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The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation and noncervical nonpedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

The Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The Valeo Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

The provided text is a 510(k) summary for the Valeo™ Pedicle Screw System. This document primarily focuses on demonstrating substantial equivalence to predicate devices for a mechanical medical implant, not a diagnostic AI device. Therefore, many of the requested categories about acceptance criteria, study design for AI algorithms, and expert involvement are not applicable or cannot be extracted from this type of regulatory filing.

Here's an analysis based on the information available:

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

The document does not explicitly state quantitative acceptance criteria in terms of device performance metrics (e.g., accuracy, sensitivity, specificity) as would be seen for a diagnostic device. Instead, acceptance for this type of device is based on substantial equivalence to legally marketed predicate devices, primarily demonstrated through mechanical testing and material characterization to ensure performance characteristics are similar and meet recognized standards.

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

This information is not applicable and not provided in the document. The "test set" for a mechanical implant typically refers to specimens subjected to mechanical testing, not a dataset for an AI algorithm. Therefore, details about data provenance (country, retrospective/prospective) are not relevant here.

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)

This information is not applicable and not provided. "Ground truth" in the context of an AI device usually refers to expert-validated labels for a dataset. For a mechanical implant, "ground truth" relates to the physical and mechanical properties of the device, established through standardized testing procedures, not expert consensus on medical images or diagnoses.

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

This information is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data for AI algorithms. For a mechanical implant, testing results are typically evaluated against pre-defined engineering standards, not through adjudications of expert opinions.

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

An MRMC study is not applicable and not mentioned. This type of study is specifically designed for assessing the impact of AI on human reader performance in diagnostic tasks. The Valeo™ Pedicle Screw System is a physical implant, not an AI diagnostic tool.

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

A standalone performance study for an algorithm is not applicable and not mentioned. The device is a mechanical implant and does not involve an algorithm with standalone performance.

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

The "ground truth" for this device is based on engineering standards and material specifications. This includes:

• Mechanical testing results: Demonstrating strength, fatigue life, and other mechanical properties meet relevant ASTM or ISO standards for spinal implants.
• Material properties: Confirmation that the Ti-6A1-4V material conforms to ISO 5832-3 standards.
• Design and functional equivalence: Comparison of the device's design and intended function to legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a mechanical implant.

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

This information is not applicable and not provided. As there is no training set for a mechanical implant, the method for establishing its ground truth is irrelevant.

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The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to L5 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

The Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium allov components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The ValeoTM Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

This document is a 510(k) summary for the Valeo™ Pedicle Screw System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding clinical studies, acceptance criteria for device performance (beyond substantial equivalence to predicate devices), or specific performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide information about:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results or effect sizes
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document primarily focuses on establishing substantial equivalence based on design, function, and materials to previously cleared devices. The "Performance Standards" section merely states "Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices," but it does not detail what that testing entailed or what the specific performance criteria or results were.

Ask a specific question about this device