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The BIOFOAM® Bone Wedge is intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:

• · Cotton and Evans Wedges:
  • · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
  • · Opening wedge of Medial Cuneiform or Cotton osteotomies
  • · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
  • · Metatarsal/Cuneiform arthrodesis
• · Midfoot Wedges:
  • · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
  • · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
• Subtalar Implant:
  • Hindfoot Arthrodesis

This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

The BIOFOAM® Bone Wedge is a titanium metal foam implant used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

This document is a 510(k) summary for the BIOFOAM® Bone Wedge, a medical device for internal bone fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design parameters (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies), for a software or AI device is not applicable or present in this document.

However, I can extract what is available regarding the device and its testing:

Device: BIOFOAM® Bone Wedge
Type: Titanium metal foam implant used for angular correction of small bones of the foot.

1. Table of acceptance criteria and the reported device performance:

Explanation: The document states that "Fatigue testing was provided to support the substantial equivalence of the subject device." This suggests that the acceptance criterion was related to the device's ability to withstand fatigue, likely to a standard or a level comparable to the predicate device. The "reported performance" is that the testing was conducted and presumably met the (unspecified in this summary) criteria.

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

• Sample size: Not specified.
• Data provenance: Not applicable in the context of a clinical study. The test involved a non-clinical (mechanical) evaluation of the device.

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

• Not applicable. This was a non-clinical, mechanical fatigue test, not a study requiring expert clinical assessment of ground truth.

4. Adjudication method for the test set:

• Not applicable. This was a non-clinical, mechanical fatigue test.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 performed.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• Not applicable. The "ground truth" for a mechanical fatigue test would typically be the physical observation of material failure or the number of cycles completed under defined load conditions.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device and no training set was involved.

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

• Not applicable. This is not an AI/software device.

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The BIOFOAM® Bone Wedge is intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Cotton and Evans Wedges:

• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform or Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• Metatarsal/Cuneiform arthrodesis

· Midfoot Wedges

• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)

This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

This document is a 510(k) premarket notification for the BIOFOAM® Bone Wedge, a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance from a study in the typical sense of algorithm or diagnostic device evaluation.

Therefore, the requested information cannot be fully provided as it pertains to a different type of regulatory submission (a medical device 510(k) which primarily relies on demonstrating substantial equivalence, especially based on non-clinical evidence in this case, rather than demonstrating performance against specific clinical acceptance criteria).

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

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

This information is not present in the document. 510(k) submissions typically do not include 'acceptance criteria' in the same way an AI/diagnostic device validation study would. Instead, they demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "performance" reported is primarily in the context of non-clinical testing to show this equivalence.

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

This information is not applicable/not present in the context of the provided document. This 510(k) relies on non-clinical testing (morphological characterization, abrasion, friction, compression, fatigue, biocompatibility) rather than a clinical test set with patient data.

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)

This information is not applicable/not present. Ground truth, as typically understood in diagnostic or AI device studies, is not established for this type of non-clinical testing.

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

This information is not applicable/not present.

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 information is not applicable/not present. This is a physical bone wedge, not an AI or diagnostic tool that would involve human readers.

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

This information is not applicable/not present. This is a physical bone wedge.

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

This information is not applicable/not present. The "truth" in this context is established by engineering and material science standards for the non-clinical tests.

8. The sample size for the training set

This information is not applicable/not present. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not present.

Summary of what is available in the document regarding "study" and "performance":

The document states:

• Study Type: Non-clinical (bench testing) and biocompatibility testing.
• Tests Conducted: Morphological characterization, abrasion, friction, compression, fatigue, chemical composition, and animal testing.
• Purpose of Tests: To support the equivalence of the subject device (BIOFOAM® Bone Wedge) to its predicate devices and demonstrate that "no new worst-case devices are introduced in this system."
• Conclusion from Tests: "The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification."
• Clinical Evidence: Explicitly stated as "N/A" (Not Applicable), indicating no clinical studies were performed or submitted.

This 510(k) submission successfully demonstrated substantial equivalence based on non-clinical evidence only, which is common for devices of this type.

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The BIOFOAM® Bone Wedge is internal bone fixation for bone fractures, fusions, or osectornies in the ankle and foot, such as:

• Cotton and Evans Wedges:
• Opening wedge osteotomics of the bones of the foot including osteotomics for Hallux Valgus
• Opening wedge of Medial Cunciform or Cotton osteotomies
• Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcancal Z Osteotomy)
• Metatarsal/Cunciform arthrodesis
• Midfoot Wedges
• Opening wedge osteotomics of the bones of the foot including osteotomies for Hallux Valgus
• Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT or Lapidus)
  This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.

The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

The provided text describes the 510(k) summary for the WMT BIOFOAM® Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of AI/ML device testing.

Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission relies on non-clinical engineering testing (compression and fatigue testing) and comparison to a predicate device, not a test set of data in the AI/ML sense. No specific "sample size" of clinical cases or data is mentioned. Data provenance is therefore not relevant.

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

• Not applicable. There was no expert-established ground truth for a test set in the context of an AI/ML device. The evaluation was based on engineering principles and comparison to a predicate.

4. Adjudication Method

• Not applicable. No adjudication method was mentioned as it was not a clinical study involving human interpretation.

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

• No. An MRMC study was not done. This is a medical device (bone wedge), not an AI/ML diagnostic or assistive tool for 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, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on:
  • Engineering specifications and test standards: for compression and fatigue performance.
  • Material properties: showing identity to the predicate device.
  • Design characteristics comparison: ensuring no new safety or effectiveness concerns.

8. The Sample Size for the Training Set

• Not applicable. There was no training set, as this is not an AI/ML device.

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

• Not applicable. There was no training set.

Ask a specific question about this device

The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
· Metatarsal/cuneiform arthrodesis
This device is intended for use with ancillary fixation.

The BIOFOAM® Bone Wedge is not intended for use in the spine.

The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

This document is a 510(k) summary for the BIOFOAM® Bone Wedge, which is a medical device for internal bone fixation. It is a premarket notification to demonstrate substantial equivalence to a predicate device, not a study proving device performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document primarily focuses on:

• Intended Use: What the device is meant to treat (bone fractures, fusions, or osteotomies in the ankle and foot).
• Device Description: What the device is (a titanium metal foam wedge).
• Substantial Equivalence: The core argument of a 510(k) submission, stating that the device is as safe and effective as a legally marketed predicate device, without detailing specific performance data or clinical studies in this summary.

Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the type of performance study data or acceptance criteria typically associated with a clinical trial or performance validation study.

Ask a specific question about this device

The BIOFOAM™ Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:

• · Opening wedge osteotomies of Hallux Valgus
• · Evans lengthening osteotomies
• · Metatarsal/cuneiform arthrodesis.
  The BIOFOAM™ Bone Wedge is not intended for use in the spine.

The BIOFOAM™ Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered in one distinct design with varying widths and thicknesses to accommodate a variety of small bone applications.

The provided text describes a 510(k) submission for the BIOFOAM™ Bone Wedge, and it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device, rather than detailed performance study results against specific acceptance criteria.

Here's why the prompt's requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance: The document states, "The safety and effectiveness of the BIOFOAM™ Bone Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not provide a table of pre-defined acceptance criteria or specific performance metrics.
• Sample Size (Test Set) & Data Provenance: This information is typically found in a detailed clinical or non-clinical study report, which is not part of this summary. The 510(k) relies on "materials information, and analysis data," implying bench testing, but no specifics are given.
• Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving expert review (e.g., image-based diagnostic devices). The BIOFOAM™ Bone Wedge is a physical implant, and its evaluation would not typically involve expert ground truth establishment in this manner.
• MRMC Comparative Effectiveness Study: This type of study is for diagnostic devices where human readers interpret results, often with and without AI assistance. This is not applicable to a bone wedge implant.
• Standalone Performance: While the "analysis data" mentioned likely includes standalone performance (e.g., mechanical testing), the specifics of how it was measured and against what thresholds are not provided in this summary.
• Type of Ground Truth: For an implantable device, ground truth would usually refer to successful implantation, biocompatibility, mechanical integrity, and clinical outcomes. The document does not detail how this was established beyond "substantial equivalence."
• Sample Size (Training Set) & Ground Truth (Training Set): These are relevant for AI/ML device development. This device is a physical implant, not an AI/ML algorithm, so these concepts do not apply in this context.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device, which is the primary mechanism for 510(k) clearance. It does not include the detailed study design, acceptance criteria, and performance results that would be present in a comprehensive study report for a novel or more complex device.

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