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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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