(59 days)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone. The SeaSpine WaveForm A Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
No-profile Implants w/ Screws:
The SeaSpine WaveForm A System No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
No-profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, 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 spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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 WaveForm A Noprofile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A System Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant 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 spacer component may be packed with autogenous bone graft composed of cancellous, cortical, 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. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.
The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic configurations to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The WaveForm A Interbody can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile Interbody configurations. Fixation implants include Anterior Plates, Spin Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
This document describes the FDA's 510(k) clearance for the SeaSpine WaveForm A Interbody System. In this case, the clearance is based on substantial equivalence to predicate devices, meaning extensive clinical studies or specific acceptance criteria for device performance as a standalone AI system are not provided in this document.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the device is cleared based on demonstrating substantial equivalence to legally marketed predicate devices, not on meeting specific quantitative performance metrics against a defined acceptance criterion for a novel AI function. The "acceptance criteria" here are implicitly that the device performs as well as or similarly to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in: | The WaveForm A Interbody System is "identical or similar to the cited predicate systems in regard to intended use/indications for use, device description, technological characteristics (e.g., operating principle, design, components, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing)." |
| Mechanical performance to predicate systems | Demonstrated "substantially equivalent mechanical performance to the predicate systems through axial compression-shear (ASTM F2077), wear evaluation (ASTM F1877), and subsidence (ASTM F2267) testing." |
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/software device that undergoes testing with a "test set" of patient data. The evaluation is for a physical intervertebral body fusion device and is based on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an implantable medical device, not an AI software intended to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's clearance is that its design, materials, and mechanical performance are substantially equivalent to legally marketed predicate devices, as demonstrated through non-clinical mechanical testing.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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.