(12 days)
The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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 or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor,
- pseudoarthrosis, and/or
- failed previous fusion.
The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis
- trauma (i.e., fracture or dislocation),
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudarthosis, and/or
- failed previous fusion.
The Malibu Spinal System includes titanium alloy polyaxial reduction screws with a cobalt alloy component. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of a screw body and housing assembly. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also include locking caps in two different sizes. These items are designed to be part of the stand alone Malibu Spinal System, but are compatible with and will work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will offer a wide variety of instruments that range from modular taps to angled in-situ benders. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, aluminum, and Radel. These items are supplied "NON-STERILE" and must be sterilized prior to use.
The provided document does not describe an AI/ML powered device. Instead, it concerns a medical device called the "Malibu Spinal System," which is a traditional orthopedic implant for spinal fusion.
Therefore, the requested information elements such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document. These items are specific to the evaluation of AI/ML diagnostic or assistive devices, not mechanical implants.
The document focuses on demonstrating substantial equivalence of the Malibu Spinal System to predicate devices already on the market, primarily through comparison of:
- Intended Use
- Indications for Use
- Design
- Materials
- Sterilization
- Mechanical Strength
The acceptance criteria for such a device are typically met by demonstrating that its materials, design, and mechanical performance are equivalent to, or better than, legally marketed predicate devices, and that it is safe and effective for its intended use. The "study" mentioned for mechanical strength would be mechanical testing (e.g., fatigue, static strength) to ensure the device can withstand physiological loads, not clinical studies in the AI/ML context. The document explicitly states "Mechanical Strength: See test results," indicating that such tests were performed.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.