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510(k) Data Aggregation
(29 days)
The VIPER systems are 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 of 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior 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® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Equivalence/Safety: The modified VIPER System components must perform mechanically as safely and effectively as the predicate device. | "Performance data in the form of an engineering rationale that included Finite Element Analysis was conducted to prove there was no new worst case component for the proposed VIPER System's components contained in this notification." "Both the engineering rationale that included Finite Element Analysis and the Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
| Material Equivalence: The materials used in the modified device must be identical to the predicate device and suitable for implant. | "Manufactured from ASTM F 138 implant grade stainless steel, ASTM F 139 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy." (Implicitly, these are the same as the predicate and acceptable.) |
| Design/Technology Equivalence: The design and technology of the modified components should be identical to the predicate systems, except for the specified changes. | "The proposed modifications to the DePuy Spine VIPER® Systems are identical to predicate devices (K111571) except for the addition of fully threaded and partially threaded favored angle polyaxial screws in various sizes to the systems, which are outside the range of the currently cleared screw offerings. The design, materials, and technology remain identical to the predicate systems." |
| Intended Use Equivalence: The modified device must have the same intended use and indications as the predicate device. | The "Indications For Use" statement is identical to the predicate device's intended use described in section H. The only change is the addition of new screw types within this existing intended use. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance data relied on Finite Element Analysis (FEA), which is a computational simulation method, not a test on physical samples in the traditional sense requiring a "test set" sample size or data provenance from a specific geographical region (country of origin). It's a predictive engineering analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. FEA uses engineering principles and material properties as its "ground truth" for simulation, not expert human interpretation of test data in the way a clinical study would. The analysis is performed by engineering professionals.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As FEA is a computational analysis, there is no "adjudication method" in the sense of reconciling human expert opinions on a test set. The results are derived directly from the simulation model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting medical images or data, which is not relevant to the engineering rationale and Finite Element Analysis performed for this device modification.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in essence, a "standalone" performance evaluation was done, though not a standalone algorithm in the typical AI sense. The Finite Element Analysis (FEA) is a computational method that stands alone in evaluating the mechanical performance based on engineering models, without human intervention in the execution of the mechanical test itself. The FEA itself is the "algorithm" that provides the performance data without a human-in-the-loop for the mechanical assessment.
7. The Type of Ground Truth Used
The ground truth used for the Finite Element Analysis (FEA) would be established engineering principles, material properties (e.g., strength, stiffness of ASTM F 138, F 139 stainless steel, and F 136 titanium alloy), and validated computational models (e.g., meshing, boundary conditions, load application matching physiological conditions). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of mechanical equivalence study.
8. The Sample Size for the Training Set
This information is not applicable/not provided. FEA is a simulation method, not a machine learning algorithm that requires a "training set." The models are built based on design specifications and material properties.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided. As there is no training set in the machine learning sense, there's no ground truth established for it. The "ground truth" for the FEA itself (as explained in point 7) is based on established scientific and engineering principles.
Ask a specific question about this device
(30 days)
The VIPER Systems are 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 Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VIPER Systems metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for 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 in skeletally mature patients.
The VIPER PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.
The VIPER Systems are 5.5mm rod systems offered in both titanium and stainless steel materials. The systems consist of monoaxial screws, polyaxial screws, uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy. The VIPER Systems 8mm to 12mm diameter favored angle polyaxial screws are not intended to be used with the VIPER PEEK rods.
The provided text outlines the 510(k) premarket notification for the DePuy Spine VIPER Systems, focusing on its substantial equivalence to predicate devices and performance data. It does not describe an AI medical device or a study involving acceptance criteria with sensitivity, specificity, or human reader performance. Instead, it describes a medical device (Pedicle Screw Spinal System) and its mechanical performance testing.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, sample sizes for test sets or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.
The document describes Performance Data for the VIPER Systems, which are mechanical tests rather than clinical or AI performance evaluations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance (ASTM F 1798) | The device must demonstrate mechanical properties (static and dynamic cantilever bending, axial pull-out, torsion, and static axial slip) that are substantially equivalent or superior to the identified predicate devices, ensuring it can withstand the expected mechanical loads in vivo without failure or compromise to its intended function. The specific quantitative criteria (e.g., stiffness thresholds, fatigue limits, pull-out force minimums) are not explicitly detailed in the summary but would be defined in the full test protocol. | The performance data submitted "characterize the subject VIPER Systems components." The Conclusion states: "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." This implies the tests met the established criteria for substantial equivalence to the predicate devices. |
| Biocompatibility | Biocompatibility requirements per ISO 10993 (or equivalent) for implantable devices. | While not explicitly detailed as "reported performance" in this summary, the use of "ASTM F 138 implant grade stainless steel, ASTM F 139 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy" for manufacturing indicates compliance with accepted biocompatibility standards for these materials. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. Mechanical testing typically involves a set number of samples per configuration (e.g., 5-10 samples per test condition) to satisfy statistical requirements for device qualification.
- Data provenance: The performance data was generated through "Performance data per ASTM F 1798" and submitted by DePuy Spine, Inc. This indicates laboratory testing of physical device components, not clinical data from patients or data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for mechanical testing is based on the physical properties and performance of the device components as measured by test equipment, not on expert interpretation of results in the way clinical diagnostic accuracy studies require.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, not for standard mechanical testing results.
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 document describes a medical device (spinal pedicle screw system) and its mechanical performance, not an AI medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for mechanical testing is based on objective, quantifiable measurements (e.g., load at failure, displacement, fatigue cycles) obtained from laboratory test equipment, adhering to ASTM F 1798 standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of performance evaluation.
8. The sample size for the training set:
- This is not applicable as the document describes a physical medical device and its mechanical testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- This is not applicable.
Ask a specific question about this device
(145 days)
The EXPEDIUM and VIPER Systems are 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 EXPEDIUM and 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; 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 subject EXPEDIUM and VIPER Spine System components consist of screws and are available in various geometries and sizes.
The provided document is a 510(k) Summary for the DePuy Spine EXPEDIUM® and VIPER® Systems, which are spinal fixation devices. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials and detailed acceptance criteria for an AI/algorithm.
Therefore, the specific information requested about acceptance criteria, study design for proving device performance against those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI/software-as-a-medical-device (SaMD) are not applicable to this submission.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for mechanical spinal implants, not an AI/software device. The "performance" is assessed through a comparison to predicate devices and mechanical testing, not against specific diagnostic or treatment accuracy acceptance criteria as would be expected for a SaMD.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of an AI/software device. The performance was evaluated via non-clinical mechanical testing of the physical implants. The document does not specify the number of units tested, but mechanical tests typically involve a pre-determined number of samples to ensure statistical validity for the specific test (e.g., fatigue or static load).
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, in the context of AI/SaMD, refers to the verified correct output (e.g., diagnosis, measurement) for comparison with the algorithm's output. For mechanical implants, "ground truth" is typically defined by engineering specifications and material properties, verified through testing procedures against established standards (e.g., ASTM F1798). Experts involved would be engineers and material scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions when establishing ground truth for AI/SaMD. This is not pertinent to the mechanical testing of spinal implants.
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
- Not Applicable. MRMC studies are designed to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists, pathologists). This device is a physical implant, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This concept applies to AI algorithms and not to physical medical devices like spinal implants.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical testing: The "ground truth" (or reference standard) for the nonclinical tests would be the established scientific and engineering principles outlined in the cited ASTM standards (F1798). Performance is measured against physical properties and failure points defined by these standards, not against biological or clinical outcomes or expert consensus on images.
8. The sample size for the training set
- Not Applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. Since there is no training set, this question is not relevant.
Summary of what the document does provide regarding device performance:
The document states that "No clinical tests were performed."
Instead, the device's performance and safety were established through "Nonclinical Test Summary:"
- Static Cantilever Beam in accordance with ASTM F1798
- Dynamic Cantilever Beam in accordance with ASTM F1798
- Axial Slip in accordance with ASTM F1798
These tests are designed to evaluate the mechanical properties and stability of the spinal implants and their interconnection mechanisms, ensuring they meet the requirements for their intended use and are comparable to predicate devices. The "acceptance criteria" here are implied to be the successful completion of these tests in accordance with the ASTM standards, demonstrating structural integrity and mechanical equivalence to the already cleared predicate devices. The specific results of these tests (e.g., actual load values, cycles to failure) are not detailed in this 510(k) summary but would have been submitted to the FDA in a more comprehensive report.
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