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DuraFuse Clips are indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura mater in neurosurgical and orthopedic spine procedures.

NeuraMedica's DuraFuse Clip is a small, bioabsorbable, non-penetrating clip for rapid closure of the dura mater during spine surgery. DuraFuse Clips are applied individually using the reusable stainless steel NeuraMedica Applier has a low profile that allows visibility for implantation of clips in open or tubular retractor procedures.

NeuraMedica DuraFuse Clips are provided sterile and labeled for single use. Dural Clips are sterilized via a validated e-beam dose.

NeuraMedica's DuraFuse Applier is autoclavable. It is provided non-sterile.

The provided text describes a 510(k) premarket notification for the DuraFuse Clip and Applier System. It details the device's indications for use, comparison to a predicate device, and various performance data. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML-based medical device performance study.

The document focuses on demonstrating substantial equivalence to a predicate device (Auto Suture Modified VCS Clip Applier K962043) through:

• Biocompatibility testing: Consistent with ISO 10993-1, with passing results for cytotoxicity, irritation, and sensitization, and no expected long-term tissue responses.
• Bench top testing: Using a synthetic dural model, demonstrating successful approximation of synthetic dural material in defects from 1 cm to 10 cm without fluid leakage or damage to dura. This also states equivalent performance to the predicate device at higher pressures.
• Human Factors testing: In a human cadaver model, where fourteen experienced surgeons found components easy to use, the applier usable with one hand and allowing visibility, packaging easy for clip removal, and successful clip application based on instructions.
• Animal study (swine model): Demonstrating favorable tissue responses and dural closure with no evidence of CSF leakage after 14 or 90 days. All evaluated parameters were comparable between test and control groups.

Therefore, I cannot populate all the requested fields as the provided text does not contain information on an AI/ML device performance study with specific acceptance criteria, test set details, ground truth establishment, or MRMC studies as typically described for such devices.

However, I can extract information relevant to the non-clinical performance and "acceptance" from the provided text, interpreting "acceptance criteria" as the successful demonstration of equivalence or performance in the described tests.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance (Non-AI/ML):

• Applier can be used with one hand
• Applier allows visibility of the surgical site in open and tubular retractor procedures
• Packaging allows the user to easily remove clips for implantation
• Clips can be applied successfully based on the information in the Instructions For Use" (Note: The "acceptance" here is the unanimous or high agreement on these ease-of-use criteria by the surgeons. The text states "found that" this was the case, implying success). |
  | Animal Study (Equivalence/Safety): Favorable tissue responses, dural closure, no CSF leakage, comparability to control group in a swine model. | Successful. "After 14 or 90 days in the porcine spinal laminectomy and durotomy model, the DuraFuse Clip was associated with favorable tissue responses and dural closure with no evidence of CSF leakage. All parameters evaluated were comparable between the test and control groups." (Note: The "acceptance" here is absence of negative findings like CSF leakage and comparability to the control, demonstrating similar safety and effectiveness in the animal model). |

Information Not Present in the Document (Related to AI/ML Device Performance Studies):

1. Sample size used for the test set and the data provenance: N/A, not an AI/ML study. For human factors, 14 surgeons were used on human cadaver models. For the animal study, 8 swine were used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A, not an AI/ML study. For human factors, 14 "experienced surgeons" evaluated the device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A, not an AI/ML study.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A, not an AI/ML study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A, not an AI/ML study.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, "Assessment of dural contiguity at treatment sites was performed, specifically including indication of any presence of meningocoele/pseudomeningocoele" and "comprehensive necropsy followed by histomorphological examination." This serves as the ground truth for dural integrity and tissue response. For human factors, the surgeons' direct feedback on usability served as the ground truth.
7. The sample size for the training set: N/A, not an AI/ML study.
8. How the ground truth for the training set was established: N/A, not an AI/ML study.

This document is a traditional 510(k) submission for a physical medical device, not an AI/ML-driven software device. Therefore, the questions tailored for AI/ML device performance studies cannot be fully answered from this text.

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