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510(k) Data Aggregation
(101 days)
Segmental Plating System (SPS)
The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
IdentiTi SPS Interbody System
The IdentiTi SPS Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
IdentiTi NanoTec SPS Interbody System
The IdentiTi SPS Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
Transcend SPS Interbody System
The Transcend SPS Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/ or pain at multiple contiguous levels from C2-T1. The Transcend SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
Transcend NanoTec SPS Interbody System
The Transcend SPS PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs. CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.
The Segmental Plating System (SPS) is intended for anterior fixation to the cervical spine. The Segmental Plating System (SPS) consists of a variety of sizes of 2 - 4 holes plates and 3.5 mm and 4.0 mm screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The plate includes a screw anti-backout mechanism. The system will offer instrumentation for the delivery of the plate and screw construct. The instruments in this system are intended for use in surgical procedures. The plate system implants are provided non-sterile to be steam sterilized by the end user.
The IdentiTi and Transcend SPS Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through anterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, commercially pure titanium (CP Ti Grade 2) per ASTM F67, and an optional hydroxyapatite nano (HAMM) surface treatment. The subject system implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. The subject IdentiTi and Transcend NanoTec SPS Interbody Systems interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents a nano-scale topography on the entirety of the implant surface. in addition to macro-/micro-scale topography existing from prior to HA man treatment. The interbody spacers are provided individually packaged and sterile.
The provided text is a 510(k) summary for a medical device (Alphatec Spine Inc.'s Segmental Plating System and Interbody Systems). It discusses regulatory clearance based on substantial equivalence to predicate devices, outlines the device's description, indications for use, and a technological comparison. It also lists performance data from non-clinical testing.
However, the provided text does not contain information about acceptance criteria for an AI/ML medical device, nor does it describe a study involving a test set, ground truth determination, expert consensus, or human-in-the-loop performance evaluation. The document primarily focuses on the mechanical and material aspects of spinal implants and their equivalence to existing devices, with performance data relating to mechanical testing standards (e.g., ASTM F2077, F2267, F1717).
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present. The device in question is a physical implant, not an AI/ML-based diagnostic or therapeutic device.
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(77 days)
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend VBR System is also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.
The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend NanoTec VBR System is also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.
The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.
The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.
The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
This document is a 510(k) premarket notification for a medical device – the Ascend™ VBR System and Ascend™ NanoTec™ VBR System, which are vertebral body replacement devices. The content focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for FDA clearance.
The provided text does not contain any information about an AI/ML-based device or its performance criteria. The entire document pertains to physical medical devices (spinal implants) and their mechanical, chemical, and biological performance characteristics.
Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document details traditional medical device testing, such as:
- Static and Dynamic Axial Compression per ASTM F2077
- Static and Dynamic Torsion per ASTM F2077
- Static Subsidence per ASTM F2267
- Static Push-out
- Gravimetric Analysis per ASTM F1714
- Particulate Analysis per ASTM F1877
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
- Biocompatibility Testing per ISO 10993-1
These tests are standard for evaluating the mechanical and biocompatibility properties of physical implants, not the performance of an AI/ML algorithm.
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