(134 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 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 different sizes and footprints, to accommodate varying patient 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 F1295. 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. Additional cage sizes are the subject of this Special 510(k).
The provided document is a 510(k) premarket notification for a medical device called the "X-Pac Expandable Lumbar Cage System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or standalone algorithm performance) is not typically part of this kind of submission and is not present in the provided text.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it states that the device successfully underwent performance testing and met the requirements outlined by recognized standards.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Risk Assessment | New cage sizes do not introduce new issues of safety or effectiveness. | "A risk assessment... was conducted to confirm that the new cage sizes not introduce new issues of safety or effectiveness." |
| Verification & Validation Testing | Meet design specifications and intended function. | "The new cage sizes successfully underwent performance testing including verification and validation testing..." |
| Mechanical Testing | In accordance with ASTM F2077 for compression and compressive shear paradigms; ASTM F2267 for subsidence testing; and expulsion testing. | "The new cage sizes successfully underwent performance testing... and mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms; ASTM F2267 for subsidence testing; and expulsion testing. Test results demonstrate substantial equivalence to the predicate device." |
| Substantial Equivalence | The modified device is substantially equivalent to the predicate in terms of intended use, indications for use, overall design, function, technology, materials, and performance. | "The modified X-Pac Expandable Lumbar Cage System is identical to the predicate with respect to intended use, indications for use, overall design, function, technology, materials, and performance as well as procedural steps, surgical instrumentation, and product labeling." |
2. Sample size used for the test set and the data provenance
The document refers to mechanical testing of "new cage sizes." It does not specify a sample size (e.g., number of units tested) for these tests, nor does it refer to a "test set" in the context of patient data or clinical imaging. The testing is for the physical device, not an AI algorithm. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing relates to the mechanical properties of an implant, not to a diagnostic or interpretative task where expert ground truth would be established.
4. Adjudication method for the test set
This information is not applicable and not provided, as there is no "test set" requiring adjudication in the context of this device's mechanical evaluation.
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
No such study was done or reported. This type of study is relevant for AI-powered diagnostic or assistive devices, which the X-Pac Expandable Lumbar Cage System is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of this device would be defined by the specifications and expected performance defined by the relevant ASTM standards (ASTM F2077, ASTM F2267) and the predicate device's established performance. It's about meeting engineering and material science standards for an implant.
8. The sample size for the training set
This is not applicable and not provided. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this 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.