Search Results

The Pedimax II - Pedicle Screw Spinal System is indicated for posterior, non-cervical fixation in skeletally mature patients. It is intended to be used as an adjunct to fusion using autograft. The device is indicated for the treatment of the following acute and chronic instabilities or deformittes: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Pedimax II - Pedicular Screw Spinal System." This document primarily deals with the regulatory clearance of a physical medical device (spinal pedicle screws) rather than an AI/software-as-a-medical-device (SaMD) or AI-assisted diagnostic device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-based device (e.g., ground truth, sample size for test/training sets, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.

The document discusses:

• Device Name: Pedimax II - Pedicular Screw Spinal System
• Regulation Number and Name: 21 CFR 888.3070, Thoracolumbosacral pedicle screw system
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion using autograft for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion.
• Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The "study" referenced in the prompt (proving the device meets acceptance criteria) for a physical medical device like this would typically involve:

• Mechanical Testing: Fatigue testing, static compression/tension, torsion, pull-out strength, etc., to ensure the device meets specified mechanical performance attributes.
• Biocompatibility Testing: According to ISO 10993 standards, to ensure the materials are safe for implantation.
• Sterilization Validation: To ensure the device can be consistently sterilized.

However, the 510(k) clearance letter itself does not contain the details of these studies or their specific acceptance criteria and results. It only states that the FDA has reviewed the submission and found the device to be substantially equivalent, implying that the manufacturer provided sufficient data (including performance testing) to support the claim.

Ask a specific question about this device