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The Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach.

The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.

The Lateral Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft materials.

The Lateral Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text is a 510(k) summary for a medical device called "Lateral Cage System." This type of document focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than explicitly detailing experimental performance data against pre-defined acceptance criteria in the way a clinical trial or AI/ML performance study would.

Therefore, the input document does not contain the information required to populate a table of acceptance criteria and device performance results for the Lateral Cage System, nor does it describe a study proving the device meets such criteria in terms of diagnostic accuracy or a similar measurable outcome.

The "PERFORMANCE DATA" section of the 510(k) summary simply states: "Performance data were submitted to characterize the Lateral Cage System." This is a generic statement and does not provide specifics about what data was collected, what acceptance criteria were used, or the results of any tests. Given the nature of an intervertebral fusion device, the "performance data" would typically refer to non-clinical bench testing (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical performance metrics in terms of diagnostic accuracy or similar AI/ML-related performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. I also cannot provide information for the subsequent points (sample size, experts, adjudication, MRMC, standalone, ground truth type, training set details) as these are not present in the document.

What the document does indicate about performance (though not in the requested format):

• Type of Device: An intervertebral fusion device with bone graft.
• Materials: Manufactured from Carbon Fiber Reinforced Polymer.
• Performance Characterization: Performance data (likely mechanical, material, and biocompatibility testing) was submitted to characterize the system, but the details are not included in this summary. The FDA's clearance (K082128) implies that this "performance data" was deemed sufficient to demonstrate substantial equivalence to predicate devices for the stated intended use.
• Predicate Devices: LUMBAR I/F CAGE System (P960025) and NuVasive CoRoent System (K071795). This suggests the performance characteristics of the Lateral Cage System were compared against these predicates.

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