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These devices are indicated for the following:

Hip:

• femoral head/neck fractures or non-unions;
• aseptic necrosis of the femoral head/neck; and
• osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement

Femur:

• fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
• use in osteotomy, nonunions, bone reconstruction following turnor resection, grafting and pathological fractures, and revision procedures in the femur;
• mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
• comminuted shaft fractures:
• fixation of short distal or proximal fragments

Tibia:

• diaphyseal shaft fractures in the tibia:
• comminuted shaft fractures;
• fixation of short distal or proximal fragments

Humerus:

• diaphyseal shaft fractures in the humerus;
• comminuted shaft fractures;
• fixation of short distal or proximal fragments

The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems.

The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified Pump) has the following similarities to that which previously received 510(k) clearance;

• Have the same intended use
• Have the same operating principles
• The Implants and the Instrumentation Set incorporate the same design
• The Implants and the Instrumentation Set incorporate the same materials
• The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.

The provided text describes a 510(k) premarket notification for a medical device, the Fixion Interlocking Proximal Femur Intramedullary Nailing System. This submission focuses on establishing substantially equivalent performance to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a novel clinical study with quantitative performance metrics.

Therefore, the requested information elements related to a study proving acceptance criteria (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable and not present in the provided document.

Instead, the document details the device's adherence to relevant performance standards for materials and care handling, and its similarities to legally marketed predicate devices.

Here's the breakdown of what can be extracted from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Have the same intended use.
• Have the same operating principles.
• The Implants and the Instrumentation Set incorporate the same design.
• The Implants and the Instrumentation Set incorporate the same materials.
• The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.
  The Inflation Device (Nail Pump/Hip Peg Pump) operates similarly to the pump used with aforementioned Fixion Systems. |

2. Sample size 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 document describes a 510(k) submission based on compliance with existing standards and substantial equivalence to predicate devices, not a clinical study with a test set of patient data.

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 would be relevant for a clinical study assessing diagnostic or therapeutic effectiveness based on expert-adjudicated ground truth. This submission relies on engineering standards and design comparisons.

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

• Not applicable / Not provided. Similar to point 3, this is relevant for studies involving human interpretation or clinical outcomes.

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. This device is an intramedullary nailing system and a hemi-hip system, not an AI-powered diagnostic or assistive tool.

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

• Not applicable / Not provided. This device is a physical implant, not an algorithm.

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

• Not applicable / Not provided. The "ground truth" in this context is adherence to specified engineering material standards (ASTM F 138, ASTM F 565) and functional equivalence to known predicate devices based on design, materials, and intended use.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable / Not provided. As there is no training set, this question is not applicable.

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The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

The Fixion Interlocking Intramedullary 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 interlocking screws to lock the nail in the bone. The Nail Implant may also have both proximal and distal ends with holes for interlocking screws. 2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the Nail Implant. 3. The Inflation Device is a single-use, manual, plastic pump to be filled with sterile inflation liquid. Once the nail is positioned within the medullary canal, rotation of the pump handle allows for nail diameter increase to its intended diameter under x-ray and controlled pressure. Interlocking screws may be used to lock the nail inside the bone.

The provided text K013449 describes the Fixion Interlocking Intramedullary Nailing System. However, this document does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, which is typically associated with AI/ML devices.

Instead, the document focuses on:

• Materials and Mechanical Performance for a physical medical device (an intramedullary nail).
• Substantial equivalence to a predicate device.
• Intended use and system description.

Therefore, I cannot provide the requested information in the format of a diagnostic performance study, as the provided input does not pertain to such a device or study.

Here's a breakdown of why each requested point cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: The document states the device meets ASTM F138 (material spec), ASTM F565 (care/handling), and ASTM F1264-99 (4-point bending mechanical testing). These are standards the device adheres to, not specific performance metrics or acceptance criteria as would be defined for a diagnostic AI model (e.g., sensitivity, specificity, AUC). There are no reported numerical performance metrics from a study in this context.
2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a physical implant, not a diagnostic 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 for a physical implant's mechanical properties is established through material testing and engineering standards, not expert clinical review of data.
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. This is not an AI/ML diagnostic 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 (expert concensus, pathology, outcomes data, etc): For a physical device, the "ground truth" would be adherence to material specifications (ASTM F138) and mechanical performance standards (ASTM F1264-99).
8. The sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional medical device (an intramedullary nailing system) and its compliance with established material and mechanical testing standards, not an AI/ML-driven diagnostic device with associated performance studies.

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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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