(85 days)
X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
X-PAC® LLIF Expandable Lateral 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 the devices that are the subject of this 510(k) are placed via a lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.
Here's an analysis of the provided FDA 510(k) clearance letter and submission summary for the X-PAC® LLIF Expandable Lateral Cage System, focusing on acceptance criteria and supporting studies, presented in the requested format:
Important Note: The provided document is a 510(k) clearance letter and accompanying summary. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trials or extensive standalone performance studies in the way a PMA (Pre-Market Approval) might. Therefore, many of the requested details regarding human reader studies, expert qualifications for ground truth, and comprehensive clinical data are not typically found or required in a 510(k) for a device like an intervertebral cage system. The information below reflects what is available in the provided text.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (from pertinent standards) | Reported Device Performance |
|---|---|
| ASTM F2077-22 Standards: | Demonstrated equivalent or superior mechanical performance and fatigue compared to the predicate device. |
| - Static Axial Compression | Successfully underwent testing |
| - Dynamic Axial Compression | Successfully underwent testing |
| - Static Compression Shear | Successfully underwent testing |
| - Dynamic Compression Shear | Successfully underwent testing |
| - Expulsion & Subsidence Testing (ASTM 2267) | Successfully underwent testing |
| - Wear Analysis | Successfully underwent testing |
| Product Specifications | Meets product specifications |
| Product Labeling | Meets product labeling |
2. Sample Size used for the Test Set and the Data Provenance
The provided document describes non-clinical mechanical testing based on recognized standards. It does not refer to a "test set" in the context of patient data or algorithm performance.
- Sample Size for Test Set: Not applicable, as this was mechanical testing of the device, not a data-driven study on patient data.
- Data Provenance: Not applicable. The testing was conducted in a laboratory setting per ASTM standards.
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" for mechanical testing is established by adherence to the specified parameters and methodologies defined in the ASTM standards (e.g., force application, displacement measurement, wear rates). No human experts were involved in establishing "ground truth" for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. This was mechanical testing following standardized protocols, not a study requiring adjudication of expert interpretations.
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. An MRMC comparative effectiveness study is not mentioned or applicable to this device, which is an intervertebral cage system. This type of study is more common for diagnostic AI software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical medical implant, not an algorithm or AI software. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by the established parameters and methodologies of the ASTM F2077-22 and ASTM F2267 standards. These standards define acceptable performance limits for mechanical properties (e.g., strength, durability, resistance to wear and expulsion) for intervertebral body fusion devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth to establish for one.
§ 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.