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The OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.

The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D, Llactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only. They are available in several sizes: 9-25 mm bridge lengths, and 10-22 mm leg lengths. The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is a 510(k) summary for a medical device (OSSIOfiber® Compression Staple) and does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. It is a submission for a physical orthopedic implant seeking to expand its indications for use to include pediatric patients, based on substantial equivalence to previously cleared devices.

Therefore, I cannot extract the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to this type of device submission.

The document discusses:

• Device: OSSIOfiber® Compression Staple (an orthopedic implant)
• Purpose of Submission: To add pediatric patient populations (children 2-12 years and adolescents 12-21 years) to the indications for use.
• Basis for Clearance: Substantial equivalence to previously cleared predicate devices (K212594, K233302) and an additional predicate (K210582), as well as reference devices (K231272).
• Non-Clinical Data: Biocompatibility was established in prior clearances and referenced from other devices. No additional mechanical performance testing was deemed necessary because the expanded indication did not present a "new worst case" compared to already cleared predicates.

In summary, the information requested is not present in the provided text because the device and its submission type do not involve an AI/ML component or diagnostic testing that would require such performance evaluation metrics.

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OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.

The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.

The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy. fusion, or fracture. Substantial decradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only, and nonpyrogenic. The additional devices included in this submission are: 9 x 10mm, and 11 x 10 mm.

The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided document is a 510(k) Premarket Notification summary for the OSSIOfiber® Compression Staple. It describes the device, its intended use, and the non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML-driven medical device, digital health software, or any study involving human readers or ground truth established by experts.

The primary focus of this submission is on the physical and mechanical properties of a medical implant (a compression staple) and its biocompatibility. The acceptance criteria discussed are related to the mechanical performance of the staple and its degradation profile.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for a test set or data provenance for an AI/ML device.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set or how ground truth was established for a training set (as this is not an AI/ML device).

The document specifically mentions:

• Non-Clinical Data: "Static bending, bending fatique and pull-out testing were performed to verify the strength and fixation properties of the OSSIOfiber® Compression Staple, and to compare them to those of the primary predicate device, the OS2®-VP Varisation Staple (K153770). Testing on the subject device were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized."
• Biocompatibility: "Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate and reference devices (K212594, K203465) as well as a rationale."

These are standard engineering and biocompatibility tests for physical medical devices, not performance metrics for AI/ML algorithms.

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