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The Construx External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.

The Construx External Fixation System consists of a central body, and several other components that can be used to create an external fixation frame. These components include:

• Male Stem Assembly
• Aluminum Ankle Assembly
• Carbon Ankle Assembly
• Carbon Straight Clamp Assembly
• Aluminum Male Straight Clamp
• Aluminum Female Straight Clamp
• Aluminum T-clamp
• Aluminum Angular Hinge Clamp
• Aluminum Ring Adapter
  These components can be used with the DFS Bone Screws, and other components of the DFS Standard Fixator, DFS Ring and Vision External Fixation Systems.

The presented document is a 510(k) Summary for the Construx External Fixation System, which is a medical device for bone fixation. The document details the device description, indications for use, and a summary of performance data. However, the available text does not contain the specific acceptance criteria or an in-depth study report that would allow for a detailed answer to all parts of your request regarding AI/algorithm performance.

Here's what can be extracted and inferred from the provided text regarding the device's performance assessment, along with the information that is not present:

Acceptance Criteria and Study for Construx External Fixation System (Non-AI Device)

The Construx External Fixation System is a mechanical device, not an AI/algorithm. Therefore, the questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training data, and expert ground truth for AI models, are not applicable to this document. The "Performance Data" section solely discusses mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The specific numerical values or qualitative descriptions of the acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the exact performance results are not detailed in this summary document. The document only states that the new components met the established criteria.

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

The document states: "Mechanical testing was performed on the Construx External Fixation System. Static and fatigue testing was performed on the new Construx components assembled as external fixation constructs."

• Sample Size for Test Set: Not specified. The number of constructs or individual components tested is not provided.
• Data Provenance: The nature of mechanical testing generally means the "data" is generated in a lab setting, not typically originating from a country or being retrospective/prospective in the way clinical data would be.

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

• This question is not applicable to mechanical testing of a physical device. Ground truth for mechanical testing is based on engineering specifications and physical measurements, rather than expert clinical consensus.

4. Adjudication Method for the Test Set

• This question is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation or clinical data, not for objective mechanical performance.

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

• This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI or imaging diagnostic tool.

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

• This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications and established performance benchmarks derived from the predicate devices. For mechanical testing, this typically involves stress, strain, displacement, and cycle count measurements against pre-defined limits.

8. The Sample Size for the Training Set

• This question is not applicable. Mechanical testing does not typically involve a "training set" in the context of machine learning or algorithms. The "training" for such a device would be the design and manufacturing process, optimized based on engineering principles and prior device data.

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

• This question is not applicable for the same reasons as #8. The "ground truth" for the design and manufacturing would be based on biomechanical principles, material science, and regulatory requirements, informed by the performance of predicate devices.

Summary of Missing Information:

The provided 510(k) summary is a high-level overview. For a comprehensive understanding of the acceptance criteria and study, one would typically need access to the full test report, which would detail:

• Specific test methods (e.g., ASTM standards referenced).
• Exact load conditions, displacement limits, and cycle counts for static and fatigue tests.
• The number of samples tested for each configuration.
• The actual measured performance values compared against the criteria.
• Detailed information about the predicate device's performance data that established these criteria.

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The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The addition of the MAC Male Adapter does not change the indications for use for the MAC External Fixation System.

The purpose of this submission is to add a Male Adapter Assembly to the previously cleared MAC External Fixation System. The subject MAC Male Adapter Assembly is intended to attach to the existing MAC Module), and allows the MAC to connect to other external fixation components, including: Construx Female Telescoping Arm, Carbon T-clamp, the DFS Angular Hinge and the Carbon Ankle component. These connections allow the surgeon to treat a variety of bone conditions amenable to treatment by use of the external fixation modality.

The provided text describes a 510(k) summary for the "MAC External Fixation System," specifically regarding the addition of a "Male Adapter Assembly." The acceptance criteria and supporting evidence are related to the mechanical performance of this new component.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The study described is a mechanical testing study to demonstrate substantial equivalence, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.

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

   • Sample Size: Not explicitly stated in terms of number of constructs tested, but it refers to "assemblies" of the MAC Male Adapter with aluminum and carbon components.
   • Data Provenance: N/A (Mechanical testing, not human data). The testing was conducted internally or by a testing facility as part of the regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth here refers to engineering specifications and performance benchmarks derived from predicate devices, not expert human interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Mechanical testing results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.

4. 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: N/A. This is a mechanical device, not an AI-powered diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a hardware device; there is no algorithm involved.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for performance was established by "pre-established acceptance criteria established by the predicate devices." This implies engineering specifications and performance benchmarks derived from similar, already approved external fixation systems.

7. The sample size for the training set: N/A. This refers to mechanical testing, not a machine learning model.

8. How the ground truth for the training set was established: N/A. No training set is applicable here. The "ground truth" for the mechanical tests was based on performance criteria derived from predicate devices.

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