Search Results

Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets.

The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons.

When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.

The provided text is a 510(k) summary for the Mochida Nerve Cuff, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for an AI/ML-based medical device. Therefore, it does not contain the specific information required to answer the questions about AI/ML device acceptance criteria and study designs (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details).

This document outlines:

• Device Description: Mochida Nerve Cuff is made from polyglycolic acid (PGA) sheet embedded in covalently cross-linked alginate gel, designed to repair peripheral nerve function by providing a scaffold for axon growth.
• Indications for Use: Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or management of peripheral nerve injuries with no substantial loss of nerve tissue.
• Predicate Devices: Collagen Matrix, Inc.'s Collagen Nerve Wrap (K060952) and Collagen Matrix, Inc.'s Collagen Nerve Cuff (K012814).
• Technological Characteristics Comparison: The document emphasizes the similarities in material biodegradability, form (sheet/wrap), fundamental science (scaffold for nerve cell growth), and single-use sterile presentation.
• Performance Data (Non-AI/ML):
  • Stability testing: Real-time and accelerated aging for product and packaging.
  • Transportation testing: According to ASTM D4169-22.
  • Pyrogenicity testing: Demonstrates non-pyrogenic status.
  • Biocompatibility testing: Conducted per ISO 10993-1, including chemical characterization, cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute toxicity, pyrogenicity, and genotoxicity. Note: Hemolysis testing conclusion states "No conclusion was drawn for hemolytic potential."
  • Bench testing: Comparative tests for tensile strength, suture retention strength, pH, stiffness, degradation, swelling rate, and porosity.
  • Animal study: Two rat sciatic nerve models (transection and no transection) compared the Mochida Nerve Cuff to predicate devices and included a sham arm. Results demonstrated similar safety and performance to predicate devices.

Conclusion: The document concludes that the Mochida Nerve Cuff is substantially equivalent to the predicate devices based on intended use, indications, technological characteristics, and performance testing.

Therefore, I cannot provide the requested information about acceptance criteria and study designs for an AI/ML medical device, as the provided text describes a non-AI/ML nerve cuff device.

Ask a specific question about this device