(29 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 Explorer TO 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 trays 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) summary for the SeaSpine Explorer TO System, an intervertebral body fusion device. It details the device's intended use and technological characteristics but does not describe acceptance criteria, a study that proves the device meets those criteria, or any performance metrics, expert involvement, or ground truth information relevant to an AI/ML device.
The document primarily focuses on establishing substantial equivalence to a predicate device (K193418) based on components, device description, intended use, technological characteristics, and mechanical safety. It states that "Mechanical and engineering analysis verified that the subject design changes do not introduce a new worse case nor raise any questions of safety or efficacy." This indicates that the evaluations were likely standard mechanical and engineering tests for an implantable medical device, rather than performance studies typically associated with AI/ML systems.
Therefore, I cannot provide the requested information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 conducted/described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not conducted/described.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable (this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (this is not an AI/ML 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.