Search Results

MSFX MIKRON SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the MSFX MIKRON SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in the treatment of the treatment of the following acute and chronic instabilities or deformities:

-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, kyphosis, and/or lordosis)
  -Tumor

-Pseudoarthrosis; and failed previous fusion

Msfx Mikron System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-EL) that conforms to ASTM F136. Various sizes of these components are available.

The provided text is a 510(k) clearance letter from the FDA for a spinal fixation system (MSFX MIKRON SPINAL FIXATION SYSTEM). It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on the regulatory aspects of a traditional medical device (spinal implants), including:

• Device Name: MSFX Mikron Spinal Fixation System
• Regulation Number/Name: 21 CFR 888.3070, Thoracolumbosacral Pedicle Screw System
• Regulatory Class: Class II
• Product Code: NKB, KWP
• Indications for Use: Provides support during fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: K171497 (Mikron Spinal Fixation system), K212220 (Artfx Spinal Fixation System), K091445 (CD HORIZON SPINAL SYSTEM), K071373 (XIA 3 Spinal System).
• Device Description: Multi-component, posterior spinal fixation system made of titanium alloy.
• Testing: Biomechanical tests performed according to ASTM F2193 and ASTM F1717, demonstrating substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, its performance, study details (sample size, data provenance, expert ground truth, adjudication), or MRMC/standalone studies, as this document is not about an AI/ML medical device.

To answer your request, I would need a document pertaining to an AI/ML medical device.

Ask a specific question about this device