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The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis). spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The SPIRA® Anterior Lumbar Spacers are intended to be used with additional FDAcleared supplemental fixation systems. The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers system must be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

The Camber Spine Technologies SPIRA-A Integrated Fixation System is indicated for use at one or more levels from L1-S1 as an adjunct to fusion in skeletally mature patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The Camber Spine Technologies SPIRA-A Integrated Fixation System spacers must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These devices are intended to be used with or without three screws and/or anchors which accompany these implants. These spacers are intended for use with additional FDA-cleared supplemental fixation. In addition, these spacers are intended for stand-alone use in patients with DDD at one or two contiguous levels only when ≤20° lordotic implants are used with three screws per implant. Other configurations of this system are not intended for stand-alone use and must be used with additional FDA-cleared supplemental fixation.

The Camber Spine Technologies SPIRA® Anterior 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® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF and SPIRA® Open Matrix LLIF). Additionally, this submission seeks to expand the anterior lumbar spacer options by adding the subject SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers components to the SPIRA® Anterior Lumbar Spacers as well as add the SPIRA®-A Integrated Fixation System.

The Camber Spine Technologies SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers are interbody fusion devices with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implants may be inserted from an anterior oblique lateral 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 implants are available in a variety of sizes to accommodate varies patient anatomies.

The Camber Spine Technologies SPIRA®-A Integrated Fixation System is an anterior lumbar interbody fusion device that has an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion as well as additional fixation options to secure the idsc space. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place, and structural arched to help distribute load across the joint space. The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. Patients with previous non-fusion spinal surgery at the treated level may be treated.

Camber Spine Technologies SPIRA® Anterior Lumbar Spacers, SPIRA®-A Integrated Fixation System blocker screws, and bone anchors are additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001. The SPIRA®-A Integrated Fixation System bone screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

The provided text is a 510(k) summary for the Camber SPIRA® Anterior Lumbar Spacers. It details the device, its indications for use, and a comparison to predicate devices, but it does not contain information related to software, AI, or diagnostic performance criteria as typically found in studies for such devices. Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I populate the other requested fields related to AI/software performance studies.

The document focuses solely on the substantial equivalence of the SPIRA® Anterior Lumbar Spacers, SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers, and SPIRA®-A Integrated Fixation System to previously cleared predicate devices based on design, indications for use, materials, and mechanical performance testing.

Here's what I can extract from the provided text regarding performance testing, even though it doesn't align with the requested AI/software performance criteria:

Performance Testing Details (Mechanical, not AI/Software):

The document mentions mechanical testing performed on the SPIRA®-A Integrated Fixation System, and Finite Element Analysis and geometric comparisons for the SPIRA®-O devices.

• Mechanical Testing for SPIRA®-A Integrated Fixation System:

  • Static and dynamic compression shear per ASTM F2077
  • Static and dynamic axial compression per ASTM F2077
  • Subsidence per ASTM F2267
  • Expulsion
  • Static and dynamic bending per ASTM F2193
  • Anchor impaction testing

• Analysis for SPIRA®-O devices:

  • Finite Element Analysis
  • Geometric comparisons to the predicate

Results of Performance Testing:

"The results all tests and analysis have shown the subject devices to be substantially equivalent to the predicate interbody devices."

"testing shows that the subject SPIRA®-A Integrated meets or exceeds the values of previously cleared devices."

Reasoning for not fulfilling the request completely:

The request is primarily focused on AI/software device performance criteria and studies, which would typically include metrics like sensitivity, specificity, AUC, human reader performance, ground truth establishment, training set details, etc. The provided 510(k) summary is for a physical medical device (intervertebral body fusion device) and focuses on demonstrating substantial equivalence through mechanical testing and design comparisons, not AI or software performance. There is no mention of an algorithm or AI assistance in the provided text.

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