(28 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 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. 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 non-sterile, and are intended to be cleaned and steam sterilized before each use.
I am sorry, but the provided text from the FDA 510(k) K222797 submission for the "X-Pac Expandable Lumbar Cage System" does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or diagnostic algorithm.
The document is a traditional 510(k) for a medical device (an intervertebral body fusion device) that focuses on substantial equivalence to predicate devices based on design, materials, indications for use, and performance within the context of mechanical and biological functionality, not algorithmic performance or diagnostic accuracy.
Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for an AI or diagnostic algorithm's performance.
- Sample sizes used for the test set and the data provenance: Not applicable as there's no AI/diagnostic study described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The "Performance Data" section (Page 5, H. Technological Comparison, I. Performance Data) states:
"A risk assessment was conducted to confirm that the modification to the Indications for Use Statement does not introduce new issues of safety or effectiveness."
This refers to a standard risk assessment for mechanical devices, not data-driven performance metrics for an AI/diagnostic system.
In summary, the provided document relates to a physical implantable medical device, not a software device or AI-powered diagnostic tool, and therefore does not contain the information you are requesting about acceptance criteria and performance studies for an algorithmic 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.