(95 days)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
The SeaSpine Skipjack System is an intervertebral fusion device with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from Titanium Alloy per ASTM F136 and consist of two different options: an adjustable, expanding spacer and an adjustable, lordotic angle option. All implants and instruments are provided non-sterile in system-specific travs and are to be sterilized by the end user. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary.
The provided document is a 510(k) Premarket Notification for the SeaSpine Skipjack System, an intervertebral body fusion device. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance through clinical studies. Therefore, the document explicitly states:
"Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
Based on this statement, it is impossible to provide information regarding device performance, acceptance criteria, or the details of a study proving the device meets these criteria as requested in your prompt.
The document is for a medical device (an intervertebral body fusion device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) product. Your request for information regarding AI-specific criteria such as MRMC studies, standalone algorithm performance, training/test set sample sizes, and ground truth establishment is not applicable to the device described in this 510(k) submission.
Therefore, I cannot fulfill your request with the information provided in the input text.
§ 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.