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These devices are indicated for the following:

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 and malunions, bone reconstruction following tumor 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

Not Found

This 510(k) uses a "substantial equivalence" approach rather than performance criteria based on clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted directly from this document.

Here's what can be provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or reported device performance in a typical clinical study format. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "acceptance criteria" are effectively the characteristics that demonstrate this equivalence.

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

Not applicable. This is not a clinical performance study with a test set of patient data. It's a submission for substantial equivalence based on technical and functional similarities to predicate devices.

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

Not applicable. No ground truth was established by experts for a test set in this context.

4. Adjudication method 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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable.

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The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

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

1. The Nail Implant is an expandable, sealed, stainless steel, cylindrical, ribbed rod without interlocking holes. The proximal end has a one-way valve for expansion. The nail is cap protected.
2. The Insertion Handle is a device designed to be connected to the nail proximal end, and used for nail insertion. Its distal end has locking "teeth" to prevent relative rotation between the nail and the handle.
3. The Inflation Device is a pump, which rotation of its handle delivers saline into the nail. The pump pressure gauge indicates the expansion pressure. This action causes the nail expansion and abutment to the bone medullary cavity.
   In addition the system consists of additional accessories including a removal adapter, a slide hammer and a slide hammer adapter and a screwdriver.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Fixion Intramedullary Nailing System:

This document is a 510(k) premarket notification for a medical device. FDA 510(k) clearances typically rely on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria and performance metrics against a robust ground truth, as would be common for AI/ML-based software. Therefore, many of the requested categories are not applicable to this type of submission.

The "acceptance criteria" here are primarily about meeting existing material and handling standards and demonstrating similarity to already-cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable to this 510(k) submission. There is no "test set" in the context of an algorithm or diagnostic performance evaluation described. The submission focuses on demonstrating compliance with material standards and substantial equivalence to existing devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. No ground truth for a test set (in the context of diagnostic accuracy or AI performance) was established or is relevant to this type of device submission.

4. Adjudication Method for the Test Set

This information is not applicable. No test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This is a physical medical device (intramedullary nail), not a diagnostic algorithm or AI-assisted system where human reader performance would be a relevant metric.

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

No, a standalone performance evaluation (as would be done for an algorithm) was not done. This device is a surgical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The primary "ground truth" for this submission would be:

• Engineering Standards: Conformance to established ASTM and ISO standards for materials (e.g., 316L stainless steel meeting F138).
• Predicate Device Characteristics: The characteristics (intended use, operating principles, design, materials, packaging, sterilization) of the previously cleared Fixion IM Nailing System (K990717, K003212, K003215, K010901) and Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967). The new device's characteristics are compared against these known, legally marketed devices.

There is no "ground truth" related to disease pathology or patient outcomes in this particular 510(k) submission beyond the general safety and effectiveness implied by equivalence to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an algorithm or AI system for a physical medical device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As there is no training set, there is no method for establishing its ground truth.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Fixion™ Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.

The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.

• The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
• The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid.
  The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device.
• The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector.
  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.

The provided text describes the "Fixion Intramedullary Nailing System," a medical device for fixing long bone fractures. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the way envisioned by the prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement with AI).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with performance metrics.

Here's an analysis of why the requested information cannot be fully extracted and what is available:

The document provides details typical for a 510(k) submission, including:

• Intended Use: Fixation of long bone fractures (humerus, femur, tibia).
• Predicate Devices: Several existing intramedullary nails.
• Performance Standards (for materials and mechanical testing): ASTM F138 (stainless steel), ASTM F1264 (4-point bending), ASTM F383 (torsional testing). These are material and mechanical integrity standards, not clinical performance acceptance criteria.
• Substantial Equivalence: Claims equivalence in intended use, indications for use, materials (Stainless Steel 316L canulated design), and fixation mechanism (expansion of nail vs. distal locking mechanisms of predicates).
• Testing mentioned: "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." However, no specific details on these studies, their methodology, acceptance criteria, or results are provided in this summary.

Therefore, I cannot populate the requested table and answer many of the questions as the document does not contain acceptance criteria related to a device's clinical performance (e.g., diagnostic accuracy, effectiveness in human-AI collaboration) or a study proving it meets such criteria.

The prompt seems to be expecting information typically found in submissions for AI/ML-driven diagnostic devices, which require studies to demonstrate performance against clinical endpoints or expert ground truth. This document is for a mechanical orthopedic implant.

If I were to interpret "acceptance criteria" very broadly as "meeting the requirements for market clearance," then the evidence is the FDA's 510(k) clearance itself, based on substantial equivalence. However, this doesn't align with the detailed performance metrics and study design questions in your request.

Based on the provided text, I can state the following:

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

• Acceptance Criteria: The document mentions adherence to ASTM F138, ASTM F1264, and ASTM F383 for material and mechanical properties. The ultimate "acceptance" criteria for market clearance under 510(k) is demonstrating substantial equivalence to predicate devices in terms of intended use, technology, and safety/effectiveness. No specific performance metrics (e.g., fracture healing rates, reduction in non-union) or acceptance thresholds for such metrics are provided.
• Reported Device Performance: The document states, "The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies." It also claims mechanical equivalence to predicate devices ("equivalent in mechanical properties," "equivalent fixation"). Specific numerical performance data or results from these studies are not provided in this summary.

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 refers to "in-vitro and animal studies" but gives no details on sample sizes, study design (retrospective/prospective), or data provenance. There's no mention of a "test set" in the context of clinical data or AI model evaluation.

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 studies involving human interpretation or AI model validation against expert ground truth, which is not described here.

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

• Not applicable / Not provided.

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 orthopedic 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 / Not provided.

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

• Not applicable / Not provided. For the in-vitro and animal studies mentioned, "ground truth" would likely refer to engineering measurements (e.g., stress/strain, torsion resistance) and animal outcomes (e.g., bone healing, implant stability), but no specifics are given.

8. The sample size for the training set:

• Not applicable / Not provided. This concept (training set) is relevant for AI/ML models, not for an orthopedic implant described in this manner.

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

• Not applicable / Not provided.

In summary, the provided document is a regulatory submission for a medical device (an intramedullary nailing system) focusing on demonstrating substantial equivalence to predicate devices, rather than a clinical study report with detailed performance metrics and acceptance criteria for a diagnostic or AI-driven aid.

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