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CONSTRUX Mini PTC Spacer System: The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system (i.e., an anterior cervical plate such as the Orthofix Hallmark Anterior Cervical Plate System). Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

FORZA PTC Spacer System: The FORZA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels. The FORZA Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.

PILLAR SA PTC Spacer System: The PILLAR SA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft. The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. If the physician chooses to use fewer than four of the provided screws then supplemental fixation must be used to augment stability. As an example, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

CONSTRUX Mini PTC Spacer System: The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The CONSTRUX Mini PTC spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.

FORZA PTC Spacer System: The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK core (conforming to ASTM F2026) with two integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system. The FORZA PTC Spacer System implants are provided sterile.

PILLAR SA PTC Spacer System: The PILLAR SA PTC is a standalone intervertebral body implant that is comprised of a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6AI-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The PILLAR SA PTC device is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another. The PILLAR SA PTC is designed to be used as a standalone device, when implanted with accompanying stabilizing screws. The PILLAR SA PTC spacers are provided sterile.

This FDA 510(k) premarket notification describes a set of intervertebral body fusion devices, not a diagnostic AI device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI device cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to predicate devices through similarities in design, materials, and intended use, supported by mechanical performance testing against an ASTM standard.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance for an AI algorithm.
• Details about sample size for a test set, data provenance, or the number/qualifications of experts for ground truth.
• Information on adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect sizes for AI assistance.
• Standalone performance data for an AI algorithm.
• The type of ground truth used (e.g., pathology, outcomes data) in the context of an AI study.
• Sample size for a training set or how ground truth for a training set was established.

The provided text describes mechanical performance testing (Static and Dynamic Axial Compression Test, Static and Dynamic Compression Shear Test, and Static and Dynamic Torsion Test) in accordance with ASTM F2077-14 for intervertebral body fusion devices. These tests are physical evaluations of the device's structural integrity and performance, not a study of an AI algorithm's diagnostic accuracy.

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