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

The modified 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, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Salvo™ Spine System.

This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of design, materials, and performance testing data (e.g., mechanical tests like dynamic axial compression bend testing and static pull apart testing) to ensure the changed device meets existing standards. It does not typically involve:

• AI/Human-in-the-loop performance studies: The device is a thoracolumbosacral pedicle screw system, which is a physical implant, not an AI or software device.
• Acceptance criteria related to AI performance: There are no metrics like accuracy, sensitivity, specificity, or reader improvement to report.
• Sample sizes for AI training/test sets or ground truth establishment: These concepts are not applicable to a physical surgical implant.
• Expert adjudication or multi-reader multi-case studies: These are relevant for diagnostic devices interpreting medical images or data, not for orthopedic implants.

Therefore, I cannot extract any information related to acceptance criteria, study design, expert involvement, or AI performance as requested in your prompt. The document only confirms the device's clearance based on mechanical performance data demonstrating substantial equivalence to a predicate device.

Ask a specific question about this device

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, and cobalt-chromium alloy per ASTM F1537. The Salvo™ Spine System consists of a variety of screws, rods, and cross-connectors that create a rigid construct as an adjunct to fusion for internal fixation and stabilization of the thoracic, lumbar, and sacral spine.

This document describes the FDA's 510(k) clearance for the Salvo™ Spine System, a thoracolumbosacral pedicle screw system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone study proving novel acceptance criteria for an AI/CAD system. Therefore, I cannot provide information on AI/CAD specific acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies as these are not relevant to this type of device clearance.

Here is the information directly available from the document regarding the acceptance criteria and study, interpreted for a non-AI medical device:

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

Note: The document states "Nonclinical testing was performed on the Salvo™ Spine System to support substantial equivalence to the predicate devices." Implied acceptance criteria for these tests would be that the Salvo™ Spine System performs comparably to or better than the predicate devices under these specific mechanical assessments, or meets predetermined minimum performance standards for spine implants.

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

The document does not specify the sample sizes (number of devices/components tested) for the nonclinical benchtop tests. It also does not mention data provenance as these are mechanical tests performed on manufactured devices, not clinical data sets from patients.

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. Ground truth and expert review are not relevant for mechanical benchtop testing of a pedicle screw system. The "ground truth" for these tests are the physical measurements and standards defined by the ASTM protocols themselves.

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

Not applicable. Adjudication methods are relevant for human interpretation tasks, not for mechanical 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

No. This document describes the clearance of a physical medical device (spinal implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.

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

No. This is not an AI algorithm; it is a physical implant.

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

The "ground truth" for the performance data presented (nonclinical testing) is based on the standardized test methods outlined in ASTM F1717 and ASTM F1798. These standards define the parameters and methods for evaluating the mechanical properties of pedicle screw spinal systems.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a 510(k) submission for a physical medical device.

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

Not applicable. As above, there is no training set mentioned or relevant to this type of device clearance.

Ask a specific question about this device