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The ODi TALON™ Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi TALON™ Long 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 portals that allow passage of distal cortical screws and a proximal lag screw assembly.
• The TALON™ Lag Screw used in the nail system is completely compatible with ODi's TALON™ Compression Hip Screw system and has been previously approved by the FDA in K984331. The TALON™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments.
• A slotted sleeve which passes through the intramedullary nail. The sleeve is keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw.
• A sleeve lock which passes through the proximal end inner bore of the intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly.
• A compression screw which shoulders against the slotted sleeve and engages the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The cortical screws have been previously approved by the FDA in K984331.
• An end cap with both internal and external threads and a keying slot. The external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation.
• Cortical screws are provided to cross-lock the distal end of the nail to the femoral shaft to help prevent axial translation or rotation of the nail. The cortical screws have been previously approved by the FDA in K984331.

The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery. ODi will manufacture the implants from implant grade stainless steels.

The provided text does not describe a study that proves the device meets specific acceptance criteria.

Instead, the document is a 510(k) summary for the ODi TALON™ Long Proximal Femoral Nail, which is a premarket notification to the FDA. This type of submission aims to demonstrate that a new device is "substantially equivalent" to predicate devices already on the market, rather than proving it meets specific quantitative performance acceptance criteria through a dedicated study.

Therefore, many of the requested information points (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types for training and testing, and training set sample size) are not present in this document.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Indications for Use: What the device is intended to treat.
• Contra-indications for Use: Conditions under which the device should not be used.
• Substantial Equivalence: Listing predicate devices that are similar and already FDA-approved.

The approval letter from the FDA (Pages 3-4) confirms that the device was found substantially equivalent to predicate devices, which is the basis for its market clearance, not a demonstration of meeting specific performance metrics via a clinical or detailed technical study as might be required for a medical imaging AI device, for example.

If this were a submission for an AI/ML medical device, the information requested would be crucial. However, for this orthopedic implant, the provided documentation focuses on substantial equivalence to existing devices.

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The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts:

• Cannulated screws of various lengths, which are positioned through bony fragments to provide stability to the fracture site during healing.
• A washer which provides a bearing surface for the cannulated screw head against the bone. The washer also prohibits migration of the screw head into the cortex.
  ODi will manufacture the implants from implant grade titanium alloys.

The provided text is a 510(k) Summary for the ODi 7.0mm Cannulated Screw System, which is a medical device. This type of document is a premarket notification to the FDA and primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than conducting a detailed performance study with acceptance criteria in the way a diagnostic AI device would.

Therefore, the information required to fill out the table and answer all questions for an AI device's acceptance criteria and study proving its performance is not present in this document.

Here's why and what information is available:

• This is a medical device clearance, not an AI/diagnostic software clearance. The ODi 7.0mm Cannulated Screw System is a physical orthopedic implant (screws and washers for bone fixation). Its "performance" is assessed through manufacturing specifications, material testing, and comparison to predicate devices, not through algorithmic accuracy metrics like sensitivity, specificity, or AUC as an AI diagnostic would be.
• The concept of "acceptance criteria" for this device is related to its physical properties, biocompatibility, and functional equivalence to predicate devices, not a statistical performance threshold.
• There is no "test set," "training set," "ground truth," "experts for ground truth," or "MRMC study" in the context of an AI device. These terms are specific to the validation of AI algorithms.

Therefore, it is not possible to complete the requested table and answer the questions based on the provided text.

However, I can extract the information that is relevant to the document's purpose:

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

• Acceptance Criteria (Implicit - from substantial equivalence): The device must be equivalent to predicate devices in Indications for Use, Device Design, Materials, Method of Manufacture, and Method of Sterilization.
• Reported Device Performance: The document states the device "is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization."

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 is not a study assessing diagnostic performance against a test set.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) 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.

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 (expert consensus, pathology, outcomes data, etc)

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Summary of available information from the document:

• Device Name: ODi 7.0mm Cannulated Screw System
• Indications for Use: Fixation/stabilization of stable fractures of the proximal femur (pertrochanteric, basilar femoral neck, subcapital, and combinations), intercondylar femoral fractures, and tibial plateau fractures until bony union occurs.
• Predicate Devices: Examples include products from aaP Implants, Inc, Advanced Orthopaedic Solutions, DePuy/ACE, Inc., Magly Orthopedics, LLC, and Synthes, Inc. (K990776, K014185, K893512, K021662, K021932, K962011).
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices.

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The ODi Talon™ Intramedullary Hip Nail will be used on indications that are common with presently marketed intramedullary hip nail systems. The primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi Talon™ Intramedullary Hip 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:

• An intramedullary nail with portals that allow passage of distal cortical screws . and a proximal lag screw assembly. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.
• The Talon™ Lag Screw is completely compatible with ODi's Talon™ ● Compression Hip Screw system and has been previously approved by the FDA in K984331. The Talon™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments.
• A slotted sleeve which passes through the intramedullary nail. The sleeve is . keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw.
• A sleeve lock which passes through the proximal end inner bore of the ● intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. The sleeve lock is provided for surgery pre-assembled in the "unlocked" position within the intramedullary nail.
• A compression screw which shoulders against the slotted sleeve and engages . the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. A polyethylene patch is embedded in the threaded portion of the compression screw to prevent rotation of the screw inside the lag screw after the desired amount of compression is reached.. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The compression screw has been previously approved by the FDA in K984331.
• An end cap with both internal and external threads and a keying slot. The . external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. The end cap is provided for surgery pre-assembled in the intramedullary nail.
• Cortical screws are provided to cross-lock the distal end of the nail to the . femoral shaft to help prevent axial translation of the nail. The cortical screws have been previously approved by the FDA in K984331.
  The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.
  ODi will manufacture the implants from implant grade stainless steels.

The provided text is a 510(k) summary for the ODi Talon™ Intramedullary Hip Nail. However, it does not contain any information regarding acceptance criteria, study design, or device performance metrics that would allow for the completion of the requested table and study details.

The document primarily focuses on:

• Regulatory information: Company contact, classification, and device product code.
• Device description: Detailed breakdown of the components of the intramedullary hip nail system.
• FDA clearance: A letter from the FDA stating substantial equivalence to a predicate device.
• Indications for Use and Contra-Indications: Clinical scenarios for which the device is intended and not intended.

To complete the request, information from a performance study demonstrating how the device met specific acceptance criteria would be necessary. This type of information is typically found in design validation or verification reports, which are not part of a standard 510(k) summary provided to the public.

Therefore, I cannot provide the requested table or study details based on the input text.

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The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur. ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration. The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary. The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

The provided text does not describe an acceptance criteria or a study that proves the device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device: the ODi Ultimate Compression Hip Screw.

This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical or scientific studies.

Here's a breakdown of why this information is not present in the provided text, and what is included:

• Acceptance Criteria and Device Performance: The document states, "No performance standards applicable to the fixation bone screw have been established by the FDA." and "However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively)." This is the closest it comes to "acceptance criteria," but these are material specifications, not performance criteria for the device itself. There is no reported device performance data in relation to specific acceptance criteria.
• Sample Size for Test Set and Data Provenance: No test samples or data provenance are mentioned, as no performance study was conducted.
• Number of Experts and Qualifications: Not applicable, as no ground truth establishment through expert review was performed for a performance study.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not conducted or mentioned. The document relies on substantial equivalence.
• Standalone Performance (Algorithm only): Not applicable, as this is a mechanical orthopedic device, not an algorithm.
• Type of Ground Truth: Not applicable, as no performance study was conducted.
• Sample Size for Training Set: Not applicable.
• Ground Truth for Training Set: Not applicable.

What the document does provide in relation to regulatory submission is:

• Device Description: Details on material, design, function, and available sizes.
• Indications for Use: What the device is intended for.
• Contra-indications for Use: When the device should not be used.
• Predicate Devices: A list of previously cleared devices to which the ODi Ultimate Compression Hip Screw is claimed to be substantially equivalent. This is the core of a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
• Material Standards: Conformance to ASTM material standards for the stainless steel used.

In summary, this document is a 510(k) summary for a mechanical device, which relies on substantial equivalence to predicate devices rather than independent performance studies to establish unique acceptance criteria and prove their satisfaction.

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The ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for:

1. Small Hand Bone Fractures
2. Carpal and Metacarpal Fractures
3. Tarsal and Metatarsal Fractures
4. Distal Metatarsal Osteotomies (Austin Chevron, Scarf)
5. Interfragmentary Radius and Ulna Fractures
6. Osteochondral Fractures
7. Intra-articular fractures
8. Arthrodesis of small joints
9. Reconstructive osteotomies in small carpal or tarsal bones
10. Osteochondritis Dissecans
11. Oblique fractures of the fibula
12. Metatarsal osteotomies and other reconstructive surgeries in the foot

The ODi Ultimate Compression Screw™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. The Ultimate Compression Screw System™ consists of three screw components designed to be used as an assembly. The device has been designed to offer a wide range of compression, and screw sizes to address varving fracture and bone fragment geometries. The assembly consists of the following:

• Proximal Screw Component .
• Distal Screw Component .
• Internal Compression Screw t
  The screw components are equivalent in design to currently marketed standard compression bone screws. The thread form and defining screw features conform to ISO 5835, Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread Dimensions.
  Initially, ten screw lengths will be available in 3.5 mm, 4.5 mm and 6.5 mm diameters, offering a range of fracture compression from 14.0 mm to 58.0 mm. The components are self-tapping and are designed to be manually inserted using commonly available (e.g. American Orthopedic) surgical instruments.
  All device components are manufactured from titanium alloy, Ti-6Al-4V, per ASTM F136 and provided in detail as follows:
  Proximal Screw Component
  The proximal screw component is provided in outer diameters of 3.5 mm, 4.5 mm and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation.
  Distal Screw Component
  The distal screw component is provided in outer diameters of 3.5 mm, 4.5 mm, and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation.
  Internal Compression Screw
  The 2.0 mm internal compression screw is designed to seat within the proximal component and thread into the distal component. As the internal compression screw is threaded into the distal screw component, it draws the proximal and distal screw components together, thereby achieving fracture fixation.
  Note that the internal compression screw is designed to universally fit all proximal and distal screw sizes. This gives the system a modularity that allows the surgeon to select the proximal and distal screw combination that best addresses the fracture geometry.

The provided document is a 510(k) Premarket Notification for a medical device, the ODi Ultimate Compression Screw System™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the document does not describe detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way that might be expected for novel or high-risk devices.

Instead, the document focuses on demonstrating that the device is substantially equivalent to existing, approved devices by meeting established material standards and having comparable indications for use.

Here's an analysis based on the information provided and the nature of a 510(k) submission:

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

The document explicitly states: "No performance standards applicable to the fixation bone screw have been established by FDA." Instead, the primary "acceptance criteria" discussed are compliance with established material standards and substantial equivalence to predicate devices.

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

• Not applicable / Not explicitly stated. This document does not describe a clinical trial or a specific "test set" of patient data for performance evaluation in the typical sense for proving efficacy. The assessment relies on engineering adherence to material standards and design equivalence.

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

• Not applicable. There is no "ground truth" establishment in the context of clinical expert review mentioned, as this is a device based on material and mechanical equivalence, not diagnostic accuracy or clinical outcomes based on a "test set." The FDA's review process inherently involves experts (engineers, scientists from the Orthopaedic Device Section), but their role is in evaluating the 510(k) submission against regulatory requirements and predicate devices, not creating ground truth from patient data.

4. Adjudication method for the test set:

• Not applicable. This document does not describe a test set that would require an adjudication method.

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 bone screw, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

• Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The type of ground truth used:

• For the device's design and material, the "ground truth" is established through industry standards and specifications:
  • ASTM F136-84 (for material chemical and mechanical requirements).
  • ISO 5835 (for screw thread form and defining features).
• For indications for use, the "ground truth" is based on the established and approved indications of predicate devices (Acutrak Fixation System, Herbert/Whipple Bone Screw, Universal Compression Screw). The device's indications are stated to be "comparable to those for approved and marketed devices."

8. The sample size for the training set:

• Not applicable. This document doesn't describe a 'training set' in the context of machine learning or deep learning. The device's design and manufacturing rely on established engineering principles and material science.

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

• Not applicable. As above, no training set for an algorithm is described.

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