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The Mercury® and Overwatch® Spinal Systems are 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. These systems are 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.

These systems are intended to be used with bone graft.

The Spinal Elements Mercury Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatic patients the Mercury and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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 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 Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, set screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6A1-4V (ASTM F136).

The Overwatch Spine System is a multiple component system comprised of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, pedicle screws, set screws, transverse crosslinks, rod connectors, and hooks. When assembled, the components create a rigid structure to provide stabilization and promote spinal fusion. The systems screws are self-tapping and are available with either a cancellous or cortical cancellous dualfix thread design. The tulips are offered in low top, extended tab and tower configurations. All implant components of the Overwatch Spine System are manufactured from Ti-6Al-4V (ASTM F136) and are provided non-sterile for single-use. The system is to be used with bone graft material to facilitate spinal fusion.

This document is a 510(k) Premarket Notification from the FDA for the Mercury® and Overwatch® Spinal Systems. It establishes the substantial equivalence of these devices to previously cleared predicate devices. The information provided outlines the device description, indications for use, and performance data, but it does not describe a study meant to prove the device meets specific acceptance criteria in the way one might for a diagnostic AI device.

Instead, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. The study described is a series of performance tests.

Here's the breakdown of the requested information based on the provided document:

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

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

This document describes performance testing for a medical implant (spinal system), not a diagnostic algorithm. Therefore, the concept of "test set" and "data provenance" for patient data is not directly applicable in the same way.

• Sample Size: Not specified in terms of patient numbers. The "sample size" would refer to the number of devices or components tested in the mechanical performance tests. This information is typically detailed in the full test reports, which are not included here.
• Data Provenance: Not applicable in the context of patient data. The performance tests are laboratory-based mechanical tests.

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. The "ground truth" for this type of device is established through engineering and biomechanical standards (e.g., ASTM standards) and laboratory testing, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic device would.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, particularly for image-based diagnostics. This document is about mechanical performance 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

Not applicable. MRMC studies are for evaluating diagnostic accuracy, particularly in imaging, with and without AI assistance. This document describes the mechanical performance of a spinal implant.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for the performance claims for this device is based on accepted engineering standards (ASTM) for the mechanical and material properties of spinal implants. The device components are manufactured from materials conforming to specific ASTM and ISO standards (e.g., Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3). The performance tests (Static Axial Grip, Dynamic Compression Bending, etc.) are conducted according to these established standards.

8. The sample size for the training set

Not applicable. This device is not an AI model that requires a training set.

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

Not applicable. This device is not an AI model that requires a training set.

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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 ilium. This system is intended for anterior/ateral 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 into 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 screws to help distribute loads placed against the bone. Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136, ASTM F 1472 or ISO 5832-3. 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 Mercury® Spinal System, a medical device, and its regulatory clearance. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical image analysis. Therefore, I cannot provide an answer that addresses the requested points regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The provided text details the following:

• Device Name: Mercury® Spinal System
• Manufacturer: Spinal Elements Inc.
• Regulatory Clearance: K172967
• Device Type: Thoracolumbosacral pedicle screw system
• Intended Use: Immobilization and stabilization of the spine as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Materials: Titanium alloy (Ti-6Al-4V) and Cobalt Chromium alloy (Co-Cr).
• Substantial Equivalence: Claimed to be substantially equivalent to previously cleared Mercury Spinal System predicate devices (K071914, K082353, K083230, K091587, K141372, K151215).
• Performance Data: States that performance testing included Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1717 and ASTM F 1798, and Static and Dynamic Flexion/Extension Testing per ASTM F 1798. It concludes that "All data indicates that the device will perform as intended."

To reiterate, the original text does not contain the information required to answer your specific questions related to AI device performance evaluation.

Ask a specific question about this device