Search Results

PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.

PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.

SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.

PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) premarket notification for an intervertebral body fusion device. While it describes the device, its indications for use, and a basis for substantial equivalence, it does not include the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance against those criteria.

Specifically, the document mentions:

• Mechanical testing (static compression-shear and torsion) in accordance with ASTM F2077 to demonstrate substantial equivalence to predicate spacers.
• Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011.
• Clinical literature being provided in the submission to support additional indications.

However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only states that testing was conducted "to demonstrate substantial equivalence."
2. Sample size used for the test set or data provenance for any clinical study.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Details of a standalone (algorithm-only) performance study. The device is a physical implant, not an AI algorithm.
7. The type of ground truth used (e.g., pathology, outcomes data), as no specific clinical study is described in detail.
8. Sample size for the training set. There's no mention of a "training set" as this is not an AI/machine learning device.
9. How ground truth for the training set was established. (Not applicable for this type of device).

The document is a regulatory submission for a physical medical device (intervertebral body fusion spacers), not an AI/software device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader studies with ground truth established by experts.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

XPand® Corpectomy Spacers (including XPand®-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectorny Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All XPand® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

NIKO® Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All NIKO® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R) are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as vertebral body replacement devices, SUSTAIN® Spacers (including SUSTAIN® R TPS) are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal frave been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

COALITION® Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, depending on the system.

The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® TPS Spacers are stand-alone interbody fusion devices intended for use at one level of the cervical spine (C2-T1) and are to be used with two titanium alloy screws which accompany the implants. The spacers are to be filled with autogenous bone graft.

PATRIOT® Spacers (including Constitution®, Signature®, TransContinental®, and TransContinental® M) are interbody fusion devices intents with degenerative disc disease (DDD) at one or two continuous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers (including COLONIAL®) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The RISE® Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

LATIS® Spacers are interbody for intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® Plate-Spacers are to be filled with autogenous bone graff material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

INDEPENDENCE® (including INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1), DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone graft composed of cancellous and/ or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation), Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Integrated Spacer and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

Globus Medical's interbody fusion and vertebral body replacement devices are cervical, thoracic or lumbar devices used to provide structural stability in skeletally mature individuals following discectomy, corpectomy or vertebrectomy and may be inserted using an anterior, posterior, lateral or transforaminal approach. The devices are available in various heights and geometric options to accommodate surgical approaches and patient anatomy. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. These devices are to be used in conjunction with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the device.

These devices are made from radiolucent PEEK polymer with titanium alloy or tantalum markers or titanium alloy, commercially pure titanium, titanium alloy, and cobalt chromium molybdenum al. Implants are also available with hydroxyapatite (HA) coating.

The provided document is a 510(k) Premarket Notification from Globus Medical Inc. to the FDA, focusing on updating the labeling for MRI compatibility of various intervertebral fusion and vertebral body replacement devices. It is not a study proving the performance of a device against specific acceptance criteria for a diagnostic AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it pertains to the MRI compatibility of physical implants, not a software algorithm.

However, I can extract the following relevant, albeit limited, information:

Area of Acceptance Criteria and Performance (related to MRI Compatibility):

The document states that MRI testing was performed per specific ASTM standards. While the specific numerical acceptance criteria (e.g., maximum displacement, temperature rise, artifact size) are not explicitly detailed in the provided text, the successful completion of these tests implies that the devices met the relevant acceptance criteria defined by these standards for MRI compatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the MRI testing conducted according to the following ASTM standards:

• ASTM F2052:2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119:2007: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182:11a: Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213:2006: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

The document explicitly states: "No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices." This implies that the results of these ASTM standard tests were deemed acceptable by the FDA for the purpose of updating the MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

   • Acceptance Criteria: Not explicitly stated in numerical terms within the document for each specific test. The acceptance criteria are implicitly those defined by the referenced ASTM standards for MRI safety parameters (magnetic field interaction, heating, artifact size).
   • Reported Device Performance: The document only states that "MRI testing was performed on the subject devices per the following ASTM Standards" and that "No further device performance testing was required." This indicates that the performance met the requirements for MRI compatibility, but specific quantitative results (e.g., measured displacement in Gauss/cm, specific heating in degrees Celsius, or artifact dimensions) are not provided.

   Therefore, a full table with specific numerical criteria and performance cannot be created from this text.

2. Sample sized used for the test set and the data provenance:

   • Sample Size: Not specified. The testing was done on the "subject devices," referring to the various types of implants listed (FORTIFY®, XPand®, NIKO®, SUSTAIN®, etc.). The number of individual implants tested for each type is not mentioned.
   • Data Provenance: Not explicitly stated. This type of testing (MRI compatibility) is typically performed in a laboratory setting on the physical devices, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is not a study involving human experts establishing ground truth from clinical images. The "ground truth" for MRI compatibility is determined by physical measurements and adherence to engineering standards.

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

   • Not applicable. There's no adjudication process for this type of physical device testing.

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 document is about the MRI compatibility of physical implants, not an AI/ML diagnostic device requiring an MRMC study.

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

   • Not applicable. This is not an AI/ML algorithm.

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

   • The "ground truth" for MRI compatibility is established by the specifications and measurement techniques outlined in the referenced ASTM standards. This involves physical measurements of magnetic field interaction, temperature changes, and image artifacts, not clinical ground truth derived from patients or expert consensus.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set.

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

   • Not applicable. There is no training set.

In summary, this document is a regulatory submission for physical medical devices and their MRI compatibility labeling, not for a software-based diagnostic device. Therefore, most of the questions pertaining to AI/ML device study design parameters are not addressed and are not relevant to the provided text.

Ask a specific question about this device

The Sustain Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Sustain Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Sustain Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.

The Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.

The Sustain Spacer is a vertebral body replacement device. The provided text indicates that its acceptance criteria and performance were established through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided text details mechanical testing and material specifications. This type of testing typically involves physical samples of the device components. The document does not specify the sample size used for the mechanical tests, nor does it explicitly mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Such details are usually found in the full test report, not the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For mechanical testing, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical review. Therefore, this section is not applicable in the context of the provided information, which focuses on mechanical and material properties. The standard mentioned, "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", sets the technical benchmark.

4. Adjudication method for the test set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and their alignment with established engineering standards. Therefore, this section is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The provided information focuses on the mechanical and material equivalence of the Sustain Spacer to predicate devices through engineering testing, not on clinical effectiveness with human readers.

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

This question is typically relevant for AI/software devices. Since the Sustain Spacer is a physical medical implant, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable.

7. The type of ground truth used:

The ground truth used for demonstrating the device's performance is based on engineering standards and specifications. Specifically, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000, and ASTM material standards (F67, F136, F1295) serve as the benchmarks against which the device's mechanical and material properties are measured.

8. The sample size for the training set:

The concept of a "training set" is relevant for machine learning algorithms. Since the data described pertains to mechanical and material testing of a physical implant, a "training set" in the machine learning sense is not applicable.

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

As mentioned above, the concept of a "training set" is not applicable here. The "ground truth" for the device's performance was established by recognized industry standards and guidance documents for spinal implants, which dictate the required mechanical properties and material composition.

Ask a specific question about this device