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SPIRA® Posterior Lumbar Spacers (SPIRA®-P Posterior Lumbar Spacer, SPIRA®-T Oblique Posterior Lumbar Spacer, and SPIRA®-TA Posterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis), and failed previous fusion (pseudoarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. SPIRA® Posterior Lumbar Spacers are intended to be used with additional FDA-cleared supplementary fixation systems. SPIRA® Posterior Lumbar Spacers are intended for use with an autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The Camber Spine Technologies SPIRA® Posterior Lumbar Spacers are lumbar interbody fusion devices that have an open matrix design to permit packing with autogenous graft material to facilitate fusion. The subject submission seeks to expand the indications of the existing SPIRA® Posterior Lumbar Spacers (SPIRA®-P and SPIRA®-T) as well as add the subject SPIRA®-TA components to the Camber Spine Technologies SPIRA®-TA Posterior Lumbar Spacer allows the interbody fusion device to be inserted from a transforaminal approach. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The device contains a rotating pin that allows for articulation to accommodate the surgical approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.

Camber Spine Technologies SPIRA®-TA device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (locking cap and pivot pin) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

I am sorry, but the provided text is a 510(k) summary for a medical device (SPIRA® Posterior Lumbar Spacers), which is a regulatory document addressing the substantial equivalence of the device to existing predicate devices.

This document focuses on:

• Device Description and Indications for Use: What the device is and what it's used for.
• Substantial Equivalence: How it compares to already cleared devices.
• Performance Testing (Mechanical): Mechanical tests performed to ensure the device's physical properties are comparable.

Crucially, this document does NOT contain information about:

• AI/Algorithm Performance: There is no mention of any AI or algorithm being part of this medical device. The device is a physical interbody fusion spacer.
• Ground Truth Establishment: This would be relevant for evaluating an AI, not a physical implant.
• Human Reader Studies (MRMC): These are performed to assess the impact of AI on human interpretation, which is not applicable here.
• Standalone Algorithm Performance: No algorithm is discussed.
• Training Set/Test Set Details: These are relevant for AI model development and validation, not for physical implants.

Therefore, I cannot provide the detailed information requested in your prompt as it pertains to the acceptance criteria and study proving an AI device meets those criteria. The provided text describes a physical Class II medical device (lumbar spacer) and its mechanical performance testing for FDA clearance, not an AI-powered diagnostic or assistive technology.

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