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The Intraosseous Fusion Device System is indicated for use in skeletally mature individuals for fracture repair and arthrodesis, osteotomy, joint fusion and fragment fixation appropriate with the size of the implant including:

Minimally invasive reconstruction of fractures and joints; Fractures of the foot and ankle; Osteochrondritis dissecans, Ostero-Chondral Fractures, Other small fragment, cancellous bone fractures, Small joint fusion. Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures, Fractures of the fibula, malleolus, and calcaneus.

The Intraosseous Fusion Device System is not intended for spinal use.

The Intraosseous Fusion Device (IFD) is a threaded titanium implant that is designed to provide stabilization of bones, bone segments or bone fragments to facilitate arthrodesis. The implant has an interrupted external thread to facilitate placement and fixation. The implant is hollow, which allows packing of bone graft material, and fenestrated, which allows bone growth and formation throughout the implant. The implants come in a variety of diameters (6, 9, 12mm) and lengths (10, 15 & 20mm) to address different anatomy locations. The implants are made from Ti6-6Al-4V alloy. The Intraosseous Fusion Device System includes implants, the instruments necessary to implant them, and the tray system for transport, storage and sterilization. The system is provided non-sterile and requires steam sterilization at point of use. Single-use metallic implants are time stable. Reusable instruments are inspected in reprocessing for conditions compromising function. All instruments (except for k-wires) are reusable and can be reprocessed.

The provided document is a 510(k) summary for the Auxano Medical LLC Intraosseous Fusion Device System. It is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. This type of submission does not involve clinical studies with human participants for acceptance criteria related to diagnostic performance or multi-reader multi-case studies typically seen with AI/ML devices.

The acceptance criteria and "device performance" in this context refer to engineering and biocompatibility testing against recognized standards to ensure the device is safe and effective for its intended mechanical function, rather than diagnostic accuracy.

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

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)

The document describes engineering bench testing, not clinical studies with human test subjects. Therefore, traditional "sample size" for a test set (e.g., number of patients or images) and "data provenance" (country, retrospective/prospective) as understood for diagnostic device performance are not applicable here. The "sample size" would refer to the number of devices or components tested in each mechanical or validation test, which is not specified in this summary but would be detailed in the full test reports.

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 section is not applicable. The device is a physical intraosseous fusion device, not a diagnostic imaging or AI system requiring expert interpretation as ground truth for a test set. Ground truth is established through adherence to recognized engineering standards and biocompatibility tests.

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

This is not applicable as there is no diagnostic test set requiring human 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

This is not applicable. This device is a medical implant, not an AI/ML diagnostic software, and therefore MRMC studies are not performed for its evaluation.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Adherence to recognized international and national standards: e.g., ASTM F543, ASTM F2077 for mechanical properties; ISO 17665-1, ISO 14937 for sterilization; AAMI TIR12, AAMI TIR30 for cleaning; ISTA 3A for shipping.
• Biocompatibility testing: GLP cytotoxicity testing.
• Material specifications: Ti-6Al-4V (ASTM F136 & F3001).

These standards and tests define what constitutes acceptable performance and safety for such a device.

8. The sample size for the training set

This is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

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

This is not applicable as there is no AI/ML component or "training set" in the context of this physical medical device.

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