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TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.

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

The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.

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

An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.

6. Standalone (Algorithm Only) Performance Study

A standalone study was not performed, as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.

8. Sample Size for the Training Set

This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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The Bfix® Orthopedic External Fixator Systems is intended to be used on adults patients for bone stabilization in the lower limbs.

The indication for use includes:

• open or closed fractures in long bones;
• bone defects or reconstructive procedure
• limb lengthening

The Bfix® Orthopedic External Fixator Systems is an external fixation system that consists of various components used for the external stabilization of bone fractures. The external fixators components includes ring, connecting rods, thread rods, posts, couplings, telescopic struts, static struts, washer, clamps and pins that combined to construct different frame configuration which is appropriate for each specification application. The metallic bone pin is implanted into bone and then connected with the external components to form a rigid construct which holds the bone fragments rigidly in place.

The provided text is a 510(k) summary for the Bfix® Orthopedic External Fixator Systems, which is a medical device for bone stabilization. This document details the device's intended use, comparison to predicate devices, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the questions you've asked are typically relevant to the performance of an AI/ML-based medical device, particularly in terms of its diagnostic or evaluative capabilities. The Bfix® Orthopedic External Fixator Systems is a physical device, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are addressed through mechanical performance testing rather than diagnostic accuracy or human reader studies.

Here's how the provided information relates to your questions, with clarifications on why some questions are not applicable to this type of device:

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

The document states that the mechanical performance of the proposed device has been conducted according to ASTM F1541-17 and ASTM F543-17. These ASTM standards themselves define the acceptance criteria (e.g., minimum load to failure, maximum deformation under load, fatigue life cycles) and the test methods to measure performance (e.g., static bending strength, torsional stiffness, axial pull-out strength). The reported device performance would be the specific values obtained from these tests for the Bfix® system, which are then compared against the criteria within these ASTM standards and often against the predicate device's performance.

Specific results are not explicitly provided in this 510(k) summary (which often summarizes but doesn't include raw data), but the statement "Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device" implies that the Bfix® system met these acceptance criteria when compared to the predicate device and relevant standards.

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

For a physical device like an external fixator, "sample size" refers to the number of physical devices or components tested. The standards (ASTM F1541-17 and ASTM F543-17) would specify the required sample sizes for each type of mechanical test. The provenance is that the tests were performed on the Bfix® Orthopedic External Fixator Systems manufactured by Aike (Shanghai) Medical Instrument Co., Ltd. within China. These would be prospective tests performed specifically for this 510(k) submission.

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

This question is not applicable to this type of physical device. "Ground truth" established by experts (like radiologists for image analysis) is relevant for diagnostic or AI/ML-based devices. For mechanical devices, the "ground truth" is established by the physical testing methods described in the ASTM standards, and performance is measured by calibrated testing equipment, not human expert interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication (e.g., 2+1, 3+1 consensus) is used to resolve disagreements among human experts in diagnostic studies. For mechanical testing, the results are quantitative measurements, not subjective interpretations.

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. An MRMC study is specific to evaluating the impact of an AI/ML device on human reader performance, typically in diagnostic imaging. This device is a surgical implant, not an AI diagnostic tool.

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

This question is not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

This question is not applicable in the context of expert consensus or pathology for a physical device. The "ground truth" for a mechanical device's performance is derived from objective physical measurement against established engineering standards (ASTM F1541-17, ASTM F543-17) and comparison to the predicate device's known performance. For example, the "ground truth" for static bending strength is the force required to break the device as measured by a load cell, not a human interpretation.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.

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

This question is not applicable for the same reason as question 8.

Summary regarding the Bfix® Orthopedic External Fixator Systems:

The "acceptance criteria" for the Bfix® Orthopedic External Fixator Systems are the performance metrics defined by the relevant ASTM standards (ASTM F1541-17 and ASTM F543-17) for external fixators, as well as demonstrating substantial equivalence in performance to the predicate device (Orthofix Galaxy Fixation System).

The "study that proves the device meets the acceptance criteria" is the Non-Clinical Testing described in Section VII of the 510(k) summary, which included:

• Static bending test
• Static torsion test
• Single bending test
• Bending fatigue test
• Axial pull-out test
• Rotational torque test
• Self-tapping performance

These tests are designed to mechanically characterize the device's strength, stiffness, durability, and securement capabilities against established benchmarks and the predicate device. The conclusion (Section IX) states that "Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device," indicating that it successfully met the implied acceptance criteria based on these mechanical tests.

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The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.
The indications for use include:

• intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:
• polytrauma;
• carpal dislocations;
• unreduced fractures following conservative treatment;
• bone-loss or other reconstructive procedures:
• infection.

The Orthofix Galaxy Wrist is a complimentary system for the current Galaxy Fixation system, engineered specifically for the wrist. The primary objective of the Galaxy Wrist is to offer the possibility of distraction/compression and the mobilization of the joint. The device includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use. The system allows the surgeon to: - Position screws where the condition of the bone and soft tissues permits - Reduce the fracture in order to restore alignment

This is a 510(k) premarket notification for a medical device (Orthofix Galaxy Wrist external fixator), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert consensus, and training/test set details for an AI model is not present in the provided document.

The document describes the device's indications for use, technological characteristics, and performance data related to mechanical testing and MRI compatibility, demonstrating substantial equivalence to predicate devices. It explicitly states that "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

Therefore, I cannot provide the requested information.

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