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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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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, kyphosis, 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 (L1 - 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 FORTIS and HANA Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for HANA and one, two, three, and four level procedures for FORTIS. Main plate is available from 13mm to 46mm for HANA and 10mm to 112mm for FORTIS. Screws are available in lengths from 12mm to 20mm for HANA and 10mm to 20mm in 2mm increments for FORTIS. The screws have either a 4.5mm or 5.1mm diameter for HANA and 4.0mm or 4.5mm diameter for FORTIS. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS and HANA Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also preassembled to the main plate and designed to assemble the subplate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed selfdrilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments. The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.

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 provided document is a 510(k) summary for the FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System. It explicitly states that the subject and predicate devices are identical, and therefore, no performance testing was required.

Because no performance testing was conducted, there are no acceptance criteria or studies to describe as per your request related to device performance. The submission is solely for transferring the name of a system that has already been cleared under previous 510(k) numbers (K121862, K173099, K200846, and K213820).

Therefore, answering your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable, as no performance testing was done.
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance testing was done.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was done.
4. Adjudication method for the test set: Not applicable, as no performance testing was done.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a spinal implant system, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance testing was done.
8. The sample size for the training set: Not applicable. This device is a spinal implant system, not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This device is a spinal implant system, not an AI/ML device.

Ask a specific question about this device

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, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one, two, three, and four level procedures. Main plate are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed self-drilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments

The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

The provided text is a 510(k) summary for the Rex Anterior Cervical Plate System. It describes the device, its intended use, and its performance data, primarily focusing on its substantial equivalence to predicate devices.

However, the document does not contain information related to a study proving the device meets acceptance criteria in the context of AI/ML performance, such as sensitivity, specificity, or F1 score. The performance data mentioned refers to mechanical tests (static compression, torsion, and fatigue) performed according to ASTM F1717 to characterize the physical properties of the cervical plate components.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to AI/ML device performance. The document focuses on regulatory approval for a physical medical device based on material, design, and operational principles, and substantial equivalence to existing predicate devices.

Here's what I can extract from the provided text, acknowledging the lack of AI-specific performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information, there is no mention in the provided text for:

• Sample size for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any AI/ML model.
• How ground truth for the training set was established.

This document is a 510(k) summary for a spinal implant, which is a hardware device, not an AI/ML software device. The "performance data" refers to the physical and mechanical characteristics of the plate system.

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