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Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allo- grafts.

The MectaScrew PEEK® is an implantable device used for the reconstructive treatment of knee ligament ruptures. The primary purpose of the MectaScrew PEEK interference screw is to provide, via interference between the graft and the bone tunnel, a suitable and secure intra - tunnel graft fixation of the implanted ligament replacement giving stability, pain relief due to restoration of the normal anatomy, and improving articular functionality for patients treated. The MectaScrew PEEK® portfolio is composed of 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

The provided text is a 510(k) summary for the Medacta MectaScrew PEEK Interference Screw. This document is a premarket notification for a medical device seeking substantial equivalence to existing predicate devices, not a study describing the performance of an AI/ML medical device.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and performance studies for an AI/ML device. The criteria listed in the prompt are specific to the evaluation of AI/ML diagnostic or prognostic tools (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies), which are not relevant to a bone fixation screw.

The document discusses:

• Device description: A PEEK interference screw for ACL reconstruction.
• Predicate devices: Smith&Nephew BIOSURE PK® Interference screw (K083635) and Conmed MATRYX® Interference Screw (K063588).
• Technological characteristics: Comparison with predicate devices, noting material (PEEK), external shape, sterilization, and usage are similar, with differences in driver connection.
• Performance data (Non-Clinical Studies):
  • Design Validation (Cadaver Workshop)
  • MR compatibility
  • Pull Out Strength
  • Torque Resistance
  • Pyrogenicity (Bacterial endotoxin and Pyrogen tests)
• Clinical Studies: "No clinical studies were conducted."

In summary, this document describes a traditional medical device (an implantable screw) and its premarket clearance process based on substantial equivalence, primarily through non-clinical performance data and comparison to predicates, not an AI/ML device evaluation.

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The KSEA MegaFix®-C Elioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is a one-time use biodegradable implant, provided to the end user in a sterile condition, and intended for interference fixation of grafts in human cruciate ligament reconstruction. The device is a bioabsorbable composite interference screw which utilizes lactide polymer composite technology to perform the intended use.

The provided text describes the KSEA MegaFix®-C Bioabsorbable Composite Interference Screw, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria. It mentions the device description, indications for use, and technological characteristics, and lists predicate devices, but no performance study details are included.

Therefore, I cannot populate the requested table or answer the specific questions related to a study's methodology, sample sizes, ground truth, or expert involvement.

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