Search Results

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