Search Results
Found 2 results
510(k) Data Aggregation
(30 days)
The VIPER System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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 in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The VIPER® Systems consist of rods and cannulated screws used in a percutaneous approach and are available in various geometries and sizes. The proposed Viper® 4.35mm diameter cannulated screws maintain the identical cannulation through the center of the screw shank as the previously cleared Viper® pedicle screws. The screw shank component of the proposed screws will have the same dual lead thread form, tapered distal tip, and same flutes as the previously cleared Viper® screws and are available in polyaxial or uniplanar configurations.
This is a 510(k) summary for a medical device, the Viper™ Spinal System, which falls under the category of spinal implants. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on a device's performance against set acceptance criteria in the context of AI or diagnostic accuracy.
Therefore, many of the requested categories regarding acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, sample sizes for training/test sets, and expert qualifications) are not applicable to this type of regulatory submission. This document describes a traditional medical device (spinal system components), not an AI/ML-driven diagnostic or assistive device.
Here's an analysis of the provided text, addressing the closest relevant information and explicitly stating when a category is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Specifications: Manufactured from implant grade stainless steel (ASTM F 138) and titanium alloy (ASTM F 136). | Material Conformance: "Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy." |
| Mechanical Performance: Meet static and fatigue requirements relevant to spinal fixation systems (e.g., per ASTM F 1717). | Mechanical Performance: "Performance data per ASTM F 1717 were submitted to characterize the subject VIPER System components... This testing was compromised of static and fatigue testing on the proposed device. Specifically, static and dynamic compression testing as well as static torsion and cantilever beam testing were performed." |
| Design Equivalence: Maintain identical design principles (cannulation, thread form, tip, flutes) to previously cleared Viper® pedicle screws. | Design Equivalence: "The proposed Viper® 4.35mm diameter cannulated screws maintain the identical cannulation through the center of the screw shank as the previously cleared Viper® pedicle screws. The screw shank component of the proposed screws will have the same dual lead thread form, tapered distal tip, and same flutes as the previously cleared Viper® screws." "The design, materials, and technology remain identical to the predicate system." |
| Intended Use Equivalence: Similar indications for use as predicate devices. | Intended Use Equivalence: The stated "Intended Use" (Section F) is consistent with the predicate devices and the device seeks to demonstrate substantial equivalence based on this. |
| Safety and Effectiveness: Demonstrate device is as safe, as effective, and performs as well as the predicate device. | Conclusion: "Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the summary. For mechanical testing, "sample size" typically refers to the number of test articles (screws, rods) subjected to various loads. The document states "Performance data per ASTM F 1717 were submitted," which is a standard for spinal implant testing, but it does not specify the number of samples tested or the exact conditions of data provenance beyond being submitted for regulatory review. This is not a clinical study involving patient data.
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 is not applicable. This submission is for a physical medical device (spinal implant), not a diagnostic device requiring expert interpretation or ground truth establishment based on clinical data. The "ground truth" for this device's performance is derived from standardized mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods are typically used in clinical studies, especially for evaluating diagnostic outputs. This submission is for a physical medical device.
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
- This is not applicable. This is not an AI-driven device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be conducted or relevant for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For this type of device, the "ground truth" for performance is established through objective, standardized mechanical testing (e.g., tensile strength, fatigue life, torsional resistance) as defined by standards like ASTM F 1717. This is not clinical ground truth derived from patient observations or expert consensus.
8. The sample size for the training set
- This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable. As it's not an AI/ML device, there is no training set or associated ground truth to establish in that context.
Ask a specific question about this device
(21 days)
The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The VIPER Spine System consists of cannulated polyaxial pedicle screws and 5.5mm rods in various lengths. The VIPER Spine System also contains Class 1 manual surgical instruments to aid in the percutaneous approach, and cases that are considered exempt from premarket notification. Manufactured from ASTM F-136 implant grade titanium alloy.
The provided text is for a 510(k) premarket notification for a medical device called the VIPER™ Spine System. This is a mechanical device (spinal fixation system), not an AI/Software as a Medical Device (SaMD).
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details, which are typically relevant for AI/SaMD, is not applicable to this document.
The "Performance Data" section in the K061520 submission simply states: "Performance data were submitted to characterize the cannulated polyaxial screws." This indicates that some form of engineering or mechanical testing was conducted to ensure the device's physical properties and functionality met relevant standards (e.g., strength, fatigue, biocompatibility), but the specific criteria and results are not detailed in this summary.
In summary, none of the requested information regarding AI/SaMD performance criteria and study details can be extracted from this document because it describes a hardware medical device lacking an AI component.
Ask a specific question about this device
Page 1 of 1