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The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® system are unilateral 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.

The EBI® XFIX® Access™ Pelvic Fixator System has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic Fixator System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI® XFIX® Access™ Pelvic Fixator System is attached to the shanks of the bone screws. This submission is for the use of a Break-Away pelvic screw (clamp screw).

The provided text is a 510(k) Summary for the EBI® XFIX® Access™ Pelvic Fixator. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel diagnostic or AI-driven device.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes no clinical test set in the way typically seen for performance studies of AI or diagnostic devices. The testing mentioned appears to be engineering or functional testing of the device itself and its modifications, not a study involving patient data.

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

Not applicable. No ground truth based on expert review of a test set is mentioned.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is mentioned.

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

No MRMC study was conducted or reported. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this mechanical external fixator.

6. Standalone Performance Study (Algorithm Only):

No standalone performance study of an algorithm was conducted or reported. This device is a mechanical external fixation system.

7. Type of Ground Truth Used:

Not applicable. The "ground truth" for this device's acceptance seems to be adherence to applicable standards and successful functional testing of its mechanical properties, rather than diagnostic accuracy against a clinical reference standard.

8. Sample Size for the Training Set:

Not applicable. This document pertains to a mechanical medical device, not an AI or machine learning model that would require a training set.

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

Not applicable, as no training set is relevant to this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

This indicates that the "study" was likely engineering or functional testing to confirm that the changes (specifically the "Break-Away pelvic screw (clamp screw)") did not negatively impact the device's performance and that it continued to meet established requirements for external fixation devices. No clinical study with patient data or expert review is described as part of this 510(k) submission for substantial equivalence. The primary evidence for acceptance is the demonstration of substantial equivalence to a legally marketed predicate device through engineering and functional testing.

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The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices 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.

The EBI® XFIX® Access™ Pelvic Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic Fixator is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI® XFIX® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.

This 510(k) summary describes a device, the EBI® XFIX® Access™ Pelvic Fixator, which is a physical medical device and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes (carbon fiber bar replacing a titanium bar). Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth, which are typically relevant for AI/ML device evaluations, are not applicable to this submission.

The closest information provided related to device performance is a general statement about compliance with applicable standards and meeting all functional requirements for the modified device.

Here's a breakdown of why each requested point is not present in the provided document, given the nature of the device:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or quantitative performance metrics typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). The submission's focus is on material equivalence and functional equivalence for a physical fixator.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm for this physical device. The testing likely involved mechanical and material performance tests, not data analysis on patient cases.
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. There is no ground truth, expert consensus, or clinical data analysis in the manner expected for AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
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 is not an AI-assisted diagnostic or decision-support device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The information in this 510(k) pertains to a physical medical device (an external fixator) and not an AI/ML algorithm. As such, the specific criteria and study details requested (which are typical for AI/ML device evaluations) are not present in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that a material change (carbon fiber bar) maintains the device's intended use and functional requirements.

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