(374 days)
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.
The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136. The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.
This document describes the FDA's 510(k) clearance for the Spectrum Spine Expandable Titanium PLIF/TLIF System, an interbody fusion device. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, primarily through mechanical performance testing, rather than an AI/ML-based device requiring a study proving its performance against acceptance criteria for diagnostic or prognostic tasks.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets these in the context of AI/ML performance (e.g., sensitivity, specificity, reader improvement, ground truth establishment) is not applicable to this submission.
The document primarily provides the following:
1. A table of acceptance criteria and the reported device performance:
This is described in terms of mechanical testing for intervertebral fusion devices, not diagnostic performance.
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Acceptance Criteria (Testing Modes):
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
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Reported Device Performance:
"The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
(Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence based on these tests is stated.)
The remaining points (2-9) are not relevant as this is not an AI/ML device that requires a diagnostic or prognostic performance study:
- Sample size used for the test set and the data provenance: Not applicable to a mechanical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is based on engineering standards and performance in stress tests, not expert interpretation of medical images or data.
- Adjudication method 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. This is a physical implant, not a diagnostic AI tool.
- 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.): The "ground truth" for this device's performance is its ability to withstand mechanical forces according to established ASTM standards, indicating its structural integrity and safety for its intended use, as compared to predicate devices.
- The sample size for the training set: Not applicable. No AI model involved.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter for a Class II medical device (surgical implant) based on substantial equivalence through mechanical testing, not an AI/ML device requiring clinical performance evaluation against specific diagnostic or prognostic metrics.
§ 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.