Search Results

The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and/or sacral spine: 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., scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Mini-OSTEO Pedicle Fixation System consists of the following non-sterile, single-use components: monoaxial screws, polyaxial screws, rods, pedicle bars, laminar and transverse hooks, connectors, and a pedicle locking component for connectors. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.

The provided text details a 510(k) premarket notification for the "Mini-OSTEO Pedicle Fixation System." This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software or AI-driven devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML-driven medical device.

Specifically:

• No Acceptance Criteria Table: The document doesn't define quantitative or qualitative acceptance criteria for an AI/ML system's performance.
• No AI/ML Device Performance Study: The device described is a physical implant (pedicle fixation system), not a software or AI/ML-based diagnostic or therapeutic device. The "Non-Clinical Test Summary" and "Clinical Test Summary" sections confirm this:
  • Non-Clinical Tests: These are mechanical and material strength tests (e.g., ASTM F1717, F543, F1798), typical for orthopedic implants, to ensure mechanical safety and performance are equivalent to predicates.
  • Clinical Studies: The document explicitly states, "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to existing predicate devices.

Therefore, I cannot provide the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) because the provided text pertains to a physical medical device submission (pedicle fixation system) and not an AI/ML-driven device that would involve such performance evaluations.

Ask a specific question about this device