Search Results

The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.

The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Reliance VBS System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously marketed devices, often through comparison of design, materials, and intended use.

*Crucially, this document does not describe acceptance criteria, performance metrics, or any study results typical of an AI/ML or diagnostic device.

The Reliance VBS System is a spinal implant (a spacer to replace a portion of a vertebral body). Its "performance" is primarily assessed through its design, materials, and mechanical properties, not through a clinical study that would have a "test set," "ground truth," or "expert readers" in the way one might evaluate an AI-powered diagnostic tool.

Therefore, I cannot provide the requested information in the table or the detailed points about studies, sample sizes, and ground truth establishment, as these concepts are not applicable to the information contained in this 510(k) summary for a physical orthopedic implant.

The document states:

• Device Description: The Reliance VBS device is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. It may be made of PEEK with Tantalum markers, or made of Titanium alloy.
• Intended Use/Indications for Use: For use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression, restore height, and biomechanical integrity. It is to be used with a cleared supplemental fixation device and bone graft.
• Substantial Equivalence: The device is stated to be substantially equivalent to several legally marketed predicate devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.

To reiterate, this is a hardware device approval, not a software or AI approval. Therefore, the concepts requested in the prompt (acceptance criteria for a study, device performance results, sample sizes for test/training sets, ground truth, expert adjudication, MRMC comparative effectiveness studies, and standalone algorithm performance) are not present in this type of regulatory submission and are not relevant to the approval of this spinal implant.

Ask a specific question about this device

The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5). It is intended to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The device is intended for use with supplemental fixation systems such as Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

The provided document is a 510(k) summary for the Stryker Spine Vertebral Spacer. It discusses the device's intended use, materials, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device met those criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML device evaluations.

The "study" referenced in this document is a technological comparison and mechanical testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s. This is a very different type of "study" than what would be conducted to evaluate the performance of an AI/ML powered medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the format typically used for AI/ML device evaluations, because this document predates such rigorous performance evaluation requirements for AI/ML devices and describes a different type of medical device (an implant, not an algorithm).

However, I can extract information relevant to the device's regulatory acceptance based on the document.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Inferred from regulatory context, not explicit numerical targets):

  • Substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
  • Compliance with FDA's Guidance for Spinal System 510(k)'s, September 27, 2000.
  • Mechanical and biological safety and effectiveness demonstrated through testing (though specific test results are not detailed).

• Reported Device Performance: The document states that the "Stryker Spine Vertebral Spacer is substantially equivalent to its predicate devices." This is the primary reported "performance" metric in a 510(k) context. Specific quantitative performance data (e.g., in terms of strength, fatigue life, biological compatibility) from the underlying testing mentioned by the company is not provided in this summary.

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

• Not Applicable in the AI/ML sense. This document pertains to a physical implant. The "test set" would typically refer to the samples used in mechanical testing (e.g., number of implants tested for compression, fatigue, etc.) or in-vitro/in-vivo biocompatibility studies. This information is not provided in the 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The "data" here would be from mechanical and biocompatibility testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This device is a physical implant, not an AI/ML algorithm requiring expert interpretation of outputs.
• The FDA reviewers (e.g., Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices) are experts involved in the regulatory approval process, but they are not establishing ground truth for evaluating an algorithm's performance.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to resolving discrepancies in expert interpretations for AI/ML ground truth.

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

• Not applicable. This type of study focuses on the impact of an AI algorithm on human reader performance.

6. Standalone Performance:

• Not applicable in the AI/ML sense. The "device" itself (the vertebral spacer) has standalone performance in terms of its mechanical properties and biocompatibility, but this is not typically expressed in terms of metrics like sensitivity/specificity for an algorithm. The 510(k) process ensures the device itself is safe and effective when used as intended.

7. Type of Ground Truth Used:

• For a physical implant, the "ground truth" for its performance would be established through a combination of:
  • Mechanical Testing Standards: Adherence to established industry standards for strength, fatigue, etc.
  • Biocompatibility Testing: In-vitro and sometimes in-vivo studies to assess material safety.
  • Clinical Literature/Experience: Relying on the known performance and safety profiles of similar predicate devices.
• The 510(k) summary indicates compliance with FDA's Guidance for Spinal System 510(k)'s. This guidance would outline the necessary tests and criteria to establish "ground truth" for mechanical and biological safety.

8. Sample Size for the Training Set:

• Not applicable. This is an AI/ML specific term.

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

• Not applicable. This is an AI/ML specific term.

In summary, the provided document is a regulatory submission for a physical medical device (vertebral spacer) and addresses "substantial equivalence" to predicate devices rather than the performance metrics typically associated with AI/ML systems. The "study" mentioned refers to engineering and compliance testing against established guidance for spinal implants, not a clinical performance study using a test set of data as would be done for an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

The VERTE-STACK™ Spinal System 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 VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include a titanium version of previously cleared VERTE-STACKTM Spinal System components.

The provided text describes a 510(k) submission for the VERTE-STACK™ Spinal System, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with acceptance criteria in the same way a PMA (Pre-Market Approval) study would.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not typically part of a 510(k) submission document like this. The primary "study" in a 510(k) is a comparison to a predicate device.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study for the VERTE-STACK™ Spinal System. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) for a spinal implant. There is no "test set" in the sense of a patient cohort or imaging dataset used to evaluate an algorithm. The evaluation is primarily based on comparison to predicate devices and engineering/material data (which are not detailed in this summary).
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth establishment with experts is typical for diagnostic algorithms, not for spinal implants in a 510(k) submission.

4. Adjudication method for the test set

• Not applicable. There was no test set requiring expert adjudication.

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 is a medical device (spinal implant), 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 is a medical device (spinal implant), not an algorithm.

7. The type of ground truth used

• The "ground truth" for a 510(k) for a medical device like this is the established safety and effectiveness of its predicate devices, backed by clinical use and regulatory clearance. The basis of comparison focuses on material properties, design specifications, and indications for use.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable.

Ask a specific question about this device