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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.

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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, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/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 additional components to the previously cleared VERTE-STACK™ Spinal System.

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance results as typically seen for AI/ML-based medical devices or diagnostics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided document. The 510(k) summary is a regulatory submission demonstrating that a new device is as safe and effective as an existing, legally marketed device (predicate device). It does not typically include detailed performance studies with acceptance criteria in the way a clinical trial or a study for a novel device would.

The document states:
"Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System components found in K030736, K030735, K023570 and K021791."

This means the acceptance criteria and performance are implicitly met by virtue of being similar enough to established predicate devices that have already undergone regulatory scrutiny. No new clinical or performance studies are detailed in this summary.

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Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.c. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The Ellys components are kidney shaped and are used in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the space for home graft. The implant is always implanted in the vertical position. These components are available in various heights (8mm-150mm) to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The Aurys components are trapezoidal in cross sccion and are used singly. The interior of these components have three hollow compartments that run the vertically and are provided for the placement of bone grafi. I like the Aurys components are also available in various hcights (9mm-1.50mm) and have angled ends to match the angle of the vertebral endplates. The ends have ridges similar to the Ellys to interface with the vertebral endplates. There are also holes evenly spaced on the medial/lateral surfaces to complete bone graft impaction after insertion.

Both the l'llys and Aurys components are fabricated from pure poly(ether cther ketone) (PEIFA). This material closcly matches the modulus of elasticity of cortical bone, improving the biomechanical interface and reducing the stress shickling clicci. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. Two metal wires at the opposite ends of the spacers allow radiological confirmation of the cage position post operatively.

The provided text describes a medical device, the Ellys and Aurys Vertebral Body Replacements, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for performance, a study proving the device meets those criteria, or any specifics regarding device performance metrics, sample sizes, expert involvement, or ground truth establishment.

The document is a 510(k) premarket notification summary and the FDA's clearance letter. It focuses on:

• Device Description: Physical characteristics, materials, and available sizes of the Ellys and Aurys components.
• Intended Use/Indications for Use: The specific medical conditions and anatomical locations for which the device is intended.
• Equivalent Device: Listing of similar previously cleared devices.
• Nonclinical Tests: A brief mention that "Testing was performed per ASTM F1717." This indicates a standard was followed for mechanical testing, but no results or acceptance criteria are provided in this document.

Therefore, I cannot populate most of the requested table and answer the questions about the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Here's an attempt to answer based on the limited information given, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only mentions "Testing was performed per ASTM F1717" without any details on sample size or specific test results.
• Data Provenance: Not specified. Given the nature of a 510(k) summary for a physical device, testing would typically be in vitro (bench testing) or potentially ex vivo (using cadaveric spines), often conducted by the manufacturer or a contracted testing lab. There is no indication of clinical data or patient data in this submission.

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

• Not applicable. The document describes pre-market notification for a physical medical device, not an AI/software device that would require expert-established ground truth for performance evaluation in the context of image interpretation or similar tasks. Biomechanical testing per ASTM F1717 does not typically involve expert consensus for ground truth.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for studies involving human interpretation (e.g., medical imaging reviews) where discrepancies need resolution. For biomechanical testing, results are typically objective measurements.

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 not an AI/software device. No MRMC study was performed or mentioned.

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

• Not applicable. This is not an AI/software device. No algorithm standalone performance was done or mentioned.

7. The type of ground truth used

• For the nonclinical (biomechanical) testing, the "ground truth" would be the objective measurements obtained according to the ASTM F1717 standard's protocols, compared against performance specifications derived from the standard or predicate devices. This is not the "expert consensus, pathology, or outcomes data" typically associated with AI/diagnostic device ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/software device. There is no mention of a training set.

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

• Not applicable. This is not an AI/software device. There is no mention of a training set or its ground truth establishment.

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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 Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System, the Titanium 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 PEEK 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) as described by ASTM F-1579. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.

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 mav be used individually. or two or more mav 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.

The purpose of this submission is to include additional sizes to the VERTE-STACK™ Spinal System.

This 510(k) premarket notification for the VERTE-STACK™ Spinal System describes a device that is substantially equivalent to previously cleared devices. Therefore, it does not present new acceptance criteria or a study demonstrating device performance against new criteria. Instead, the submission relies on the established equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided for an equivalence submission:

Acceptance Criteria and Study for VERTE-STACK™ Spinal System (K030601)

This submission (K030601) is a 510(k) premarket notification claiming substantial equivalence to previously cleared VERTE-STACK™ Spinal System devices (K023570 and K021791). In such an application, the primary "acceptance criterion" is generally demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness, compared to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided. This is a substantial equivalence claim based on the device's design, materials, and intended use being similar to existing cleared devices. It does not involve a clinical study with a distinct "test set" of patients or data in the way an AI/software device would. The "test" is the comparison to the predicate device and relevant standards.

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

• Not applicable / Not provided. Given that this is a product submission for a physical medical device (spinal implant) based on substantial equivalence, there is no "ground truth" derived from expert interpretation of data in the manner of an AI diagnostic device. The "ground truth" is typically established by engineering design, material specifications, and performance testing against recognized standards.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. As there is no "test set" in the context of expert review for diagnostic accuracy, no adjudication method is relevant here.

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 submission is for a physical spinal implant, not an AI or software-as-a-medical-device (SaMD). Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

• Engineering Specifications and Standard Compliance: The "ground truth" for this type of device relies on established engineering principles, material specifications (e.g., ASTM F-1579 for PEEK, ASTM F-560 for Tantalum), and a demonstration that the device's design and intended performance are safe and effective, typically through mechanical testing and validation of material properties. For a substantial equivalence claim, the primary "ground truth" is the previously cleared predicate devices and the accepted safety and effectiveness established for them.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This is not an AI/ML device where a training set size would be relevant. The "training" for such a device is in its design, manufacturing processes, and adherence to quality systems.

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

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML workflow. For a physical device, the "ground truth" for its design and manufacturing is established through adherence to recognized standards, quality control, and pre-clinical testing that establishes its safety and performance characteristics.

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