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The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails.

The indications for use of the I.T.S. INS Proximal Femur include:

All Nails:

• · Stable and unstable pertrochanteric fractures
• · Intertrochanteric fractures
• · Combinations of fractures listed above

Additionally for Long Nails:

• Subtrochanteric fractures
• · Proximal fractures as listed above associated with shaft fractures
• · Pathological fractures in regions as listed above
• · Nonunions and malunions in regions as listed above

The I.T.S. INS Proximal Femur Nail consists of the following implants:

1. Nails:
   The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths.

2. Lag Screw
   Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

3. Set Screw
   There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

4. Distal Cortical Locking Screw
   Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

5. Instrumentation
   I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers.

All nails and screws are provided Sterile for single-use.

The provided text describes a 510(k) submission for the I.T.S. INS Proximal Femur Nail. This is a medical device for intramedullary fixation, and the FDA has determined it to be substantially equivalent to previously marketed predicate devices.

However, the text does not include information about AI/ML device performance, acceptance criteria normally associated with diagnostic algorithms (like sensitivity, specificity), or details about studies involving human readers or ground truth establishment relevant to AI. The nature of this submission is for a physical medical device (an intramedullary nail), not an AI-powered diagnostic tool.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document.

Here's a breakdown of what can be extracted from the text, focusing on the mechanical evaluation of the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format typically used for AI/ML performance (e.g., minimum sensitivity). Instead, the performance is evaluated against consensus standards and compared to predicate devices for substantial equivalence.

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

Not applicable. This is a physical medical device, and the testing involved mechanical performance, not a test set of data for an AI algorithm.

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

Not applicable. Ground truth establishment by experts is relevant to AI/ML diagnostic performance, not the mechanical testing of an intramedullary nail.

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

Not applicable. Adjudication methods are relevant to expert consensus for AI/ML ground truth, not mechanical device testing.

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 physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. There is no AI algorithm being evaluated.

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

For the mechanical testing, the "ground truth" or standard for comparison was defined by consensus standards (ASTM F543 & ASTM F1264) and the mechanical performance of predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm with a training set.

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

Not applicable. There is no AI algorithm with a training set or ground truth in this context.

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aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

• Nail in different diameters .
• Interlocking screws in different lenghts ●
• Interlocking nut ●
• Protection cap in different lengths ●
• CondyLock ●
• Accessories, like targeting devices etc. ●

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
• Study Details: Since there's no mention of specific performance testing, there's no information on:
  • Sample sizes for test sets
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • MRMC comparative effectiveness studies
  • Standalone performance studies
  • Type of ground truth used
  • Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

• Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
• Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
• Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
• Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

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The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.

The Fixion Intramedullary Proximal Femoral Nailing System consist of the following main components:

1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg (Hip Peg) and Hip Pin. Other implantable components provided are the Femoral Neck Peg (Hip Peg) and the Hip Pin.

2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the implant.

3. The Inflation Device (Pump) is a single-use manual plastic pump that is filled with sterile inflation liquid and used to expand the Nail implant and Femoral Neck (Hip) Peg

Once the Nail and the Femoral Neck Peg are positioned within the medullary canal and femur neck respectively, rotation of the pump handle allows for peg and nail diameter increase to their intended diameter under x-ray and controlled pressure. The Hip Pin may be inserted as well.

The provided text describes a 510(k) summary for a medical device (Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not available in the given document.

The document primarily outlines:

• The device's description and intended use.
• Its classification and predicate devices.
• The performance standards it meets (primarily ASTM standards for material composition and mechanical testing).
• The claim of substantial equivalence to a previously cleared device (K010988) based on similar intended use, operating principles, design, materials, processes, sterilization, and packaging.

Based on the information provided, here is what can be inferred or stated:

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

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

This information is not provided in the document. The document refers to mechanical testing against ASTM standards, but does not detail sample sizes for these tests, nor does it refer to human clinical test sets.

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

This information is not provided. The assessment relies on engineering and material standards, not expert clinical ground truth from a test set.

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

This information is not provided. Not applicable to the type of data presented (mechanical and material compliance).

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

A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device (an orthopedic implant) which does not involve "human readers" or "AI assistance" in its direct function. The device is a surgical implant.

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

A standalone performance study of an algorithm was not conducted and is not applicable to this device. The device is a physical intramedullary nailing system.

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

The "ground truth" for this device's acceptance is based on:

• Compliance with ASTM material standards (e.g., F138 for stainless steel).
• Compliance with ASTM mechanical performance standards for orthopedic devices (e.g., F1264-99 for intramedullary fixation, F384-99 for hip pegs).
• Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on similar design, materials, and intended use.

8. The sample size for the training set

This information is not provided and is not applicable. There is no "training set" in the context of this device's mechanical and material compliance testing or substantial equivalence demonstration.

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

This information is not provided and is not applicable as there is no training set mentioned or relevant for this type of device submission.

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