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The AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

The AOS Proximal Tibia Plating System consists of precontoured, single use, open reduction internal fixation Lateral Proximal Tibia Plates and Posteromedial Proximal Tibia Plates, manufactured from titanium alloy, and AOS Fibonacci screws 3.5mm in diameter or larger. These plates and screws, and their dedicated accessories and sterilization trays, will be added to the AOS Fibonacci Lower Extremity Plating System. The 4.0mm Fixed Angle Locking Screws are single use titanium alloy orthopedic fixation screws, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. The 3.5mm Diamond Workhorse Screws are single use titanium alloy orthopedic fixation screws with a faceted cut core diameter, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test. It generally refers to "the AOS Proximal Tibia Plating System" being subjected to various tests. The data provenance is not specified (e.g., country of origin). The testing described is prospective as it was conducted to demonstrate substantial equivalence for a new device submission.

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

Not applicable. This device is a metallic bone fixation appliance, and the "ground truth" is established through mechanical and engineering performance testing, not through expert human assessment of images or clinical outcomes in the same way an AI diagnostic device would be.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on objective mechanical testing against established standards (ASTM F382, ASTM F543) rather than human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers' performance is being evaluated with and without AI assistance. This document describes a medical device (bone plating system) where performance is assessed through physical and mechanical testing.

6. 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. The document describes the mechanical performance of a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by the performance requirements outlined in the referenced ASTM standards (ASTM F382 for static and fatigue bending, and ASTM F543 for torsion, insertion torque, and pullout strength). The performance of the predicate devices, which are legally marketed, also serves as a benchmark for "ground truth" in the substantial equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.

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

Not applicable. There is no training set for this type of device.

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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 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.

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The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

The AOS Calcaneal Plating System consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.

This document describes the regulatory submission for the AOS Calcaneal Plating System (K182466). Due to the nature of the device (a metallic bone fixation appliance), the acceptance criteria and supporting study are primarily focused on mechanical performance and substantial equivalence to predicate devices, rather than the performance of an AI or software algorithm.

Here's an analysis of the provided information, addressing your questions to the extent possible given the context:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical "acceptance criteria" in a table format for specific performance metrics. Instead, the demonstration of equivalence relies on comparative mechanical testing and engineering analysis against a predicate device.

The submission states: "The results demonstrate that the AOS Calcaneal Plating is substantially equivalent to the predicate."

An "Engineering analysis” was also used to demonstrate substantial equivalence to the AOS Small Fragment Plating System Lite (K181035). While specific numerical results are not provided in this summary, the conclusion is that the performance testing and engineering analysis "demonstrated that the subject device had substantially equivalence performance." |
| Similar Indications for Use: The device must have the same or similar intended use as the predicate. | The indications for use are stated as: "fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone." The submission states, "The proposed system has the same indications for use..." |
| Similar Design and Fundamental Technology: The device must share similar design features and fundamental technological principles with the predicate. | The submission states: "The proposed system... is similar in shape and design, and has the same fundamental technology."

Similarities to predicates include:
• Same device classification
• Same cross sectional area
• Same thickness
• Same hole features |

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

• Test Set Sample Size: The document mentions "A worst case sample" was tested for the four-point bend test. This implies a very limited sample size, likely representative pieces or configurations rather than a large statistical sample of patient data. Specific numbers are not provided.
• Data Provenance: The mechanical testing data would be generated in a laboratory setting, likely in the US, given the submission is to the FDA. This is not patient data, so "retrospective or prospective" does not apply in the typical clinical sense. It is pre-clinical data.

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

This concept of "ground truth" established by experts typically applies to AI/software performance where human consensus or pathology reports define the correct output. For a mechanical device, the "ground truth" is established by recognized engineering standards and validated testing methodologies.

• No human experts were used to establish "ground truth" for the mechanical performance of the device in the way a radiologist would for an image. The "ground truth" is defined by the objective physical properties and mechanical behavior measured according to the standard.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies, typically in AI studies. For mechanical testing, the results are quantitative measurements against an engineering standard.

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

No. An MRMC study is relevant for assessing human reader performance, usually with AI assistance. This submission is for a medical device (bone plate) and does not involve AI or human readers interpreting data.

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

No. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is defined by:

• Engineering Standards: Specifically, ASTM F382-17 (Standard Specification for Metallic Bone Plates).
• Predicate Device Performance: The mechanical performance of the legally marketed predicate device (Synthes Modular Mini Fragment LCP System) served as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an AI model. This submission is for a physical medical device.

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

Not applicable, as there is no AI training set.

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The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.

The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.

The provided text describes a medical device, the "AOS Small Fragment Plating System Lite," and its clearance process (K181035) by the FDA. However, this document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it details a traditional 510(k) submission for a physical medical device (bone plating system) where substantial equivalence is demonstrated through preclinical testing (mechanical strength, material properties) and comparison to predicate devices, rather than AI performance metrics.

Therefore, I cannot fulfill your request for all the specified information as it pertains to an AI device's acceptance criteria and study.

What can be extracted from the document related to "acceptance criteria" (understood as performance standards for this physical device) and "studies" (preclinical testing):

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

2. Sample sized used for the test set and the data provenance: Not applicable. This is preclinical physical testing, not a clinical study involving a test set of data. The devices themselves are the "samples" for mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through standardized testing protocols (e.g., ASTM standards) and engineering analysis, not expert medical consensus.

4. Adjudication method 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. This is for a physical orthopedic implant, not an AI diagnostic or assistance 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: For the mechanical properties, the "ground truth" is defined by the physical laws and material science principles measured by validated test methods (ASTM standards) and engineering calculations.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary of Preclinical Testing Mentioned:

• Type of Study: Preclinical mechanical testing and engineering analysis.
• Purpose: To demonstrate substantial equivalence of the AOS Small Fragment Plating System Lite to predicate devices in terms of mechanical performance.
• Methods:
  • ASTM F382 Static and dynamic four-point bend testing for plates (bending strength and stiffness).
  • Engineering analysis for screws (torsional strength, bending strength, and axial pullout strength).
  • Comparison to predicate devices (Synthes One Third Tubular Plate K011335, Small Fragment Dynamic Compression Locking (DCL) System K000684, AOS Small Fragment Plating System K161913).
• Conclusion: The device was found to have substantially equivalent bending strength and bending stiffness for plates, and substantially equivalent performance in torsional strength, bending strength, and axial pullout strength for screws through engineering analysis. This demonstrated that the device "does not raise any different questions of safety or effectiveness" compared to the predicates.
• Clinical Data: "There is no clinical data referenced in this 510(k)."

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The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.

The provided text describes a medical device, the "AOS Anterolateral Proximal Humeral Plate," which is a metallic bone fixation appliance. The document is a 510(k) premarket notification for modifications being added to the existing system. Crucially, the document explicitly states under the "CLINICAL DATA" section: "There is no clinical data referenced in this special 510(k)."

This means that no clinical study was conducted as part of this specific 510(k) submission to prove the device meets acceptance criteria. The claim of substantial equivalence for the modifications (adding 16 and 18-hole plates) is based on similarities to predicate devices and preclinical testing (though the document states mechanical testing was not necessary due to no anticipated decrease in strength or increase in risk).

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this specific submission because the document explicitly states no clinical data was referenced.

The relevant information is:

• Acceptance Criteria and Reported Device Performance: Not applicable, as no clinical study was referenced for this submission. The submission relies on substantial equivalence to predicate devices and the absence of a need for new mechanical testing for the additions.
• Sample size for test set and data provenance: Not applicable, as no clinical study was referenced.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No, not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as no clinical study was referenced.
• How the ground truth for the training set was established: Not applicable.

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The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

The AOS Small Bone Nail is a titanium alloy (Ti-6Al-4V) intramedullary nail available in various lengths (110mm to 260mm) and diameters (2.5mm to 5.0mm). The nail is compatible with use of 3.5mm and 2.7mm cortical locking screws that allow for additional fracture fixation and locking capabilities.

The provided text describes a 510(k) premarket notification for the "AOS Small Bone Nailing System." A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than strictly proving a device meets predefined acceptance criteria through a study with outcome measures. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) is not directly applicable or provided in this type of regulatory document.

However, based on the information provided, I can construct a table and address the other points within the context of a 510(k) substantial equivalence submission.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) for a medical device like an intramedullary nail, "acceptance criteria" and "device performance" primarily relate to demonstrating mechanical equivalence to a predicate device and fulfilling the same indications for use.

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

• Sample Size for Test Set: The document mentions "comparative mechanical testing per a four point bend test based on ASTM F1264-14." However, it does not specify the exact sample size (number of nails tested) for this mechanical test.
• Data Provenance: The data is from preclinical testing performed by the manufacturer, Advanced Orthopaedic Solutions, Inc. (AOS). This is not clinical data from patients. The country of origin for the data is not explicitly stated beyond being conducted by AOS, which is based in Torrance, California, USA. It is inherently prospective data, as it was generated specifically for this regulatory submission.

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

This information is not applicable and not provided in the document. The device in question is a medical implant (intramedullary nail), and the "ground truth" for its mechanical performance is established through standardized engineering tests, not expert human assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions or diagnoses. Mechanical testing does not involve such adjudication.

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. The device is an intramedullary nail, not an AI or imaging device that would involve human readers or AI assistance. No MRMC study was conducted or referenced.

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

This is not applicable. The device is a surgical implant, not an algorithm or AI system. Its performance is assessed through mechanical properties and clinical outcomes (which are not presented here, as the submission states "No clinical data referenced").

7. The Type of Ground Truth Used

The "ground truth" for the device's performance in this context is the results of standardized mechanical testing (four-point bend test based on ASTM F1264-14), which assesses physical properties like strength and flexibility. The intended use and material composition also serve as "ground truths" in the demonstration of substantial equivalence to predicate devices.

8. The Sample Size for the Training Set

This is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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