(17 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 surqical 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 Special 510(k).
This document describes the X-Pac Expandable Lumbar Cage System, an intervertebral body fusion device. The focus of the provided text is on demonstrating substantial equivalence to previously cleared devices rather than a de novo clinical study with specific acceptance criteria for performance.
Therefore, the information regarding acceptance criteria and performance is primarily concerned with mechanical testing to show the continued safety and effectiveness of new cage sizes, rather than a clinical study evaluating diagnostic accuracy or efficacy against specific clinical endpoints.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms. | New cage sizes successfully underwent performance testing. Test results demonstrate substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated; however, "new cage sizes" implies a set of different configurations were tested.
- Data provenance: Not explicitly stated, but the testing was conducted in-house by Expanding Innovations, Inc. (or a contracted lab) as part of their risk assessment. This is not patient data but rather engineering test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on engineering standards (ASTM F2077) and the performance of a predicate device, not on expert clinical interpretation of patient data.
4. Adjudication method for the test set:
- Not applicable. This was mechanical testing against a standard, not a clinical trial requiring adjudication of patient outcomes or expert consensus.
5. 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. This device is a surgical implant (lumbar cage), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (implant), not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the mechanical testing was defined by the performance requirements of ASTM F2077 and comparison to a legally marketed predicate device (K152539, K160856, K201145, and K203802). The goal was to show that the new sizes of the device performed equivalently to the predicate and met the established mechanical standards.
8. The sample size for the training set:
- Not applicable. This refers to mechanical testing of physical device variations, not a machine learning model with a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is mechanical testing, not a machine learning study.
Summary from the document:
The core of this 510(k) submission is to demonstrate substantial equivalence of new cage sizes for the X-Pac Expandable Lumbar Cage System to previously cleared versions (predicates). The primary evidence provided is a risk assessment, including mechanical testing, which confirmed that the new cage sizes do not introduce new issues of safety or effectiveness. This testing was performed in accordance with ASTM F2077 for compression and compressive shear. The results indicated that the new device sizes performed equivalently to the predicate devices. There is no mention of a human-in-the-loop study, a multi-reader multi-case study, or an AI algorithm’s performance.
§ 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.