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The Atlas™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:

• · Diaphyseal fractures of the humeral shaft
• · Proximal humeral fractures with diaphyseal extension
• · Impending pathologic fractures

The Atlas™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:
. A humeral nail with proximal portals for passage of cortical locking screws and/or Atlas™ Screws. The humeral nail also has distal portals that allow passage of deployable integral talons from within the intramedulary canal. The distal talons may be retracted for removal of the nail is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
· Cortical locking screws will be provided separately. The cortical locking screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
· Atlas™ Screws will be provided separately. The Atlas™ Screws have distal portals that allow the passage of integral talons that can be deployed for additional fixation and stability.
· A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail. The proximal end cap also comes in a locking version which includes a distal shaft that locks the cortical locking screw or Atlas™ screw placed in the most proximal portal.
ODI-NA will manufacture the implant grade titanium alloy (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

This document is a 510(k) premarket notification for the Atlas™ Humeral Nail System. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device through non-clinical testing. It does not describe an acceptance criteria or a study that proves a device meets an acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot provide the requested information. The prompt asks for details related to AI/ML device testing, such as sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, and training set information. These concepts are not relevant to the provided 510(k) summary for a traditional orthopedic implant.

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The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:

• A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
• A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
  ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.

This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).

Here's what can be extracted and what cannot:

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

Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.

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 / Not provided. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.

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

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical device.

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 / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.

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

• Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.

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

• For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
• For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.

8. The sample size for the training set

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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The Talon™ DistalFix™ Humeral Nail System is indicated to aid in the alignment and stabilization of humeral fractures, including:

• Diaphyseal fractures of the humeral shaft

• · Proximal humeral fractures with diaphyseal extension
• · Impending pathologic fractures

The Talon™ DistalFix™ Humeral Nail System is used to aid in the alignment and stabilization of humeral fractures. The system consists of the following parts:

• A humeral nail with proximal portals for passage of cortical locking screws ● and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.
• Cortical locking screws will be provided separately. The cortical locking . screws have a reduced minor diameter at the tip which provides increased purchase in cancellous bone by increasing the thread height and are provided for proximal fixation if desired.
• A proximal end cap will be provided separately. The end cap prevents ● bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
  ODi-NA will manufacture the implants from implant grade titanium alloy.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called the "Talon™ DistalFix™ Humeral Nail."

This document primarily focuses on demonstrating substantial equivalence of the humeral nail to a predicate device based on design, materials, manufacturing, sterilization, and mechanical testing. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria, study performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions related to the acceptance criteria and study that proves an AI/ML device meets those criteria.

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

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

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

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

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

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

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

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

The document states:

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

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

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

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The Talon™ DistalFix™ Proximal Femoral Nail's primary indications are for the fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The Talon™ DistalFix™ Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts:

• . A femoral nail with a proximal portal for passage of a lag screw and distal portals that allow passage of deployable intearal talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons, distal end cap and integral lock screw subassembly already installed.
• . A Talon™ lag screw with proximal portals for passage of deployable talons to increase the purchase of the lag screw within the femoral neck/head. These talons may also be retracted for removal of the lag screw if and when it is necessary. The lag screw is cannulated and keyed with tapered flats on the distal This keyed shaft allows the option of static, compression, or axial end.
• A proximal end cap will be provided separately. The end cap prevents bony . ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.
  ODi-NA will manufacture the implants from implant grade titanium allov.

This document does not describe acceptance criteria, performance data, or a clinical study for the device. Instead, it is a 510(k) summary and an FDA clearance letter for the "Talon™ DistalFix™ Proximal Femoral Nail System."

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a new clinical trial with specific performance metrics.

The document states:

• "Review of the mechanical test data indicates the Talon™ DistalFix™ Proximal Femoral Nail is substantially equivalent to the previously cleared ODi nails (K033286 and K014189)." This suggests that mechanical testing was performed to demonstrate that the new device performs similarly to predicate devices, but it does not provide specific acceptance criteria or reported performance values.
• Predicate Devices: The submission relies on substantial equivalence to the Stryker® Gamma3™ Nail System (K043431, K034002, K032244), Orthopedic Designs (ODi) Talon™ Intramedullary Hip Nail (K014189), and Orthopedic Designs (ODi) Talon™ Long Proximal Femoral Nail System (K033286). The assumption is that since these predicate devices are already cleared, and the new device is substantially equivalent, it also meets appropriate safety and performance standards.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of information is generally NOT required or provided in a 510(k) summary for a substantial equivalence determination based on predicate devices and mechanical testing, unless there are unique technological characteristics or new indications for use that warrant clinical data.

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