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Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as:

• Open wedge osteotomies of Hallux Valgus .
• Evans lengthening osteotomies .
• Metatarsal/cuneiform arthrodesis .

Biomet Reconstructive Wedges are intended for use with ancillary fixation.

Biomet Reconstructive Wedges are not intended for use in the spine.

Biomet Reconstructive Wedges are metallic blocks designed for insertion into voids for alignment of bones in the foot or ankle. There are two styles of wedges which are oval and rectangular in shape. Wedges are available in a variety of widths, lengths and thicknesses. Rectangular cut-out windows allow the surgeon to pack allograft within the device. The wedges are completely porous, to allow for tissue ingrowth. There is a "skin" of solid titanium on the outer edge of the component to facilitate the insertion instrument and allow for identifying part marking to be added to the devices.

The Biomet Reconstructive Wedges are metallic blocks designed for insertion into voids for alignment of bones in the foot or ankle. The device comes in two styles (oval and rectangular) and various sizes. It features rectangular cut-out windows for allograft packing and is completely porous for tissue ingrowth, with a solid titanium "skin" on the outer edge.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Functional performance within intended use.	"The results of testing indicated the material performed within the intended use..." Specific quantitative criteria are not listed in this document.
   No new safety and efficacy issues raised.	"...did not raise any new safety and efficacy issues..."
   Substantial equivalence to predicate devices.	"...and were found to be substantially equivalent to the predicate devices." (Specifically to Wright Medical Technology Inc.'s BIOFOAM® Bone Wedges cleared through K070592, K073535, and K093950).
   Acceptable Chemical Composition	Non-Clinical Test Performed. Results not explicitly detailed but implied as acceptable for substantial equivalence.
   Acceptable Static Shear Strength	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Static Compression Testing	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Dynamic Compression Testing	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Expulsion Testing	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Compressive Strength	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Porosity/Pore Size	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Taber Abrasion	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Interconnectivity	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Roughness	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Tensile Adhesion	Non-Clinical Test Performed. Results not explicitly detailed.
   MR Compatibility	Non-Clinical Test Performed. Results not explicitly detailed.
   Acceptable Microstructure	Non-Clinical Test Performed. Results not explicitly detailed.
   No adverse animal data (if applicable)	Animal Data was collected as a Non-Clinical Test, implying results were acceptable.
   No need for clinical data for substantial equivalence	"No clinical data was necessary for a determination of substantial equivalence." and "No clinical data submitted." This indicates that non-clinical data was sufficient to meet the regulatory standard for this device type and its predicate.

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

   • The document primarily references non-clinical tests. These tests likely involved a sample size of material specimens or device prototypes as per relevant ASTM or ISO standards for testing medical implants. However, the exact sample sizes for each specific test are not mentioned in this summary.
   • Data provenance: Not specified in the provided summary (e.g., country of origin). The studies are non-clinical, meaning they were likely laboratory or bench-top tests. The document states "No clinical data submitted," so there is no patient data provenance to describe.

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

   • Since this submission relies on non-clinical performance data and does not involve AI or human interpretation of medical images/data, there is no mention of experts establishing a "ground truth" in the traditional sense of clinical or diagnostic studies. The "ground truth" for the non-clinical tests would be the accepted industry standards and methodologies for evaluating material and mechanical properties of medical devices.

4. Adjudication method for the test set:

   • Not applicable. The listed performance data stems from non-clinical (benchtop) tests, not subjective interpretations requiring adjudication.

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 passive implant for bone fixation, not an AI-assisted diagnostic or interpretative tool. 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 a physical medical device, not an algorithm or software. Its performance is inherent to its material and design, evaluated through physical testing.

7. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" would be established by engineering standards and specifications for material properties and mechanical performance relevant to bone fixation devices. This includes, but is not limited to, industry standards, relevant ISO/ASTM guidelines, and internal company specifications derived from the intended use and predicate devices. There is no biological/clinical ground truth (e.g., pathology, outcomes data) as no clinical studies were performed.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

   • Not applicable, as there is no training set for this type of device submission.

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