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The SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (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), and/or tumor. The SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use.

The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.

SP-Fix®: The SP-Fix® Spinous Process Fixation Plate consists of plates, rods and barrels that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients.

RELIEVE®: The RELIEVE® Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE® implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

The provided document is a 510(k) premarket notification from the FDA for two medical devices: the SP-Fix® Spinous Process Fixation Plate and the RELIEVE® Laminoplasty Fixation System. It confirms that the FDA has reviewed the submission and determined that the devices are substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain information related to the acceptance criteria and the study that proves a device meets given acceptance criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, expert involvement for ground truth, adjudication methods, or MRMC studies for a test set.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for and establishment of ground truth for a training set.

The document states under "Performance Data":

"Globus is not aware of any performance standards or special control as established to date for the above device or product code. Testing was conducted in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Static and Dynamic Compression and Static Cantilever Bending testing performed on the RELIEVE® plates demonstrates substantial equivalence to the predicate devices. No additional mechanical testing for SP-Fix® plates was performed."

This indicates that mechanical testing was performed to demonstrate substantial equivalence to predicate devices, rather than to meet specific performance acceptance criteria for a new, AI-based device. The context of your request (acceptance criteria, test/training sets, ground truth, experts, MRMC, etc.) strongly suggests an AI/ML medical device, which is not what this FDA submission describes.

Therefore, I cannot fulfill your request using the provided text because the document does not discuss the kind of performance studies (e.g., involving AI/ML, human readers, or specific diagnostic accuracy metrics) that your detailed questions pertain to.

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