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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 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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