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The Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the lumbar spine (L2 to S1), and are intended to be used with autogenous bone graft and supplemental fixation systems that have been cleared by the FDA for use in the lumbar spine.

The proposed devices within the Coalesce™ Lumbar Interbody Fusion System are sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the lumbar spinal column in lumbar intervertebral body fusion procedures. Each device within the Coalesce™ System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.

The provided text describes a medical device, the Coalesce™ Lumbar Interbody Fusion System, and its clearance process with the FDA. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. The "testing" mentioned is primarily performance testing against engineering standards for intervertebral body fusion devices, not clinical studies with human participants or evaluation of algorithm performance in an AI context.

Therefore, I cannot provide the requested information. The text does not report:

1. A table of acceptance criteria and reported device performance related to diagnostic or evaluative metrics.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Number or qualifications of experts to establish ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used in a clinical or AI context.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Non-Clinical Testing" section (I) describes:

• Functional performance testing: static and dynamic compression, compression shear, subsidence, and expulsion.
• Standards referenced: (ASTM) F2077-14, (ASTM) F2267-04, and (ASTM) F1877-16.
• Conclusion: "Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices."

This indicates that the device met the requirements of these engineering standards, which likely have their own defined acceptance criteria (e.g., maximum deformation under load, minimum load to failure). However, these specific criteria and the detailed results showing compliance are not included in the summary.

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