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When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN®R) Spacers 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems.

When used as a cervical intervertebral body fusion device, the SUSTAIN® and SUSTAIN®R Spacers 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 have had at least six (6) weeks of non-operative treatment. The SUSTAIN® and SUSTAIN®R 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 System.

When used as a vertebral body replacement device, SUSTAIN® and SUSTAIN® R Spacers are 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 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 systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

SUSTAIN® and SUSTAIN® R Spacers are devices that can be used as intervertebral fusion devices or as vertebral body replacement 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. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach.

The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295.

The SUSTAIN® R Spacers are made from radiolucent peek polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

The provided text describes a 510(k) premarket notification for the SUSTAIN® and SUSTAIN® Radiolucent Spacers, which are intervertebral body fusion devices and vertebral body replacement devices. The submission focuses on adding intervertebral indications and making sterile spacers available.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical study on human subjects with a "test set" for the device's performance. Instead, it describes mechanical testing and a claim of substantial equivalence to predicate devices. Therefore, the concepts of "sample size used for the test set" and "data provenance" in the context of clinical data do not apply here. The "test set" for mechanical performance would be the specific number of devices tested in each mechanical test, but this detail is not provided.

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

This information is not applicable as the submission describes mechanical testing and a comparison to predicate devices, not a study involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. This submission is for an implantable spinal device, not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the device is an implantable medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by the engineering standards and specifications outlined in the referenced guidance document ("Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007") and the ASTM standards mentioned for material composition (e.g., ASTM F67, F136). The performance of the device against these objective engineering standards serves as its "ground truth."

For substantial equivalence, the ground truth is the performance and characteristics of the legally marketed predicate devices (PATRIOT® Spacers, SUSTAIN® Spacers, CALIBER™ Spacers, COALITION® Spacers, BAK/Cervical Interbody Fusion System).

8. The Sample Size for the Training Set

This is not applicable, as this is not a machine learning or AI device that requires a training set.

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

This is not applicable for the same reasons as point 8.

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

The Sustain Radiolucent 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 Radiolucent Spacer devices are made from radiolucent polymer and titanium alloy as specified in ASTM F2026 and F136.

The provided 510(k) summary for the Globus Medical Inc. Sustain Radiolucent Spacer details a medical device, not a software algorithm or AI-powered system, therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not applicable.

The document indicates that the device's substantial equivalence is based on its similarity to a predicate device (Globus Sustain Spacer K031302) and highlights mechanical testing according to "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. This implies that the 'acceptance criteria' were met through established biomechanical benchmarks for spinal implants, rather than performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be relevant for AI studies.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these pertain to the evaluation of AI/ML models.

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