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510(k) Data Aggregation
(30 days)
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):
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Sensitivity ≥ 90% | Not provided in the document. |
| Specificity ≥ 85% | Not provided in the document. |
| AUC ≥ 0.92 | Not provided in the document. |
| Precision ≥ 88% | Not provided in the document. |
| F1-score ≥ 0.89 | Not provided in the document. |
| Time to result < 5 seconds | Not provided in the document. |
Regarding the specific questions for an AI/ML device, based on the provided text, the answer to all is "Not applicable" or "Information not provided," as this document describes a traditional medical implant.
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to "mechanical testing" for a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of AI/ML is not relevant here.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. For a spinal implant, "ground truth" would relate to its physical and material properties meeting engineering specifications.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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