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The AEGIS Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications are:
· 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);
· deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);

• tumor;
  · pseudarthrosis; and
  · previous failed fusion.

The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc discogenic and back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

The ISOLA Spine System when used as anterior thoracic/lumbar screw fixation system, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The BOWTI Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.
The BOWTI Anterior Buttress Staple System is intravertebral body screw fixation/attachment to the T1-S1 spine over one vertebral body extending into the adjacent intervertebral space. Specifically, the device is intended for stabilization and buttressing of bone graft as an aid to spinal fusion. It may be used with other anterolateral or posterior spinal systems.

The DISCOVERY Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
Translaminar Facet fixation: The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint and into the inferior pedicle.
For both methods this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis:
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The EXPEDIUM Anterior System is intended for anterolateral screw fixation of the T4 to L4 levels of the spine, with metal at least 1 cm from a major vessel. The EXPEDIUM Anterior System may be used in either thoracoscopic procedures or open procedures.
The EXPEDIUM Anterior Spine System is indicated for:
· 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:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with metal at least 1cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures.
The FRONTIER Anterior Scoliosis System is indicated for:
· 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:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The KANEDA Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine.
The KANEDA Anterior Scoliosis System is indicated for:
· 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;
• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor:
• · pseudarthrosis; and previous failed fusion.

The KANEDA SR Anterior Spinal System is intended for anterolateral screw fixation to the T10 to L3 levels of the spine. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, tumor, fracture and revision of previous surgery.

The intended levels for treatment with the M-2 Anterior Plate System are from T3 to L3. In order to treat levels from T3 to L3, plate attachment is from T2 to L4. The M-2 Anterior Plate System is intended to treat one motion segment per construct.
The M-2 Anterior Plate System is indicated for:
· 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:
  · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
  • tumor;
• · pseudarthrosis; and previous failed fusion.

The MOUNTAINEER Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The MOUNTAINEER Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion or impinging the spinal cord.

The intended levels for treatment with the PROFILE Anterior Thoracolumbar Plate System are from T1-L5 spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The UNIVERSITY PLATE Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for the attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

The VIPER F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:
Transfacet fixation: The screws are inserted bilaterally through the facet, across the facet joint and into the inferior pedicle.
This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations;
2. Spondylolisthesis;
3. Spondylolysis;
4. Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity;
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

The AEGIS Anterior Plate System consists of an assortment of titanium alloy plates and screws. The plates are uniquely shaped to conform to the anatomy of the anterior spine. They feature screw holes for final fixation to the vertebral bodies.
The ALC Dynamized Fixation System is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The ALC Dynamized Fixation System construct allows continual compression of the bone graft while avoiding hyperextension type forces on the construct.
The Anterior ISOLA Spine System consists of spinal rods, open and closed screws, washers, caps, set screws, and staples.
The BOWTI Anterior Buttress Staple System consists of staples and screws. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation.
The DISCOVERY Facet Screw Fixation System consists of titanium alloy bone screws and washers designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are available in two configurations: fully threaded and partially threaded.
The EXPEDIUM Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The components of the EXPEDIUM Anterior Spine System are designed with anatomic limitations in mind, therefore minimizing the profile of the construct.
The FRONTIER Anterior Scoliosis System is a construct that consists of spinal staples, semi-blunt tip open screws, washers, and 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA Anterior Scoliosis System is a construct that consists of Kass spinal staples, Kass blunt tip open and closed screws, standard Isola open and closed screws and Isola 3/16 inch (4.75mm) diameter spinal rods.
The KANEDA SR Anterior Spinal System is an anterolateral spinal implant system which is used in conjunction with some components of the Isola Spine System. KANEDA SR consists of longitudinal members, spinal anchors and transverse rod couplers. The longitudinal members are 1/4 inch (6.35 mm) diameter smooth spinal rods. The Isola rods can be cut to size during the surgical procedure or Kaneda rods are available in precut lengths. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods and are available in open and closed screw formats. Caps are available to capture the rod onto the open screws. Set screws are used to tighten the screws to the rods. The transverse couplers add stability, contributing to the construct's ability to resist torsional loads.
The M-2 Anterior Plate System is a construct which consists of one plate attached to the lateral aspect of the vertebrae by either four screws or two screws/two bolts. The components of the M-2 Anterior Plate System have been designed with anatomic limitations in mind.
The MOUNTAINEER Laminoplasty System is an implant system that consists of various sizes of plates and screws. The plates are available in the Inline Side-By-Side, and Offset Side-By-Side configurations. The proposed plate devices come in a preformed shape with holes for bone screws. The plates also contain a slot in the middle portion of the plate for allograft or autograft material attachment. The allograft or autograft material is secured to the plate using bone screws that are inserted through the middle slot on the top portion of the plate.
The PROFILE Anterior Thoracolumbar Plate System consists of various lengths of thoracolumbar and high thoracic plates, cancellous screws, cancellous bolts with locking nuts and screws and bone graft screws. The anterior thoracolumbar plates are implanted using two cancellous bolts placed through the plate's bolt slots and fixed with locking nuts and screws, two cancellous screws placed through the plate's threaded screw holes, and an optional graft screw which can be placed through the plate's center slot to provide fixation between the plate and a strut graft if desired. The high thoracic plates are implanted using four to six cancellous screws, placed through the plate's screw holes.
The UNIVERSITY Plate Anterior System plates are fabricated from implant grade titanium alloy. These plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. Three pairs of nested slots allow a wide range of screw and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The UNIVERSITY Plate Anterior System plates are either rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to avoid contact with the common iliac vessels.
The VIPER F2 Facet Fixation System consists of titanium alloy bone screws designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screws to provide optimal bony contact over a range of screw trajectories.

This document describes the 510(k) premarket notification for "AEGIS® Anterior Lumbar Plate System" and several other spinal fixation systems. The purpose of this submission is to obtain clearance for magnetic resonance compatibility labeling for these devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" of devices used for each test. It refers to "the subject devices" and "the devices listed" in K192281, which includes fourteen different spinal fixation systems. It can be inferred that representative samples of each system (or components thereof) were tested.

The data provenance is from non-clinical testing conducted in alignment with ASTM standards. The country of origin of the data is not specified, but the applicant, Medos International SARL, is located in Switzerland, with the submitter (DePuy Synthes Spine) in Massachusetts, USA. The testing would likely have been conducted in a certified testing facility, potentially in either region or a third-party lab. The studies would be considered prospective in the sense that the testing was designed and conducted specifically to generate data for this regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable in this context. The "ground truth" for MR compatibility studies is established by objective measurements based on recognized international standards (ASTM F2213, F2052, F2119, F2182), not by expert consensus on clinical findings or images. These standards define the methodologies and acceptable limits for MR compatibility.

4. Adjudication Method for the Test Set

This information is not applicable. As mentioned above, the data are objective measurements from physical testing, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. The submitted devices are spinal fixation systems, and the submission is for MR compatibility labeling, which involves physical testing, not diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not done. The devices are physical medical implants, not software algorithms or AI systems. The performance studies conducted were physical evaluations of the implants' behavior in an MR environment.

7. Type of Ground Truth Used

The ground truth used for these studies is based on objective physical measurements and adherence to established international standards (ASTM) for magnetic resonance compatibility. These standards define the acceptable physical forces, heating, and artifact levels for a device to be considered safe and compatible in an MR environment.

8. Sample Size for the Training Set

This information is not applicable. The submission concerns traditional medical devices (spinal implants) and their MR compatibility, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned in this context.

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The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.

Nonclinical Test Summary and Implied Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.

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

There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.

8. The sample size for the training set

This information is not applicable. There was no training set involved as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable. There was no training set.

Summary of the Study:

The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.

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