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The Quantum Vertebral Body Replacement 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).

This device 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). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

The provided text describes the Quantum Vertebral Body Replacement device and its intended use, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed performance study parameters requested.

The "Performance Data" section merely states: "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use." This is a very general statement and does not provide any specifics about the testing or its results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document is a 510(k) summary, which typically focuses on substantial equivalence to a predicate device rather than detailed performance study results that would include acceptance criteria and specific data.

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The Quantum Vertebral Body Replacement 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).

This device 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). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).

The provided text describes a medical device, the Quantum Vertebral Body Replacement System, and its intended use, but it does not include the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truth establishment, or multi-reader comparative effectiveness studies.

The document is a 510(k) summary for a medical device submitted to the FDA for clearance. It focuses on demonstrating substantial equivalence to a predicate device and includes information about the device's description, intended use, and a statement about performance data.

Here's a breakdown of what can be extracted and what is missing:

What is present in the document:

• Device Identification: Quantum Vertebral Body Replacement System
• Intended Use: To replace a collapsed, damaged, or unstable vertebral body in the thoracic and/or thoracolumbar spine (T1-L5) due to tumor or trauma (fracture), to be used with supplemental spinal fixation systems.
• Performance Data Statement: "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use."

What is missing from the document and therefore cannot be provided in the requested format:

1. A table of acceptance criteria and the reported device performance: The document only states "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use." It does not specify any quantitative acceptance criteria (e.g., minimum strength, fatigue life, displacement limits) nor does it provide reported numerical performance results against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. The "performance data" refers to mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a mechanical implant, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical implant, not an algorithm.
7. The type of ground truth used: For mechanical testing, "ground truth" would be the engineering specifications and validated test methods. The document does not detail these.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI system requiring a "training set."
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on the regulatory clearance process for a mechanical medical device through substantial equivalence to a predicate, rather than providing detailed performance study data against specific acceptance criteria for a diagnostic or AI-based device. Therefore, the majority of the requested information, which pertains to performance studies for software-based or diagnostic devices, is not available in the given text.

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The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device 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). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

The provided text is a 510(k) Summary for a medical device called the "Quantum Vertebral Body Replacement." It describes the device, its intended use, and states that "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use."

However, this document does not contain any information regarding specific acceptance criteria, detailed study designs (including sample sizes, data provenance, expert qualifications, or adjudication methods), or performance metrics beyond a general statement about mechanical testing.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data elements are not present in the provided text.

Based on the provided input, the following information is unavailable:

• A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are listed. The document only states that mechanical testing indicates the device is "capable of performing in accordance with its intended use."
• Sample sized used for the test set and the data provenance: No information on test set sample size or data provenance is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device (a physical implant) would typically rely on mechanical testing rather than expert-established ground truth on images or clinical data in this context.
• Adjudication method for the test set: Not applicable.
• 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, as this is a physical medical implant, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as the evaluation type appears to be mechanical testing.
• The sample size for the training set: Not applicable, as this is a physical medical implant and not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

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The Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic only with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (lordosis, kyphosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.

The Quantum Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine (C2-C7). Plates and screws are available in a variety of sizes to suit the individual pathology and unatomic condition of the patient. The device is manufactured from titanium alloy.

The provided text does not contain detailed acceptance criteria and the results of a study proving a device meets these criteria in the format requested.

The document is a 510(k) summary for the Quantum Anterior Cervical Plate System. It describes the device, its intended use, and states that substantial equivalence was shown to previously cleared devices. Under the "Performance Data" section, it only briefly mentions:

"Mechanical testing indicates that the Quantum Anterior Cervical Plate is capable of performing in accordance with its intended use."

This statement is very general and does not provide:

• Specific acceptance criteria: There are no quantifiable thresholds or targets mentioned for performance metrics.
• Detailed study results: There are no data tables, sample sizes, or methodologies of the mechanical testing.
• Information on ground truth, expert involvement, or comparative studies.

Therefore, I cannot populate the requested table or provide the detailed study information as the input text does not contain it. The document primarily focuses on establishing substantial equivalence to predicate devices, which often relies on comparison of design, materials, and intended use, rather than extensive new clinical or detailed standalone performance studies with specific statistical acceptance criteria.

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

This device 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). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

This 510(k) summary describes a medical device, the "Quantum Vertebral Body Replacement," which is an implantable surgical device, not a diagnostic AI/ML device. Therefore, the traditional acceptance criteria and study designs relevant to AI/ML devices (e.g., sensitivity, specificity, ROC curves, expert ground truth, multi-reader multi-case studies) are not applicable here.

The "Performance Data" section of the document states: "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use." This indicates that the acceptance criteria for this device are based on mechanical performance standards relevant to spinal implants, rather than diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, adapted for a non-AI/ML medical device where possible:

Acceptance Criteria and Device Performance for Quantum Vertebral Body Replacement

1. Table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: Not specified. For mechanical testing of a medical implant, the "sample size" would refer to the number of physical devices tested. The document does not provide this detail.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer (Quantum Orthopedics, Inc.) or a contracted testing facility. The document does not specify the country of origin of the testing. The testing would be considered prospective in the sense that physical new devices are tested to predetermined standards.

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

• This question is not applicable as the "ground truth" for a mechanical implant device is defined by engineering standards and biomechanical properties, not human interpretation or expert consensus in a diagnostic sense. The "experts" involved would be biomechanical engineers or materials scientists who design and conduct the mechanical tests and interpret the results against established performance standards. Their qualifications would involve expertise in materials science, biomechanics, and medical device regulations.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert opinions or interpretations, typically in diagnostic studies. For mechanical testing, results are typically quantitative and compared against engineering specifications, not subject to subjective adjudication in this manner.

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. MRMC studies are designed for diagnostic performance evaluation, especially for AI-assisted interpretation, where human "readers" (e.g., radiologists) interpret "cases" (e.g., medical images). This device is a physical implant, not a diagnostic tool or an AI algorithm.

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

• Not applicable. This device is a physical implant and does not involve an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on established biomechanical engineering standards and specifications for spinal implants. This includes properties like compressive strength, fatigue life, torsional stability, and biocompatibility, as outlined in relevant ASTM/ISO standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/ML evaluation.

8. The sample size for the training set

• Not applicable. The concept of a "training set" is specific to machine learning algorithms. For a physical medical device like this, product development involves design, prototyping, and iterative testing, but not a "training set" in the AI/ML context.

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

• Not applicable, as there is no "training set" in the AI/ML sense for this device. The design specifications and performance goals for the device would have been established based on anatomical considerations, clinical needs, existing predicate device performance, and current engineering standards for spinal implants.

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