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The Integrity Spine Lumbar Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach:
• as a single device via a transforaminal (TLIF) approach; or
• as as a single device via an anterior or anterolateral (ALIF) approach.
  The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
  The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

This document is a 510(k) premarket notification for the Integrity Spine Lumbar Interbody Fusion System. It is an FDA clearance letter and a 510(k) summary, not a study report proving a device meets acceptance criteria. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for evaluating device performance in the context of AI or diagnostic accuracy studies.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical mechanical testing for safety and performance in a physical device context (interbody fusion).

Therefore, I cannot extract the requested information from this document. The document discusses:

• Device Name: Integrity Spine Lumbar Interbody Fusion System (Page 2)
• Intended Use: Intervertebral body fusion of the lumbar spine, from L2 to S1, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, for skeletally mature patients who have had six months of non-operative treatment. (Page 2)
• Testing: Non-clinical mechanical testing including static and dynamic compression, static and dynamic torsion, subsidence, and expulsion testing. These tests were conducted according to ASTM standards (F2077-11, F2267-04, and a Draft Standard F-04.25.02.02). (Page 5)
• Conclusion: The device is substantially equivalent to predicate devices based on shared intended use, implant design, material, and non-clinical mechanical test results. (Page 5)

The prompt asks for acceptance criteria and study details that are typically found in studies evaluating diagnostic devices, AI algorithms, or clinical performance. This document pertains to a surgical implant and its mechanical properties.

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