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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 carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.

The provided text is a 510(k) Summary for the EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and comparison to predicate devices, focusing on demonstrating substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for a diagnostic AI/ML device.

The 510(k) process for this type of medical device (external fixation system) primarily relies on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, fundamental scientific technology, and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The "study" here is essentially the comparison and justification of equivalence to predicate devices, rather than a clinical performance study with defined metrics.

Therefore, many of the requested sections about acceptance criteria, performance metrics, ground truth, sample sizes for test/training sets, experts, and adjudication methods are not applicable to this type of submission.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance Study for EBI® XFIX® DFS® System

This 510(k) submission (K040935) seeks marketing clearance for a modified EBI® XFIX® DFS® System by demonstrating substantial equivalence to predicate devices. The "study" to meet this requirement is a comparison of the new device's characteristics to those of predicate devices, asserting that the modifications do not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device submission demonstrating substantial equivalence, rather than a diagnostic AI/ML device, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics in the traditional sense. The "acceptance criteria" here implicitly revolve around demonstrating that the modified device's materials, intended use, and function are comparable to the predicate devices.

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

Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. The "test" for substantial equivalence is a comparison of specifications and intended use against existing cleared devices.

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

Not applicable. Ground truth as typically understood for diagnostic performance studies is not relevant here. The ground truth for regulatory clearance in this context is the safety and effectiveness of the predicate devices.

4. Adjudication method for the test set

Not applicable. No test set for diagnostic performance.

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 device is an external fixation system, not a diagnostic imaging or AI algorithm that assists human readers.

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

Not applicable. This is a physical medical device (external fixation system), not an algorithm.

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use. The submission aims to establish that the modified device is equally safe and effective due to substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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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 carbon fiber material for the Central Body Component, Ankle Clamp, and T-Clamp.

This document is a 510(k) summary for the modified EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and a comparison to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical or performance study for a diagnostic or AI-driven device would.

This 510(k) is for a modification to an existing, already cleared device (K953406). The modification involves adding carbon fiber material for certain components. The FDA’s review process for such modifications often focuses on showing that the new material does not significantly alter the device's safety or effectiveness compared to the predicate device, rather than requiring a new, comprehensive performance study with acceptance criteria and a detailed study design.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or provided in this type of submission.

Here's a breakdown of the available information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not explicitly detailed in the way software or diagnostic device acceptance criteria would be presented. For this type of mechanical device modification, "acceptance" is primarily based on demonstrating substantial equivalence to a predicate device, meaning there are no significant differences in intended use, materials, and function that would raise new questions of safety or effectiveness.

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

• Sample Size: Not applicable. There is no "test set" in the context of a clinical performance study as described for AI or diagnostic devices. The evaluation is based on material properties, design comparison, and functional assessment relative to the predicate.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This is not an MRMC study. It's a submission for a modification to a mechanical medical device, not a diagnostic imaging or AI-assisted system.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This device does not involve an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the context of a "ground truth" for diagnostic accuracy. The "truth" in this submission relies on demonstrating that the modified device's materials and design result in equivalent performance and safety to the already-cleared predicate device. This would typically involve engineering analysis, material testing (not detailed in this summary), and a comparison against the predicate's established characteristics.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

• Ground Truth Establishment: Not applicable.

In summary:

This 510(k) submission (K031919) is for a modified external fixation device. The "study" proving the device meets acceptance criteria is primarily an engineering and regulatory comparison demonstrating substantial equivalence to a predicate device (K953406). The modification involves the addition of carbon fiber material for certain components. The acceptance criteria are implicitly met by showing that this material change does not alter the fundamental scientific technology, intended use, or safety/effectiveness of the device compared to the predicate. This is a common pathway for device modifications that do not introduce new risks or intended uses.

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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 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 modified self-drilling and blunt-tipped bone screws to the System. The components of the System may be manufactured from materials such as Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy.

This looks like a 510(k) summary for a medical device modification, not a study report that would include detailed acceptance criteria and performance data as requested. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, innovative device might.

Therefore, many of the requested items (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of document because the submission is for a modification of an already cleared device and relies on showing it's as safe and effective as the predicate.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) summary. This document asserts substantial equivalence, meaning the modified device performs comparably to the predicate device, rather than fulfilling specific, novel performance criteria demonstrated through new testing. The "acceptance criteria" here are essentially "is substantially equivalent to the predicate device."

2. Sample Size for the Test Set and Data Provenance

Not applicable. This is a 510(k) for a device modification (addition of modified self-drilling and blunt-tipped bone screws). No new clinical test set or data provenance is detailed, as the primary argument is substantial equivalence to a previously cleared device. New clinical data is typically not required for such modifications unless there are significant changes to the intended use or technology that raise new safety or effectiveness concerns.

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

Not applicable. No new test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

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

Not applicable. This document does not describe any MRMC study. These types of studies are more common for diagnostic imaging AI devices, which is not what this device is.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done

Not applicable. This is a physical external fixation system, not an algorithm, so "standalone performance" in the AI sense does not apply.

7. Type of Ground Truth Used

Not applicable. As no new clinical study data is presented, no ground truth types are mentioned. The ground for approval here is the previously cleared predicate device.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set.

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

Not applicable. This is a physical medical device, not an AI or software device that utilizes a training set and ground truth.

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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 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 the Hip Distracter to the System.

This submission is a Special 510(k) Device Modification for the EBI® XFIX® DFS® Fixation System (K022319), adding a Hip Distracter. The submission relies on substantial equivalence to the predicate device, the EBI® XFIX® DFS® System (K953406).

Acceptance Criteria and Device Performance:

The document does not explicitly define acceptance criteria as a new device or a new clinical claim is not being made. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Study Information:

The provided document is a 510(k) summary for a device modification, not a clinical study report. Therefore, it does not describe a new clinical study with the traditional elements of acceptance criteria, sample size, ground truth, or expert review for performance evaluation. Instead, the "study" is a comparison to a legally marketed predicate device.

1. Sample size used for the test set and the data provenance: Not applicable. This submission is based on a comparison of device characteristics to a predicate, not a test set of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in clinical trials or diagnostic accuracy studies is not relevant here as there is no new clinical data being presented for review. The "ground truth" is established by the prior clearance of the predicate device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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/software device and no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this 510(k) is the regulatory acceptance and safety/effectiveness profile of the predicate device (EBI® XFIX® DFS® System K953406). The modified device is deemed substantially equivalent based on its inherent characteristics matching those of the predicate, and therefore, it is considered safe and effective for its intended use, similar to its predicate.
7. The sample size for the training set: Not applicable. This is not a machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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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 EBI® XFIX® DFS® 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® 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. This submission is for the modifications to the Ankle Clamp of the EBI® XFIX® DFS® System. The components of the System may be manufactured from materials such as titanium, stainless steel, and aluminum.

The provided document is a 510(k) Summary for the EBI® XFIX® DFS® System. It describes the device, its intended use, and states that it is substantially equivalent to a previously cleared predicate device (K953406).

Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The 510(k) summary focuses on demonstrating substantial equivalence based on intended use, materials, and function, rather than providing detailed performance data from new studies. The submission is for modifications to an ankle clamp of an already cleared system, suggesting that extensive new performance studies might not have been deemed necessary for this type of submission.

Therefore, I cannot provide the requested information from the given text. The relevant sections for performance data are absent.

Ask a specific question about this device

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 an Angulating Screw Clamp to the System.

This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance. Based on the provided text, there is no acceptance criteria or detailed study proving device performance in the way you've described.

Here's why and what the document does include, addressing your points:

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

• Not Applicable. The document explicitly states that the submission is "only for the addition of an Angulating Screw Clamp to the System" and that "The intended use and fundamental scientific technology have not changed from the previously cleared submission." It relies on substantial equivalence to a predicate device (EBI® XFIX® DFS® System K953406) rather than new performance testing against specific acceptance criteria.
• The comparison focuses on:
  • Same materials (aluminum, stainless steel, titanium alloy).
  • Same indications for use (leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to external fixation).
  • Similar design principle for bone screw clamps.
  • Provided non-sterile.
• The conclusion 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."

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

• Not Available. No new clinical or performance test set data is presented for the modified device. The submission relies on the existing clearance of the predicate device.

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 new ground truth establishment is described as there's no new performance study data presented.

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

• Not Applicable. No new test set and adjudication method is described.

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 a hardware modification for an external fixation device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not Applicable. As above, this is not an algorithm or AI device.

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

• Not Applicable. No new ground truth is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable. There is no mention of a training set as this is not a learning algorithm or AI device.

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

• Not Applicable. As there is no training set, there is no corresponding ground truth establishment described.

In summary: This 510(k) submission seeks clearance for a modification to an existing device (the addition of an Angulating Screw Clamp). The primary "study" proving it meets "acceptance criteria" is the demonstration of substantial equivalence to a previously cleared predicate device. This is achieved by comparing the materials, intended use, function, and manufacturing process of the modified device to the predicate, and asserting that there are no significant differences. New extensive performance studies, as one might find for novel devices or AI systems, are not typically required or presented for such substantial equivalence claims.

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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 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 component to the System.

The provided text describes a 510(k) submission for a device modification of the EBI® XFIX® DFS® Fixation System. It explicitly states that "The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a component to the System." This type of submission, a Special 510(k), focuses on demonstrating that the modified device remains substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness.

Therefore, the submission does not contain a new study that establishes acceptance criteria and proves the device meets them from scratch. Instead, it relies on the predicate device's existing clearance and demonstrates that the modification does not alter the fundamental performance or safety profile.

Based on the provided text, I cannot fill out the requested table or answer most of the questions as a new study with explicit acceptance criteria and performance data is not presented or required for this type of 510(k) modification.

However, I can provide information based on what is stated:

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

Not applicable. This 510(k) is for a device modification and asserts substantial equivalence to a predicate device (EBI® XFIX® DFS® System K953406). No new acceptance criteria or performance data for the modified device are presented. The key "performance" reported is its substantial equivalence to the predicate.

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. No new test set or clinical study data is presented for this modification. The documentation focuses on engineering and material comparisons to establish substantial 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 new ground truth establishment process is described. The basis for safety and effectiveness relies on the predicate device's clearance.

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

Not applicable. No new test set requiring adjudication is described.

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 device is a mechanical external fixation system. It is not an AI-powered diagnostic or therapeutic device, and therefore MRMC studies are not relevant.

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

Not applicable. This device is a mechanical external fixation system, not an algorithm.

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

Not applicable. For this specific 510(k) modification, "ground truth" is primarily based on the demonstrated safety and effectiveness of the predicate device (EBI® XFIX® DFS® System K953406) through its prior clearance, and the engineering assessment that the modification does not introduce new safety or effectiveness concerns.

8. The sample size for the training set:

Not applicable. This device is a mechanical external fixation system and does not involve AI/machine learning requiring a training set.

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

Not applicable. This device is a mechanical external fixation system and does not involve AI/machine learning.

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