(126 days)
The SpineView 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 Spine View X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and 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 to accommodate varying anatomy. The primary difference between the previously cleared and the modified cage models is that the expansion of the upper plate is parallel to the bottom housing, whereas the previously cleared device expands at an angle. 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 Spine View 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 instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before use.
The provided text is a 510(k) premarket notification for the SpineView X-Pac Expandable Lumbar Cage System. It details the device's description, indications for use, and a comparison to a predicate device, focusing on mechanical testing performance data to demonstrate substantial equivalence.
However, the document does not contain any information about a study proving the device meets acceptance criteria related to an AI/machine learning model's performance, human reader studies (MRMC), or a standalone algorithm performance. The acceptance criteria discussed in the document are limited to the mechanical performance of the physical device (e.g., static and dynamic compression, subsidence, expulsion) in accordance with FDA guidance and ASTM standards for intervertebral fusion devices.
Therefore, I cannot provide the requested information regarding AI model performance, expert ground truth, adjudication methods, or MRMC studies because this document pertains to a physical medical device and not a software as a medical device (SaMD) or an AI-enabled diagnostic tool.
The information I can extract, pertaining to the physical device's acceptance criteria and performance, is as follows:
1. Table of Acceptance Criteria (Mechanical Performance) and Reported Device Performance:
| Acceptance Criteria (Mechanical Performance) | Performance Metric Mentioned | Reported Device Performance (Implied "Meets" or "Demonstrates SE") |
|---|---|---|
| Static Compression | Mechanical Testing | Conducted to demonstrate substantial equivalence to predicate. |
| Dynamic Compression | Mechanical Testing | Conducted to demonstrate substantial equivalence to predicate. |
| Static Compression-Shear | Mechanical Testing | Conducted to demonstrate substantial equivalence to predicate. |
| Dynamic Compression-Shear | Mechanical Testing | Conducted to demonstrate substantial equivalence to predicate. |
| Subsidence | Mechanical Testing | Conducted to demonstrate substantial equivalence to predicate. |
| Expulsion | Mechanical Testing | Conducted. |
Note: The document states that these tests were conducted "to demonstrate substantial equivalence to the predicate," implying that the performance met the thresholds necessary for this claim. Specific numerical performance values are not provided in this summary.
Regarding the other requested information (2-9), it is not applicable to this document as it does not describe an AI/ML-based device or a clinical study for software performance:
- 2. Sample size used for the test set and the data provenance: Not applicable to this type of device (physical implant). Mechanical testing utilizes test samples of the device itself, not patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is for a physical implant, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the performance requirements of the ASTM standards and FDA guidance for intervertebral fusion devices (e.g., specific load capacities, displacement limits).
- 8. The sample size for the training set: Not applicable. There is no AI model or training set described.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a physical medical device (SpineView X-Pac Expandable Lumbar Cage System) through mechanical performance testing, rather than the performance of an AI/machine learning algorithm.
§ 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.