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The Mercury® Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/anterolateral nonpedicle fixation, posterior non-pedicle fixation pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the head of the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

This document describes the 510(k) premarket notification for the MERCURY® Spinal System, which is a medical device. The information provided is primarily focused on regulatory clearance and substantial equivalence to previously cleared devices. It does not contain specific acceptance criteria, detailed study results, or the other specific information requested about an AI device's performance study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and qualifications to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text only mentions "Performance testing included: Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1798" and "Static and Dynamic Flexion/Extension Testing per ASTM F 1798." It then states, "All data indicates that the device will perform as intended." This is a summary statement for a mechanical device's physical performance, not a detailed report of a study proving a diagnostic AI device's performance.

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The Mercury® Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the iltum. This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the head of the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

The provided document, K141372, is a 510(k) premarket notification for the Mercury® Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or comprehensive performance evaluation with AI.

Therefore, the document does not contain the information requested regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The "Performance Data" section briefly mentions:

• Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1798
• Static Compression, Static Torsion, and Dynamic Compression Construct Testing per ASTM F 1717

These are mechanical and materials testing standards for spinal implant systems, not studies involving AI or human interpretation of medical images. The conclusion, "All data indicates that the device will perform as intended," refers to these engineering tests.

In summary, none of the requested information regarding acceptance criteria and study data for an AI/ML medical device can be extracted from this document.

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The Mercury Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws. Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone.

Screws, rods, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.

The provided 510(k) summary for the Mercury Spinal System does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a regulatory submission for premarket notification (510(k)) of a medical device. It focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than providing the type of performance study details requested for an AI/ML device.

Here's why the specific information requested cannot be extracted from this document:

• Device Type: The Mercury Spinal System is a mechanical implant (screws, rods, staples) for spinal fixation, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concept of "accuracy," "sensitivity," "specificity," "reader studies," or "ground truth" as typically applied to AI/ML devices is not relevant in this context.
• Performance Data: The document states, "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use." This is the extent of the performance data description. It implies ISO/ASTM standard mechanical tests (e.g., fatigue, static strength, torsional strength) were performed, but specific acceptance criteria, test results, or study designs are not provided in this summary.
• Clinical Studies: For mechanical implants like this, clinical data (human subjects) is often not required for a 510(k) if substantial equivalence can be demonstrated through predicate devices and bench testing. There is no mention of human clinical trials, and thus no details on patient cohorts, expert readers, or ground truth establishment.

Therefore, I cannot populate the requested tables and sections with information from this document.

To answer your prompt with the provided input, I would have to state that the requested information is not present in the given 510(k) summary, as it pertains to an entirely different type of device and regulatory submission framework.

If you have a 510(k) summary for an AI/ML-powered medical device, I would be happy to analyze that for the requested details.

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The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i e , fracture or dislocation), spinal stenosis, curvatures (1 e , scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1) A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone

Screws, rods, and staples are made from titanium alloy (Tr-6A1-4V) conforming to ASTM F 136 or ISO 5832-3

The devices of this submission are new screw designs and sizes that are being added to the existing system

The provided text describes a 510(k) premarket notification for the Mercury™ Spinal System, a medical device for spinal fixation. It mentions that "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use," but it does not provide specific acceptance criteria or details of a study with performance metrics for software or AI components.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, experts, or AI-related studies. This document pertains to a physical medical device (screws, rods, staples) and its mechanical testing, not a digital health product with AI/ML components.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Cannot provide. The document states "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use," but it does not specify any quantitative acceptance criteria or detailed performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot provide. This information is typically found in detailed study reports, which are not included in this 510(k) summary.

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):

• Cannot provide. This document is about a physical spinal implant, not a diagnostic or AI device that relies on expert-established ground truth from images or other data.

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

• Cannot provide. Not applicable to this type of device and submission.

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:

• Cannot provide. This information is irrelevant as the device in question is a physical spinal implant, not an AI-assisted diagnostic tool.

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

• Cannot provide. Not applicable.

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

• Cannot provide. Not applicable. The "performance" mentioned is mechanical testing.

8. The sample size for the training set:

• Cannot provide. Not applicable as there is no mention of an algorithm or AI model requiring a training set.

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

• Cannot provide. Not applicable.

Ask a specific question about this device

The Mercury Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws. Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone. Screws, rods, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.

The provided text describes the "Mercury™ Spinal System," a medical device, and its 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This document focuses on the regulatory approval process for a physical medical implant, not an AI/ML-based device.

Therefore, the information typically required for describing acceptance criteria and a study proving an AI/ML device meets them (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) is not present in the provided text, as these concepts are not applicable to the traditional mechanical testing and substantial equivalence demonstration for a spinal implant system.

The "Performance Data" section merely states: "Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use." This is a high-level summary and does not provide specific acceptance criteria or detailed study results.

In summary, based on the provided input, it is not possible to fill out the requested table and answer the study-related questions that are specific to AI/ML device evaluations.

However, if we were to reinterpret the request in the context of what would be present for a traditional medical device like this, it would focus on mechanical and material properties. The "acceptance criteria" would typically be derived from recognized standards (e.g., ASTM F1717 for spinal implant constructs) and predicate device performance. The "study" would be mechanical testing.

Hypothetical Interpretation (Not directly supported by the provided text):

If this were an AI/ML device, the table would look something like this, but the data is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical for an AI/ML device):

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The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients. This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Mercury Spinal System." This document primarily addresses regulatory approval and does not contain the detailed study information required to complete your request, such as acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, or MRMC study results.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered comparable to existing devices, but it does not provide the specific performance metrics or the details of the studies that would demonstrate this.

Ask a specific question about this device