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The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization 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 Spine 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.

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); trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior noncervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatic pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The purpose of this premarket notification is to obtain market clearance of packaged sterile VIPER PRIME Screws. VIPER PRIME Screws with Fenestrations and EXPEDIUM Verse Screws with Fenestrations. These devices are to be provided sterile via gamma radiation.

The VIPER PRIME Screws are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME Screws are intended for use with existing components of the VIPER system to generate a posterior construct to provide immobilization and stabilization of spinal segments as an adjunct to fusion.

The VIPER PRIME Screws with Fenestrations and the EXPEDIUM Verse Screws with Fenestrations are intended for use with existing components of the VIPER and EXPEDIUM Verse system to generate a posterior construct to provide immobilization and stabilization of spinal segments. The VIPER PRIME Screws with Fenestration and the EXPEDIUM Verse Screws with Fenestrations are designed with a cannulation through the screw shank and fenestrations and may be used in conjunction with, or without, CONFIDENCE High Viscosity Spinal Cement in accordance with the indications for use specified below.

The provided document is a 510(k) summary for medical devices (pedicle screws) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML performance.

The document primarily focuses on establishing "substantial equivalence" of new versions of pedicle screws (VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations) to previously cleared predicate devices. The key change highlighted is that the subject devices will be terminally sterilized via gamma radiation, while the design, materials, indications, and technology remain identical to the predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text. There are no acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance mentioned in the document. This type of submission is for mechanical devices and not for AI/ML-driven diagnostics or assistive tools.

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The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization 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 Spine 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); 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior noncervical pedicle screw fixation in pediatic patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VIPER System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The system is composed of components offered in a range of sizes to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors including screws, longitudinal members including rods and interconnection mechanisms including set screws. The system is compatible with transverse connectors, like the SFX cross connector from the EXPEDIUM Spine System. The system components are implanted using class I premarket notification exempt manual surgical instruments.

The purpose of this premarket notification is to add additional sizes (lengths and diameters) of VIPER PRIME screws with fenestrations. The VIPER PRIME screws with fenestrations are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME screws with fenestrations are intended for use with existing components of the VIPER System to generate a posterior construct to provide immobilization and stabilization of spinal segments. The VIPER PRIME screws with fenestrations are designed with a cannulation through the screw shank and lateral fenestrations and may be used in conjunction with, or without, CONFIDENCE™ High Viscosity Spinal Cement in accordance with the indications for use specified below.

The provided document is a 510(k) premarket notification for a medical device called "Additional VIPER PRIME™ screws with fenestrations." This document primarily focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, rather than presenting a study proving a device meets acceptance criteria for an AI/ML powered device.

Therefore, the information required to answer your prompt about acceptance criteria and a study proving device performance (especially in the context of AI/ML or diagnostic performance) is not present in this document. The document details the device's indications for use, technological characteristics, and performance data related to its mechanical properties (e.g., dynamic compression testing, foam block testing, cement flow testing, and engineering analysis), which are standard for orthopedic implants, not AI/ML systems.

To illustrate, here's an explanation of why the requested information cannot be found:

• No AI/ML, Diagnostic, or Image Analysis Component: The device is a pedicle screw system, a physical implant used in spinal surgery. There is no mention of any software, AI, imaging, or diagnostic functionality.
• Performance Data Type: The "Performance Data" section (Section I on page 6) refers to mechanical testing (e.g., ASTM F1717 for dynamic compression testing, foam block testing, cement flow testing, and engineering analysis). This type of data confirms the physical and mechanical properties of the screw, not its diagnostic accuracy or an AI's performance.
• Purpose of 510(k): A 510(k) submission aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics (materials, design, performance principles), and safety/effectiveness. It does not generally involve efficacy trials or performance studies against specific acceptance criteria for AI or diagnostic accuracy.

In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria for an AI/ML device, patient-level study design, expert ground truth establishment, or human reader performance with/without AI assistance.

Ask a specific question about this device

The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization 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 Spine 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.

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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER Spine System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER Spine Systems are intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VIPER System (including VIPER2) is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The system is composed of components offered in a range of sizes to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors including screws, longitudinal members including rods and interconnection mechanisms including set screws. The system is compatible with transverse connectors, like the SFX cross connector from the EXPEDIUM Spine System. The system components are implanted using class I premarket notification exempt manual surgical instruments.

The purpose of this premarket notification is to add new screws. The VIPER PRIME screws with fenestrations are designed to facilitate a posterior percutaneous approach with minimally invasive surgery (MIS) instrumentation. The VIPER PRIME screws with fenestrations are intended for use with existing components of the VIPER System to generate a posterior construct to provide immobilization and stabilization of spinal segments. The VIPER PRIME screws with fenestrations are designed with a cannulation through the screw shank and lateral fenestrations and may be used in conjunction with, or without, CONFIDENCE™ High Viscosity Spinal Cement in accordance with the indications for use specified below.

This document is a 510(k) premarket notification for a medical device (VIPER PRIME™ Screws with Fenestrations), not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study performance, sample sizes, expert involvement, ground truth methods, or MRMC studies.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: Listing the intended clinical applications (e.g., spinal instability, trauma, tumors).
• Device Description: Detailing the components and their function.
• Technological Characteristics: Material (Titanium alloy), design (cannulated, fenestrated screws), and performance testing (mechanical testing, computational study, engineering analysis).

In summary, this document does not provide the information needed to answer your questions about acceptance criteria and study proving device performance for an AI/ML medical device.

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