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The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The BALTEUM™ and BALTEUM-ONE™ Lumbar Plate Systems are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (11 - S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Osprey™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The FORTIS and HANA Anterior Cervical Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the cervical spine (C2-C7) through an anterior approach. The systems include instrumentation which assists in the surgical implantation of the device. The implants are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Rex Cervical Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the cervical spine (C2-C7) through an anterior approach. The systems include instrumentation which assists in the surgical implantation of the device. The implants are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an anterolateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device. The implants are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Osprey™ Anterior Cervical Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the cervical spine (C2-C7) through an anterior approach. The systems include instrumentation which assists in the surgical implantation of the device. The implants are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

The provided document is a 510(k) summary for several spinal plate systems, including FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System.

It states that "non-clinical testing was performed to demonstrate that the subject Osprey™ Anterior Cervical Plate System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717:

• Static compression
• Dynamic compression
• Static Torsion"

For the other devices (FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System), the submission claims they are "only transferring name of a system that has already been cleared under K222572" and are "identical to the predicate devices, no performance testing is required."

This submission does not contain the specific acceptance criteria and detailed performance results that are usually found in a comprehensive study report. It only mentions the types of tests performed and the standard followed. It does not provide quantitative acceptance criteria or reported performance values such as load, displacement, stiffness, or cycles to failure.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.

Furthermore, this document describes a mechanical performance study based on ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model). It does not appear to be a study involving human or animal data, expert interpretation, or AI performance. As such, the following requested information is not applicable and cannot be extracted from this document:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

In summary, the provided document describes a mechanical bench-top testing study to establish substantial equivalence for a medical device. It does not contain information related to software/AI performance, clinical study data, or expert ground truth adjudication.

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