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The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Orbitum Bone Staple Implants, X and VI, have either radial or hourglass shaped superior profiles in three distinct sizes to coincide with the surgical approach. The legs of the device are configured to create compression upon implantation.

Orbitum Bone Staple Implants , are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Orbitum Bone Staple Implant, X and VI." This document describes the device, its intended use, and how it demonstrates substantial equivalence to predicate devices, primarily through non-clinical testing. It does not describe or reference a study involving acceptance criteria related to device performance in a clinical or diagnostic setting, nor does it involve AI or human readers.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance (in a clinical/diagnostic context).
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The information provided in the document focuses on non-clinical engineering and mechanical testing to establish substantial equivalence for regulatory approval.

Here's what the document does state concerning testing:

Non-clinical Testing:

• Study described: Testing according to ASTM F564 was performed on the ORBITUM Bone Staple.
• Tests performed: These included static compression bending, dynamic compression bending, and axial pull-out testing.
• Purpose: To establish equivalency to the predicate device in mechanical function and properties.
• Conclusion drawn: The Orbitum Bone Staple Implants are equivalent in mechanical function and properties to the predicate device, establishing equivalency in safety and effectiveness.

This kind of testing is typically done in a lab setting to ensure the device meets engineering specifications and performs mechanically as intended, rather than assessing diagnostic accuracy or clinical outcomes with human subjects.

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