(143 days)
When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with the bone screws, the SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
When used with the SpinPlate, the Vu a•POD Prime Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. When used with the SpinPlate, the Vu a POD Prime Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD Prime Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand-alone device. If the Vu a•POD Prime Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine Vu aºPOD Prime Intervertebral Body Fusion Devices are anterior intervertebral body fusion devices (IBD) which can be used in combination with two Bone Screws, a SpinPlate, or both Bone Screws and SpinPlate together. When used with Bone Screws or Bone Screws and SpinPlate, the system is a stand-alone device. When used with the SpinPlate alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). The Bone Screws and SpinPlate are manufactured from Ti-6A1-4V ELI per ASTM F136.
The Vu a•POD Prime IBD spacers are comprised of PEEK-OPTIMA LT1 polymer and include large central graft windows, which are packed with bone graft prior to implantation. The spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM). Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation.
The Vu aºPOD Prime IBD NanoMetalene implants are provided in gamma sterilized packaging; the Vu a•POD Prime IBD PEEK spacer, Bone Screws, and SpinPlate are provided non-sterile for subsequent sterilization at the healthcare facility. The instruments included with the Vu a•POD Prime IBD facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device" and "SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device".
This document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance data related to AI/algorithm performance.
Instead, it's a submission to demonstrate substantial equivalence to legally marketed predicate devices. The section explicitly states:
- Clinical Testing: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
- Non-Clinical Testing: Mentions that previous analyses verified "no new worst cases were created for Static Axial and Shear Compression, Dynamic Axial and Shear Compression per ASTM F2077, and Subsidence per ASTM F2267," and "the subject devices have equivalent mechanical strength to the predicates." It also refers to packaging, shipping, sterility, and bacterial endotoxin testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and AI/algorithm study results based on this document. The device in question is an intervertebral body fusion device, which is a physical implant, not an AI-driven diagnostic or assistive tool.
To answer your request, a document detailing the clinical trials or performance studies for an AI/algorithm-driven medical device would be necessary.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.