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The EBI® XFIX® DFS® Metaphyseal Correction System is a 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® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction 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® DFS® Metaphyseal Correction System is attached to the shanks of the bone screws. This submission is for the addition of a locking set screw to the system.

This 510(k) premarket notification for the EBI XFIX® DFS® Metaphyseal Correction System does not contain the acceptance criteria or a study proving that the device meets acceptance criteria in the typical sense of a clinical or performance study for a diagnostic AI device.

Instead, this document is a premarket notification (510(k)) for a medical device that has not significantly changed from its predicate device. For such devices, the primary "acceptance criterion" is Substantial Equivalence to a legally marketed predicate device. The "study" that proves this is essentially the submission itself, which details the device's characteristics and compares them to the predicate.

Here's why many of your requested points are not applicable to this type of submission:

• This is not an AI device. The submission describes an external fixation device, which is a physical implant, not a software algorithm. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," and "standalone algorithm performance" are not relevant.
• The "performance" is demonstrated through equivalence. For 510(k)s, especially for devices undergoing minor modifications or demonstrating direct substantial equivalence, extensive de novo performance studies as you might see for novel AI/diagnostic devices are typically not required. The "acceptance criteria" here are met by showing that the modified device is as safe and effective as the predicate.

Given this, I will answer the applicable questions based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Device Performance

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission is for a physical external fixation device and relies on demonstrating substantial equivalence to a predicate device, not on clinical performance data from a test set in the context of an AI/diagnostic study. There is no "test set" in the sense of patient data being analyzed by an algorithm.

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. As this is not an AI/diagnostic device, there is no "ground truth" established by experts for a test set. Substantial equivalence is determined by regulatory review and comparison to predicate devices, not by expert consensus on clinical data for the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no "test set" or adjudication method relevant to this 510(k) submission.

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 device or a diagnostic device where human reader performance with or without AI assistance would be studied.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this type of 510(k) submission, the "truth" is established by the documented characteristics of the device and its predicate, along with regulatory guidelines, rather than by a specific clinical "ground truth" derived from patient data. The FDA's determination of substantial equivalence serves as the regulatory "truth" for market authorization.

8. The sample size for the training set

• Not applicable. This submission is not for an AI/machine learning device that requires a training set.

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

• Not applicable. As there is no training set, there is no associated ground truth to establish.

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The EBI® XFIX® DFS® System is 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 System consists of external fixation components and implantable bone screws. The EBI XFIX DFS 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 DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a XS Gradual Swivel Clamp to the System.

This FDA submission for the EBI® XFIX® DFS® System is a 510(k) for a modified device, meaning it is seeking clearance based on substantial equivalence to a legally marketed predicate device rather than presenting a new product. Therefore, a study demonstrating device performance against specific acceptance criteria is not included in this document.

510(k) submissions for substantial equivalence generally focus on demonstrating that the new device shares fundamental scientific technology, intended use, materials, and functional characteristics with a previously cleared predicate device, and that any differences do not raise new questions of safety or effectiveness. They do not typically require new clinical studies with defined acceptance criteria and statistical analysis in the same way a PMA (Pre-Market Approval) or de novo submission would.

Here's an analysis based on the provided text, highlighting why most of your requested information is not applicable or cannot be extracted:

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

• Not applicable / Not provided. This document does not establish specific performance acceptance criteria for the modified EBI® XFIX® DFS® System, nor does it report on a study designed to demonstrate performance against such criteria. The basis for clearance is substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No test set or clinical study data is presented in this 510(k) summary. The submission relies on a comparison of technological characteristics to a predicate device, not on new performance data from a "test set."

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 / Not provided. As no test set or clinical study is described, there's no mention of experts establishing ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or clinical study, thus no adjudication method is relevant here.

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 / Not provided. This device is an external fixation system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

• Not applicable / Not provided. This is a mechanical external fixation device, not an algorithm, so independent algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Implicit Ground Truth for 510(k): The "ground truth" for a 510(k) substantial equivalence determination is the regulatory classification and established safety and effectiveness of the predicate device (EBI® XFIX® DFS® System, K953406). The submission argues that the modified device does not introduce new questions of safety or effectiveness compared to this already cleared device.

8. The sample size for the training set

• Not applicable / Not provided. This is a mechanical device, not an AI/machine learning system, so the concept of a "training set" is not applicable.

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

• Not applicable / Not provided. As above, the concept of a training set is not applicable to this submission.

Summary of Device Comparison (from Section 7):

The submission highlights the following points to demonstrate substantial equivalence:

• Materials: Fabricated from the same materials as the predicate device components (aluminum, stainless steel, titanium alloy).
• Intended Use: Both the modified and predicate devices are indicated for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other amenable bone conditions.
• Function: Bone screw clamps of the modified system are designed for attachment to bone screws, similar to the predicate.
• Sterility: The additional component (XS Gradual Swivel Clamp), like existing components, is provided non-sterile.

The core argument is: "There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function." The addition is specifically for an "XS Gradual Swivel Clamp."

This type of 510(k) relies on a direct comparison and argument of equivalence rather than new performance studies.

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The EBI® XFIX® DFS® System is 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 System consists of external fixation components and implantable bone screws. The EBI XFIX DFS 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 DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a Gradual Swivel Clamp to the System.

This submission is for a modification to an existing external fixation system, not a device that relies on AI or complex algorithms for performance. Therefore, the provided text does not contain any information about acceptance criteria or a study proving a device meets those criteria in the context of AI/algorithm performance.

The document is a 510(k) summary for a medical device (EBI® XFIX® DFS® System) that discusses:

• Sponsor and Contact Information
• Proprietary and Common Names
• Classification
• Predicate Device: EBI® XFIX® DFS® System (K953406)
• Device Description: The system consists of external fixation components and implantable bone screws. The submission is only for the addition of a Gradual Swivel Clamp.
• Intended Use: Treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by external fixation.
• Materials: Aluminum, stainless steel, and titanium alloy.
• Comparison to Predicate: The modified device is stated to be "substantially equivalent" to the predicate device in terms of materials, intended use, and function, with no significant differences. The added component (Gradual Swivel Clamp) is also non-sterile, like other components.
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

To directly answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is for a mechanical device modification, not a performance-based algorithm or AI system. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence to a predicate device, which is stated as having been met.
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 mention of a test set, data, or a clinical study for performance evaluation in the context of an algorithm. The assessment is based on mechanical and material equivalence.
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. No experts were used for ground truth establishment for a test set as described in the context of AI/algorithm evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no test set or adjudication for an algorithm.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's equivalence is being assessed.
8. The sample size for the training set: Not applicable. There is no training set mentioned for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a minor modification to an existing mechanical external fixation system. It relies on a demonstration of "substantial equivalence" to a predicate device rather than performance criteria derived from a study involving algorithms, data, or expert evaluation as you've outlined in your questions.

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The EBI® XFIX® DFS® System is a 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 system consists of external fixation components and implantable bone screws. The EBI® XFIX® DFS® System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. This submission is for a labeling change to reflect that the EBI® XFIX® DFS® Standard Fixator may be reused twice when the Central Body Component is replaced between each reuse.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) Summary for an external fixation device (EBI® XFIX® DFS® System) seeking clearance for a labeling change to allow reuse of a component.

The document focuses on:

• Device Description: An external fixation system that includes components and implantable bone screws, used for bone conditions.
• Intended Use: Treatment of bone conditions such as leg lengthening, osteotomies, arthrodesis, and fracture fixation.
• Predicate Device Comparison: States that there are no significant differences between the device and other marketed external fixation systems in terms of intended use, materials, and function, concluding substantial equivalence to prior predicate devices (K953406).
• Labeling Change: The specific purpose of this 510(k) is a labeling change to reflect that the EBI® XFIX® DFS® Standard Fixator may be reused twice when the Central Body Component is replaced between each reuse.

Therefore, the requested information regarding acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not available in the provided text. The document is a regulatory submission for substantial equivalence based on existing predicate devices and a specific labeling change, not a performance study report with predefined acceptance criteria.

Ask a specific question about this device

The EBI® XFIX® DFS® System is a 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 system consists of fixation components and implantable bone screws. The bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI XFIX® DFS® System is attached to the shanks of the bone screws. This submission is for the availability of a Central Body Variable Clamp.

This submission is a 510(k) premarket notification for a medical device, the EBI® XFIX® DFS® System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness. Therefore, the information typically gathered from such studies (like detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in this document for the new device.

The document focuses on comparing the new device to a predicate device (EBI® XFIX® DFS® System, K953406) based on materials, intended use, and function.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" for the new device are typically met by demonstrating that it is substantially equivalent to a predicate device that has already met its own safety and effectiveness criteria. The document explicitly states:

• "There are no significant differences between the proposed EBI® XFIX® DFS® System and the currently marketed EBI® XFIX® DFS® System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."

Therefore, the performance of the new device is assumed to be equivalent to the predicate, and no new performance data or specific acceptance criteria are presented for it.

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

This information is not applicable and not provided. This 510(k) submission is not based on a clinical study of the new device that would involve a test set. It relies on a comparison to an existing predicate device.

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

This information is not applicable and not provided. As no new clinical study was conducted for this 510(k) anlaysis, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This 510(k) submission is for an external fixation system, not a device typically evaluated with MRMC studies (which are common for imaging and diagnostic AI).

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone study was not done. This device is a mechanical external fixation system and does not involve algorithms or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable and not provided for the new device. The "ground truth" for a 510(k) submission of this type is essentially the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

Summary of Device and 510(k) approach:

The EBI® XFIX® DFS® System is an external fixation device. This 510(k) submission (K013739) is for a modification to an existing, legally marketed device (K953406) by introducing a "Central Body Variable Clamp."

The basis for regulatory clearance (510(k)) is by demonstrating "substantial equivalence" to the predicate device, not by conducting new clinical trials for safety and effectiveness that would generate performance data against specific acceptance criteria. The submission explicitly states equivalence in "intended use, materials, and function."

Therefore, the document does not contain the detailed study information you've requested as would be found in a submission requiring de novo clearance or a premarket approval (PMA) based on extensive clinical data.

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