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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal system is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal system is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami spinal system is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 -S1), and for whom the device system is intended to be removed after solid fusion is attained.

The Moss Miami 6.35mm Polyaxial screws described in this submission are modifications of the previously cleared Moss Miami Polyaxial Screws. The head portion of the screw has been increased to allow the placement of a 6.35mm (1/4 inch) rod. The modified screws are available in the same thread diameters and lengths as the existing screws, namely 6.0mm, 7.0mm, and 8.0mm diameters and 30mm to 55mm lengths.

The 6.35mm polyaxial screws are manufactured from either implant grade titanium alloy or stainless steel that conform to ASTM standards F-136 and F-138, respectively.

The provided text describes specific details about a medical device (Moss Miami 6.35mm Polyaxial Screw) that has received 510(k) clearance, but it does not contain information related to software or AI-based devices. Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance), and training set information is not available in the provided text.

The document focuses on the mechanical and material characteristics of a pedicle screw modification and its substantial equivalence to previously cleared devices. It states:

• Device Description: The Moss Miami 6.35mm Polyaxial screws are modifications of previously cleared Moss Miami Polyaxial Screws. The head portion has been increased to allow for a 6.35mm (1/4 inch) rod. They come in 6.0mm, 7.0mm, and 8.0mm diameters and 30mm to 55mm lengths, made from implant-grade titanium alloy or stainless steel conforming to ASTM standards F-136 and F-138 respectively.
• Testing: "Testing was presented to evaluate the performance characteristics of the modified polyaxial screws. Specific tests of the construct included static tests in compression bending and torsion, and fatigue testing in compression bending."
• Substantial Equivalence Basis: "The substantial equivalence of the modified Polyaxial screws is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Moss Miami Polyaxial Screw System."

Without information on the specific acceptance criteria for these mechanical tests (e.g., minimum loads, cycles to failure, maximum deformation), or the detailed results of these tests, it's impossible to fill out the requested table or answer most of the questions. The document only states that "testing was presented to evaluate the performance characteristics," implying the data was submitted to the FDA for review, but the actual data and acceptance criteria are not included in this summary.

Therefore, I cannot provide the requested table and detailed study information as it pertains to AI/software performance acceptance criteria.

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