(161 days)
The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.
The Expanding Innovations X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this traditional 510(k).
This document describes a 510(k) premarket notification for the "X-Pac Expandable Lumbar Cage System" and states that the device is substantially equivalent to previously cleared predicate devices. The focus of this submission is on the addition of new cage sizes.
Based on the provided text, there is no information present regarding a study that proves the device meets specific acceptance criteria based on AI/ML performance. The document is a traditional 510(k) summary for a physical medical device (an intervertebral body fusion device) and discusses mechanical testing to confirm the safety and effectiveness of new cage sizes, not AI/ML performance.
Therefore, I cannot fulfill the request for information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not addressed in this filing.
The document focuses on:
- Device Type: Intervertebral body fusion device (physical implant).
- Purpose of Submission: Addition of new cage sizes to an existing cleared device.
- Performance Data: Mechanical testing (ASTM F2077, ASTM F2267, expulsion testing) to demonstrate substantial equivalence to predicate devices for the new sizes. This is not related to AI/ML performance.
- Ground Truth: For a physical device like this, "ground truth" would relate to mechanical properties, biocompatibility, and clinical outcomes, which are assessed through engineering tests and regulatory pathways (like 510(k) and post-market surveillance), not typically through expert consensus on image interpretation or pathology in the context of an AI/ML model.
If the request was based on the assumption that this document detailed an AI/ML device, that assumption is incorrect for this particular FDA filing.
§ 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.