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The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.

This document is a 510(k) premarket notification for a medical device called the "NeoSpan™ Compression Staple Implant w/instruments." It's a regulatory submission to the FDA, not a study report demonstrating the device meets clinical acceptance criteria.

Therefore, the information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria, such as specific performance metrics like sensitivity, specificity, or accuracy, is not present in this document.

This document focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating clinical efficacy or performance against specific acceptance criteria for an AI/device performance study.

Here's why the requested information cannot be extracted from the provided text:

• This is not an AI/Software as a Medical Device (SaMD) submission: The device is a physical implant (bone staple), not a software algorithm. Therefore, concepts like "ground truth," "expert consensus," "MRMC studies," "training set," or "test set" in the context of AI model performance are not applicable here.
• Performance Data Section VII: This section states, "Testing including pyrogenicity, corrosion, static bending, fatigue bending and pullout fixation was performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." These are engineering and biocompatibility tests for a physical implant, not clinical performance metrics or acceptance criteria for a diagnostic/AI device.
• Acceptance Criteria and Device Performance Table: Since this is a physical device establishing substantial equivalence, there are no "clinical acceptance criteria" in the sense of predictive performance (e.g., sensitivity, specificity) for an AI model. The criteria are related to mechanical properties and biocompatibility. The document only broadly states "results of the testing demonstrate that the device is substantially equivalent," without providing specific numerical performance data against pre-defined acceptance thresholds for these engineering tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These terms and concepts are relevant to the validation of AI/ML models or diagnostic devices. They are not applicable to the 510(k) submission for a physical bone staple, which relies on engineering testing and comparison to a predicate.

In summary, the provided document is a regulatory submission for a physical medical device (bone staple) seeking 510(k) clearance based on substantial equivalence. It does not contain the type of study data or acceptance criteria relevant to an AI/ML diagnostic or prognostic device as implied by your detailed questions.

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