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The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as accuracy, sensitivity, specificity, AUC, human reader improvement, or FROC analysis.

The document is a 510(k) premarket notification from the FDA for the Cascadia Interbody System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed acceptance criteria and performance study results for a new or significantly re-engineered AI/imaging device.

Here's what the document does mention in relation to performance and comparison:

• Non-Clinical Performance Evaluation:
  • It states that "The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion."
  • It also mentions "Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of <20EU/Device."

This information pertains to mechanical and biological safety performance, not the kind of AI/algorithm performance you've asked about (e.g., accuracy, sensitivity, human reader improvement, etc.).

Therefore, I cannot populate the table or provide details about the specific aspects of AI/imaging device evaluation you've requested as that information is not present in the provided text.

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