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The Integra External Fixation System is an external fixation device intended for use 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. Additional indications for the Integra External Fixation System include:

• Correction of deformity
• Revision procedures where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot reconstruction and Lisfranc dislocations
• Ankle distraction (arthrodiastasis)

The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.

The Integra External Fixation System is a medical device and the provided text describes its regulatory clearance, not a study of its clinical performance with acceptance criteria typical for AI/software devices. The information available pertains to the mechanical performance of the device compared to a predicate, not clinical outcomes. Therefore, many of the requested categories for AI/software studies are not applicable.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:

Acceptance Criteria and Study for Integra External Fixation System (K140463)

The provided document describes the FDA 510(k) clearance for the Integra External Fixation System. This is a mechanical device, and the study described focuses on demonstrating its substantial equivalence to a predicate device through mechanical testing. It is not an AI/software device, and therefore, many of the requested metrics related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable or not provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described relate to the mechanical stiffness of the Integra External Fixation System compared to a predicate device.

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but it refers to "the construct" of both the predicate and the Integra system. This typically implies a statistically sufficient number of physical devices or components to perform mechanical testing.
• Data Provenance: The study was a prospective mechanical testing conducted by the manufacturer
  (Ascension Orthopedics/Integra LifeSciences). The country of origin for the data is not specified but would likely be the location where the manufacturer's testing facilities are located (e.g., USA).

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

• Not Applicable. For mechanical device testing, "ground truth" is established by standard engineering principles and validated testing methodologies, not by clinical experts. The testing would be performed by engineers or technicians skilled in biomechanical testing.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation or consensus, typically for diagnostic or prognostic devices. This was a mechanical engineering study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This was a mechanical engineering comparison of two external fixation systems, not a clinical study involving human readers or AI assistance in interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Not Applicable. This is a mechanical device, not an algorithm. There is no "standalone" algorithmic performance to report.

7. Type of Ground Truth Used

• The "ground truth" for this engineering study was the mechanical stiffness measured under dynamic and static loading conditions, as per established biomechanical testing standards. This would be quantified by physical measurements obtained from calibrated testing equipment.

8. Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set for this type of device, this question is not relevant.

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