(149 days)
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1), and must be used with bone screw fixation and locking covers.
When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).
The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™C Interbody System offers spacers in low profile (TruProfile) and no profile versions and are manufactured from Ti-6Al-4V titanium alloy per ASTM F3001.
The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) summary for the SeaSpine WaveForm™ C Interbody System, a medical device used in spinal fusion procedures. This document describes the device, its intended use, and its equivalence to legally marketed predicate devices.
However, the document does not contain any information regarding clinical studies, acceptance criteria for an AI/ML-based medical device, or performance metrics typically associated with such systems. Specifically, it lacks details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or retrospective/prospective study designs.
- The number or qualifications of experts establishing ground truth.
- Adjudication methods for test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone AI algorithm performance.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Training set sample sizes or ground truth establishment for a training set.
The document focuses on the mechanical and biological performance of the interbody system as a physical implant, not on its performance as an AI/ML-driven diagnostic or prognostic tool. The non-clinical testing mentioned (ASTM F2077, F2267, and F1877) refers to standards for intervertebral body fusion devices, which typically cover mechanical properties, material biocompatibility, and sterilization, not AI algorithm performance.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves an AI/ML device meets those criteria, as no such information is present.
§ 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.