(93 days)
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.