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The XIA® 4.5 Spinal System is intended for anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e. fracture of dislocation)
• · Spinal Stenosis
• · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• · Tumor
• · Pseudarthrosis
• · Failed Previous Fusion

The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.

Indications for Use (Power):
The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is intended for anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.

The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolysis, fracture caused by tunor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MANTIS® Spinal System, MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative dise disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is comprised of Monoaxial, Polyaxial and reduction bone screws, Cortical Trajectory (CT) bone screws (cannulated and non-cannulated), hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, growth connectors, and cross connectors to vertebrae of the spinal column.

The subject submission will introduce line extension of non-cannulated dual lead self-tapping Xia® Cortical trajectory (CT) bone screws, sub components of existing XIA® 4.5 Spinal System. Ø5.5, Ø 6.5, and Ø7.5 with a length of 35mm-70mm screws are to be added. The new components will be used in the same manner as the predicate XIA® 4.5 Spinal System.

The Xia® 4.5 Spinal System, including the new Xia® Cortical Trajectory implants, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument. The Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, are used with Stryker Spine Power Adaptor to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws.

The provided text describes a 510(k) premarket notification for the Stryker XIA® 4.5 Spinal System and Power Adaptor Instrument Accessory, which is a spinal fixation device.

Crucially, this document is a regulatory submission for a medical device (spinal system) and an accessory. It is NOT a study describing the performance of an AI/ML-based medical device against specific acceptance criteria for diagnostic or prognostic tasks.

Therefore, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "sample size for training set." These concepts are specific to the validation of AI/ML algorithms, not conventional spinal instrumentation.

The document discusses substantial equivalence to predicate devices based on design features, materials, and intended use, rather than a performance study against statistical acceptance criteria for an algorithm.

Based on the provided text, the device in question is a spinal system, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI/ML study, ground truth, expert opinions, etc.) is not applicable and not present in this document.

If you have a document describing an AI/ML device's performance study, I would be happy to analyze it for the requested criteria.

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