC Retrograde/Antegrade Femoral Nail - Accessories), specifically focusing on a nut and washer component.

Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity, or any clinical outcomes). The document is a premarket notification for substantial equivalence, which primarily addresses device design, materials, and intended use in comparison to a predicate device.

Let's break down why the requested information cannot be provided from this text:

1. A table of acceptance criteria and the reported device performance: This document explicitly states, "The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail." Substantial equivalence is the pathway being used here, not a performance study against predefined criteria. No performance criteria (e.g., strength, durability, biocompatibility) or reported performance against such criteria are present in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described. The focus is on demonstrating equivalence based on design and materials.
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, as no test set requiring ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is mentioned.
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 a mechanical orthopedic implant (nut and washer), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for performance evaluation in this document.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

In summary, the provided text is a 510(k) Pre-Market Notification Summary for substantial equivalence of a medical device (an orthopedic nut and washer), not a clinical or performance study report. Therefore, it does not contain the information requested regarding acceptance criteria and device performance studies commonly associated with diagnostic or AI-powered devices. The "proof" here is the assertion of substantial equivalence to a legally marketed predicate device based on design, materials, and intended use, which the FDA has accepted.

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The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

• Open and closed femoral fractures.
• Pseudarthrosis and correction osteotomy.
• Pathologic fractures, impending pathologic fractures, and tumor resections.
• Supracondylar fractures, including those with intra-articular extension.
• Ipsilateral femur/tibia fractures.
• Fractures proximal to a total knee arthroplasty.
• Fractures distal to a hip implant.
• Nonunions and malunions.

The Osteo IC Retrograde/Antegrade Femoral Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Osteo IC Retrograde/Antegrade Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Osteo IC Retrograde / Antegrade Femoral Nail is available in three versions, each in lengths from 240mm to 500mm in 20mm increments, and in diameters from ø9mm to ø15mm in 1mm increments. A compression screw and locking screw may be used with the Femoral Nail. An end screw and an end cap are also available for use with the Femoral Nail. An end cap or end screw is used if a compression screw has not been used. The end screw is used when the Femoral Nail has been inserted via a retrograde approach. The end cap is used when the Femoral Nail has been inserted via an antegrade approach.

This is a 510(k) premarket notification for a medical device (Osteo IC Retrograde/Antegrade Femoral Nail), not an AI/ML clinical study. Therefore, the requested information about acceptance criteria, study design, and AI/ML specific details is not applicable to this document.

Here's why and what information can be extracted:

• No Acceptance Criteria or Device Performance Study: 510(k) submissions for devices like this typically focus on demonstrating substantial equivalence to a predicate device already on the market, not on conducting a new clinical study with specific performance metrics and acceptance criteria for a novel technology.
• No AI/ML Component: The device is a physical intramedullary nail for fracture fixation. There is no mention of any AI or software component in the submission.
• No "Test Set," "Training Set," or "Ground Truth": These terms are relevant to AI/ML model development and validation. Since this is a physical medical device, these concepts do not apply.
• No "Experts" for Ground Truth (in the AI/ML sense): While medical professionals like surgeons and radiologists use such devices, their role isn't to establish "ground truth" for an AI model's output in this context.
• No "MRMC Comparative Effectiveness Study": This type of study assesses how AI assistance impacts human reader performance, which is irrelevant for a standalone physical implant.

Information that can be extracted from the document (though not matching your specific table format for AI/ML):

Summary of Device and Regulatory Status:

• Device Name: Osteo IC Retrograde/Antegrade Femoral Nail
• Sponsor: Osteonics Corporation
• Submission Date: July 22, 1998
• FDA Decision Date: September 14, 1998
• Regulatory Class: II
• Product Code: HSB
• Predicate Devices: Synthes Titanium Distal Femoral System, Synthes Titanium Unreamed Femoral Nail System, AIM Titanium Femoral Nail (ACE Medical), Richards Retrograde Nail.
• Determination: Substantially Equivalent to predicate devices.
• Device Description: Cylindrical, cannulated titanium alloy tube, slightly bowed, available in various lengths (240mm to 500mm) and diameters (ø9mm to ø15mm). Can be inserted via retrograde or antegrade surgical approaches. Uses locking screws, end caps, nuts, and washers.
• Intended Use/Indications: Long bone fracture fixation, specifically femoral fracture fixation, including:
  • Open and closed femoral fractures
  • Pseudoarthrosis and correction osteotomy
  • Pathologic fractures, impending pathologic fractures, and tumor resections
  • Supracondylar fractures, including those with intra-articular extension
  • Ipsilateral femur/tibia fractures
  • Fractures proximal to a total knee arthroplasty
  • Fractures distal to a hip implant
  • Nonunions and malunions

This document is a regulatory filing for a conventional medical device, not a study report for an AI-powered diagnostic or therapeutic tool.

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