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The Spinal USA VBR System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

The Spinal USA VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column

The Spinal USA VBR System is intended to be used with supplemental spinal fixation systems that have been cleared 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). In addition, the Spinal USA VBR System is intended for use with bone graft.

The Spinal USA VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system consists of a straight, curved, round, and trapezoidal implants. The various implants via shallsin, curved, curved, curved, the individual patient anatomy. All components are made from medical grade titanium or titanium or titanium or titanium or titanium or titanium or titanium or titanium or tit alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

This document is a 510(k) summary for the Spinal USA VBR System, a vertebral body replacement device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than a detailed performance study with acceptance criteria in the typical sense of AI/software devices. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not available in the provided 510(k) summary. For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This is typically shown through:

• Materials testing: Ensuring the device materials meet established standards (e.g., biocompatibility, mechanical properties).
• Mechanical testing: Demonstrating that the device performs equivalently or better than predicate devices under specified biomechanical loads.
• Design similarities: Highlighting that the device's design and intended use are similar to predicate devices.

The document states: "Testing in accordance with ASTM F2077-03 'Test Methods for Intervertebral Body Fusion Devices' of the Spinal USA VBR System demonstrates that the device is substantially equivalent to the Novel VBR Spinal System (K042201), Lanx VBR System (K052384), Depuy Acromed Stackable Cage (K990148), Quantum VBR Quantum Orthopedics(K050449), PEEK Tetris Signus Medical (K031757), CO VBR Scient X(K050348), Ellys and Aurys VBR Scient'X (K033109)."

This statement implies that the device met the performance requirements outlined in ASTM F2077-03, which serves as the "acceptance criteria" for mechanical performance, to establish substantial equivalence. However, the specific quantitative criteria (e.g., "withstanding X N of compression for Y cycles") and the exact performance results are not reported in this summary.

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 in the context of a mechanical device 510(k) submission like this. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of patient images or clinical outcomes. Data provenance for such mechanical testing typically relates to the lab where tests were conducted, not country of origin of patient data.

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 is not applicable. Ground truth in the context of mechanical device testing refers to established engineering specifications, material standards, and biomechanical principles, not expert medical opinion on images or clinical cases.

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

This is not applicable for mechanical 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

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

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

This is not applicable. This document describes a physical medical implant, not an AI or diagnostic imaging device.

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

The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biomechanical testing protocols. The device's ability to maintain spinal stability and integrity, as well as its material properties, are objectively measured against these predefined standards. For instance, the ASTM F2077-03 standard specifies methods for evaluating intervertebral body fusion devices, and conformance to this standard serves as a form of "ground truth" for mechanical performance.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

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

This is not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant.

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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.

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