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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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