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The Oculus-SA Lumbar Cage System is intended for spinal fusion procedures at one level (L2 to S1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the non-cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with bone graft. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system that has been cleared by the FDA. The Oculus-SA Lumbar Cage System implants with a lordotic angle less than 20°, when used with the internal fixation screws, do not require use of supplemental fixation.

The Oculus-SA Lumbar Cage System is a stand-alone spinal intervertebral fusion device made from medical grade PEEK (polyetheretherketone) as per ASTM F2026 or Ti 6Al-4V ELI Alloy as per ASTM F136. It is provided in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The PEEK cages have one radiographic marker pin made from tantalum, per ASTM F560. The implants incorporate integrated anterior screw holes to allow for placement of titanium alloy (per ASTM F136) screws. The Oculus-SA Lumbar Cage System is offered in either a three screw or four screw configuration for anterior lumbar interbody fusion procedures. Titanium alloy locking mechanisms secure the screws in place. The Oculus-SA Lumbar Cage System implants and instruments are provided non-sterile and will require sterilization prior to each use.

The provided text describes a medical device called the "Oculus™-SA Lumbar Cage System" and its 510(k) summary for FDA clearance. This document outlines the device's indications for use and states that its mechanical performance is substantially equivalent to legally marketed predicate devices. However, the document does not describe acceptance criteria, a specific study proving the device meets those criteria, or any details about a study involving AI, human readers, or ground truth establishment.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document focuses solely on demonstrating substantial equivalence through non-clinical mechanical testing, not through clinical or AI-related performance studies.

The "Performance Data" section lists several types of mechanical tests performed, such as:

• Static axial compression per ASTM F2077-18
• Static compressive shear per ASTM F2077-18
• Dynamic axial compression per ASTM F2077-18
• Dynamic compressive shear per ASTM F2077-18
• Static subsidence per ASTM F2267-04 (2018)

It concludes that "The results of this non-clinical testing show that the strength of the Oculus™-SA Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This is the extent of the performance information provided.

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