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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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