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The NEUROShield™ medical image processing software is intended for automatic labelling, visualization, and volumetric quantification of the Hippocampus brain structure from a set of MR images.

NEUROShield™ is a fully automated brain geometry-based quantifying analytics tool/cloud platform that uses Al/Deep Net to support physicians as a clinical decision support tool for neurologists and neuroradiologists. NEUROShield™ takes 3D MR images as input and calculates brain volumes that can assist physicians in devising optimal treatment plans. The Al tool branded as NEUROShield™ provides volumetric measurements of the Hippocampus brain structure. It replaces time-consuming manual processes with leading-edge automated technology that accelerates the analysis for clinical and research purposes. Brain Volume Quantification is a wellestablished methodology for differential and enhanced interpretation of medical images. We are using a locked algorithm, and any proposed modifications will be submitted to the FDA for review.

Here's a summary of the acceptance criteria and the study that proves NEUROShield meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 280 subjects
• Data Provenance:
  • Country of Origin: USA (collected from the publicly available ADNI - Alzheimer's Disease Neuroimaging Initiative - dataset, with approximately equal geographical distribution across East, Central, and West US regions).
  • Retrospective or Prospective: Retrospective

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: 3
• Qualifications: US Board Certified Radiologists

4. Adjudication Method for the Test Set

• Adjudication Method: The ground truth was established by combining the manual segmentations of the 3 radiologists into one tracing per case using the STAPLE (Simultaneous Truth and Performance Level Estimation) algorithm. This STAPLE-derived ground truth was then compared with individual radiologist segmentations to ensure validity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study that assesses the effect size of human readers improving with AI vs. without AI assistance was not reported in this summary. The study focuses on evaluating the standalone performance of the NEUROShield™ algorithm against an expert-derived ground truth.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance study was done. The NEUROShield™ algorithm's automated segmentations and volume calculations were directly compared against the ground truth established by expert radiologists.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus, specifically "STAPLE-derived ground truth building on the three US Board Certified Radiologists' provided segmentations."

8. The Sample Size for the Training Set

• Sample Size: 186 cases

9. How the Ground Truth for the Training Set Was Established

• The ground truth for the training set was established by manual segmentation of the Hippocampus structure by subject matter experts. This manually segmented data was then used as input to train the deep net Segmentation Model.

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Under supervision of a healthcare professional
· NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.

NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. When hydrated, NeuroShield™ is easy to handle, soft, pliable, nonfriable, porous and transparent.
NeuroShield™ is provided as a sterile, non-pyrogenic rectangular sheet in the size of 40 x 30 x 0.03 mm and is intended for single use.
NeuroShield™ is perforated to support the transport of physiological liquid through the wall of the device thereby easing the attachment to nerve tissue. With a diameter of 0.2 mm the holes make up 0.8% of the surface area of NeuroShield™.
NeuroShield™ can easily be placed over the injured nerve, and can be sutured if necessary. Furthermore, the device can be trimmed or shaped to the appropriate size to fit the nerve tissue to be treated.

The Monarch Bioimplants GmbH NeuroShield device is a chitosan membrane intended for the repair of peripheral nerve injuries where no gap exists or where a gap can be closed by flexing the extremity.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in a pass/fail format. Instead, it presents summaries of various tests and their results, consistently concluding that NeuroShield™ is "as safe as" and "performs as well as" or shows "substantial equivalence" to its legally marketed predicate devices (Cova™ORTHO-NERVE, Reaxon® Plus, and Nerbridge™).

However, based on the described results, we can infer the implied acceptance criteria for each test:

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