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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 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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The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.

This document describes a Special 510(k) premarket notification for the AOS Small Fragment Plating System, which is a metallic bone fixation appliance. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, K152732. This submission does not involve an AI/ML powered device, therefore the information requested is not present.

Here's a breakdown of the relevant information from the provided text:

• Device Name: AOS Small Fragment Plating System
• Regulation Number & Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories. Also 21 CFR 888.3040, Smooth/threaded metallic bone fixation fastener.
• Regulatory Class: Class II
• Product Code: HRS, HWC, HTN
• Indications for Use: Fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
• Predicate Device: AOS Small Fragment Plating System (510k): K152732
• Modifications in K161913 (this submission): Longer and shorter plates, shorter screws, and screw cannulation.
• Basis for Substantial Equivalence: The modified device has the same intended use, indications for use, raw material, method of manufacture, design, type of interface, shelf life, biocompatibility, sterilization, packing methods, and physical limitations as the predicate. It also has similar sizes and dimensions.

Information related to acceptance criteria and study for an AI/ML device (which this is not):

The provided document details a mechanical testing study for a medical device (bone plating system), not an AI/ML powered device. Therefore, the specific criteria requested for AI/ML device performance (such as sensitivity, specificity, AUC, etc.) and studies like MRMC comparative effectiveness studies are not applicable and not present in this document.

The "study" described in this document is a pre-clinical mechanical test:

• Preclinical Testing: "The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate."
• Acceptance Criteria & Reported Performance: The document states that the results of the comparative mechanical testing "demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate." It implies that the acceptance criteria were met if the mechanical performance of the modified device was comparable to the predicate device per ASTM F382-14. The specific numerical values for performance are not included in this summary, but the conclusion of substantial equivalence implies they were acceptable.
• Clinical Data: The document explicitly states: "There is no clinical data referenced in this special 510(k)".

Therefore, the requested information for an AI/ML device is not applicable to this submission. This document pertains to a physical medical device (bone plates and screws) and its mechanical performance.

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The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions 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.

The provided text describes a 510(k) premarket notification for the "AOS Anterolateral Proximal Humeral Plate." This document is an FDA letter recognizing the device as substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria or a study proving the device meets those criteria, as these are typically part of a performance study, not a substantial equivalence claim.

Substantial equivalence is established primarily by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate device, or if there are differences, that they do not raise new questions of safety and effectiveness. The document explicitly states: "physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and predicate plates."

Therefore, based on the provided text, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study was not deemed necessary for this 510(k) submission.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on explaining that the new device (AOS Anterolateral Proximal Humeral Plate) is substantially equivalent to a previously cleared predicate device (AOS Proximal Humeral Plate, K080590) because they share the same indications for use, similar geometry and design, fundamental scientific technology, and material.

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The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or non-union of the Clavicle.

The system consists of an intramedullary titanium device and a fully threaded 2.7mm cortical screw for Clavicle fracture fixation.

The provided document is a 510(k) summary for the AOS Clavicle Intramedullary Device. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on preclinical testing.

However, the document does not contain any information about acceptance criteria, device performance metrics, or a study involving human readers or AI algorithms. The "preclinical testing" mentioned is mechanical testing (a four-point bend test) and is used to demonstrate substantial equivalence to a predicate device, not to assess performance against specific clinical acceptance criteria.

Therefore, for the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details, the answer is:

• No information is available in the provided document for these specific requests.

The document is primarily a regulatory submission demonstrating the device's substantial equivalence for market clearance, not a clinical study report with performance metrics for diagnosis or treatment outcomes, nor does it involve any AI component.

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The AOS Small External Fixation System is intended to be used with the AOS External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments.

The AOS Small External Fixation System is intended to be non-weight bearing.

The AOS Small External Fixation System is an external fixation device comprised of rods, clamps, and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The AOS Small External Fixation System is manufactured with threaded half pins and rods of 5.0mm shaft diameter, which allows for connectivity with AOS' External Fixation System (510(k) cleared: K080408) for support with bone fractures. The system is comprised of titanium and stainless steel (pin-to-rod and multi-pin) clamps, stainless steel threaded half pins and k-wires, carbon fiber connector rods, and pin caps. The AOS Small External Fixation System is a non-sterile single use fixation device.

The pin-to-rod clamps are designed to clamp to the 5.0mm carbon fiber rods and to the 2.0mm and 3.0mm stainless steel pins. The multi-pin clamps are designed to stabilize fractures using multiple pins in close proximity to each other. The multi-pin clamps can be used individually or as part of a larger construct.

The stainless steel threaded pins come in thread diameters of 2.0mm and 3.0mm with a 5.0mm shaft diameter. Thread lengths are available in 5mm increments from 10mm to 25mm long. Overall pin lengths of 55mm, 75mm, 100mm and 140mm are available. The stainless steel k-wires are provided in a 1.5mm diameter.

The connecting rods are carbon fiber composite with an diameter of 5.0mm and are in lengths of 50mm, 75mm, 100mm, 125mm, 150mm, 200mm, 250mm, and 300mm.

The surgical technique used for the AOS Small External Fixation System is a standard method used for external fixation and is the same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, two T-wrenches, a drill quide, and drills.

The provided text describes a 510(k) premarket notification for the "AOS Small External Fixation System," a medical device for stabilizing bone fractures. The document is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or not available in this type of submission.

Here's a breakdown of the information that is and is not present, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of acceptance criteria with corresponding performance results. The submission relies on "substantial equivalence" to predicate devices, meaning its performance is considered comparable to already cleared devices based on design and intended use, rather than unique, quantitatively measured performance against specific criteria.

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

Not applicable. No specific test set to measure performance against acceptance criteria is described. The submission focuses on comparison to predicate devices, not de novo performance testing.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set 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

Not applicable. This device is a mechanical external fixation system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

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

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

Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "study" that proves this is primarily a comparative analysis of design features, operating principles, materials, and indications for use between the new device and the predicate devices.

The crucial statement is:

"The construct of the AOS Small External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction, and indications, it was determined that no mechanical testing was necessary to demonstrate substantial equivalence."

This indicates that the FDA accepted the argument that because the device is so similar to existing, cleared devices, specific performance testing to define new acceptance criteria and then meet them was not required in this 510(k) submission. Therefore, the "study" is effectively the documentation and argument for substantial equivalence, which was deemed sufficient by the FDA for clearance.

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