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The VIPER Spine 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 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 posterior percutaneous 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. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.

The EXPEDIUM Spine 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 EXPEDIUM™ 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; pseudarthrosis; and failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.

This submission addresses additional rod components. Rod components are manufactured from medical grade PEEK (polyetheretherketone) polymer both with and without 6% barium sulfate (BaSO4) filler and ASTM F 560 implant grade tantalum wire. Setscrew components are manufactured from ASTM F 136 implant grade titanium alloy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VIPER™ and EXPEDIUM™ Spine Systems:

Acceptance Criteria and Device Performance

Study Information

Based on the provided text, the submission is a "Traditional 510(k) Submission" for additional rod components for existing spine systems. The regulatory review focuses on substantial equivalence to predicate devices. This type of submission typically relies heavily on performance data from recognized standards rather than extensive clinical studies with human participants.

Here's a breakdown of the study-related information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of human data. The performance data provided is for material and mechanical testing using ASTM standards. The sample sizes for these specific tests (e.g., number of rods tested, number of cycles) are not detailed in the provided summary.
   • Data Provenance: Not applicable in the context of human data. The performance data is derived from in-vitro mechanical testing according to established ASTM standards. The country of origin for such laboratory testing is not specified but is typically performed by the manufacturer or a certified testing lab. It is a retrospective analysis of device performance against standards.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. The "ground truth" for this device, in terms of its substantial equivalence, is based on its compliance with established mechanical standards (ASTM F 1717 and ASTM F 1798) and material specifications. There is no explicit mention of human experts establishing "ground truth" for a test set in the way one would for diagnostic imaging.
   • The "experts" involved are the engineers and material scientists who designed and tested the device, and the regulatory bodies (like FDA) who evaluate compliance with standards.

3. Adjudication Method for the Test Set:

   • Not applicable. This device relies on objective, quantifiable mechanical and material testing against established standards, not subjective interpretations requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. The provided documentation does not indicate that a MRMC comparative effectiveness study was done. This type of study is more common for diagnostic devices where human interpretation of data (e.g., medical images) is central. For an orthopedic implant like a spinal rod, the focus is on mechanical integrity and material properties.
   • Effect Size: Not applicable, as no such study was conducted.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, in spirit. The performance data submitted is for the device itself (the rods and setscrews) independent of human-in-the-loop performance. Its mechanical properties and material composition are characterized in a "standalone" fashion against engineering standards.
   • However, this is not an "algorithm" in the typical sense of AI/software performance. It's the physical device's performance.

6. Type of Ground Truth Used:

   • Engineering Standards and Material Specifications: The "ground truth" for the device's performance is compliance with established ASTM (American Society for Testing and Materials) standards: ASTM F 1717 ("Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model") and ASTM F 1798 ("Standard Guide for Evaluation of Spinal Intervertebral Body Fusion Devices in vitro"). Additionally, material "ground truth" is based on medical-grade PEEK and titanium alloys meeting specific ASTM F 560 and ASTM F 136 standards.

7. Sample Size for the Training Set:

   • Not applicable. This submission concerns a physical implant, not a machine learning algorithm that requires a "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for a machine learning model.

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The VIPER Spine 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 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 posterior percutaneous 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.

This submission addresses additional rod components.

The provided document does not contain information regarding software or AI. It describes additions to a spinal implant system called VIPER™ Spine System. Therefore, I cannot extract information related to acceptance criteria, device performance, studies, sample sizes, ground truth, or expert involvement as these are not relevant to the content of this document.

The document discusses the regulatory approval (510(k) submission) of additional rod components for the VIPER™ Spine System, a medical device for spinal fixation. It details the device's intended use and materials, and mentions that "Performance data were submitted to characterize the subject VIPER™ Spine System components addressed in this notification." However, it does not provide the actual acceptance criteria, the results of the performance data, or details of any specific studies (e.g., sample sizes, ground truth establishment, expert involvement, or MRMC studies).

The FDA's letter states that they have reviewed the submission and find the device substantially equivalent to legally marketed predicate devices, allowing its marketing. This regulatory approval is based on the provided performance data, but the specifics of that data are not included in this extract.

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