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The ALIF STS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. 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 non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment with the devices. The devices. The device should be used with supplemental fixation.

The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.

The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in 6 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 16mm in 1mm increments.

The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.

The provided document is a 510(k) summary for the 4Web Spinal Implant Products, which are medical devices. It details the product, its indications for use, and a comparison to predicate devices, focusing on changes related to packaging and sterilization.

However, this document does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML evaluation metrics (like sensitivity, specificity, or image-based performance). The "acceptance criteria" and "performance" described in this document refer to the physical and biological integrity of the manufactured device, its packaging, and its sterilization, as well as its mechanical properties and biocompatibility.

Specifically, the document states:

• Purpose: "The purpose of this submission is to gain clearance of previously cleared devices as sterile, packaged products."
• Conclusion: "The packaging and sterilization processes have been properly validated and raise no new questions of safety or effectiveness."

The performance standards listed are for:

• Gamma sterilization per ANSI/AAMI/ISO 11137-2
• Packaging per ISO 11607-1
• Package integrity tests per ASTM F88-09, ASTM F1886-09 and ASTM F1929-12
• Shipping performance per ASTM D4169-09
• Shelf life tests per ASTM F1980-07

These are standards related to the manufacturing, packaging, and shelf-life of the physical implant, not diagnostic performance or AI model performance.

Therefore, I cannot provide the requested information in the format specific to AI/ML device evaluation, as it is not present in the provided text. The document is about a hardware medical device (spinal implants) and its regulatory clearance based on substantial equivalence for manufacturing and processing changes (sterile packaging), not a software or AI/ML device requiring performance metrics like accuracy, sensitivity, or a comparative effectiveness study involving human readers.

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