Search Results

The Salvo® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537 and PEEK-OPTIMA. The Salvo® Spine System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

The provided text is a 510(k) summary for the Salvo® Spine System, which is a medical device. This type of document is a notification to the FDA of the intent to market a medical device, claiming substantial equivalence to an already legally marketed device.

Crucially, this document focuses on mechanical performance and substantial equivalence to a predicate device, not on AI-driven diagnostic or treatment algorithms that would typically involve acceptance criteria and study designs in the way your request outlines.

Therefore, most of the information you're asking for (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or present in this document.

The "Performance Data" section explicitly states: "The Salvo® Spine System demonstrated substantially equivalent mechanical performance to the predicate device through dynamic compression bending mechanical testing with reference to ASTM F1717 and a risk analysis compared to the predicate device."

Here's what can be extracted based on the 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)

• Not applicable/Provided. The performance data relates to mechanical testing of the physical device, not a test set of data like in an AI study.

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)

• Not applicable/Provided. Ground truth for mechanical testing would involve engineering standards and measurements, not expert clinician consensus on medical images or patient outcomes.

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

• Not applicable/Provided.

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

• No. This is a mechanical device, not an AI diagnostic tool.

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

• Not applicable. There is no algorithm.

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

• For mechanical testing: Reference to ASTM F1717 standards would serve as the "ground truth" for evaluating the mechanical properties like dynamic compression bending. The "risk analysis" would also have its own internal criteria for evaluating safety.

8. The sample size for the training set

• Not applicable/Provided. The device is a physical pedicle screw system, not an AI model requiring a training set.

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

• Not applicable/Provided.

Ask a specific question about this device