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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; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, 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; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Salvo® Spine System is a thoracolumbosacral pedicle screw system designed through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V EL) per ASTM F136, commercially pure titanium per ASTM F67, cobaltchromium alloy per ASTM F 1537, and PEEK-OPTIMA LT1 with BaSO4. The System consists of a variety of screws, rods, and connectors that create a rigid construct as an adjunct to fixation and stabilization of the thoracic, lumbar, and sacral spine.

The provided text describes the 510(k) premarket notification for the Salvo® Spine System, a medical device. It does not contain information about a study proving that the device meets acceptance criteria related to an AI-driven or diagnostic system. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance metrics of an AI model or a new diagnostic tool.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) as the document does not contain this type of data. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "Nonclinical testing was performed on the Salvo® Spine System to support substantial equivalence to the predicate device. Dynamic axial compression bending testing per ASTM F1717 was performed."
• "Clinical testing is not applicable."

This indicates that the device's clearance is based on mechanical testing and comparison to existing devices, not on a study involving human readers, AI assistance, or the establishment of diagnostic thresholds.

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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.

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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; dislocation; 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 ELI) per ASTM F136, commercially pure titanium per ASTM F67, cobalt-chromium alloy per ASTM F1537, and PEEK-OPTIMA LT1 per ASTM F2026. 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.

This FDA 510(k) clearance letter and summary are for a spinal implant system (Salvo® Spine System), not an AI/ML medical device. Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance in terms of AI metrics, sample sizes for AI training/test sets, ground truth establishment, MRMC studies) is not applicable or present in the provided text.

The document describes the Salvo® Spine System as a thoracolumbosacral pedicle screw system, which is a physical implant used in spinal fusion surgery. The "performance data" section refers to nonclinical (mechanical) testing of the implant itself, to ensure its structural integrity and comparability to a predicate device.

Therefore, I cannot provide the requested information based on the given text.

If you have a document related to an AI/ML medical device, please provide that, and I will be happy to extract the relevant details.

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