(27 days)
When used as a vertebral body replacement:
When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.
When used as an intervertebral body fusion device:
When used as an intervertebral body fusion device, the Lucent Magnum device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent Magnum device.
Spinal Elements' Lucent Magnum device is a generally oval-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces.
The device body may be made from titanium alloy (Ti-6A1-4V) or polyetheretherketone (PEEK).
Devices are available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient.
The Lucent® Magnum device is a medical implant, and its acceptance criteria are based on mechanical performance demonstrating substantial equivalence to predicate devices, rather than a clinical study with human readers or AI.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | "Mechanical testing indicates that the Lucent Magnum device is capable of performing in accordance with its intended use." |
| Substantial Equivalence to Predicate Devices | "The Lucent Magnum device was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "study" referenced is mechanical testing, not a clinical trial with a test set of patient data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the assessment is based on mechanical testing and comparison to predicate devices, not expert human interpretation of medical data.
4. Adjudication method 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:
- No MRMC study was performed or is relevant to this device. This device is an implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the Lucent® Magnum's acceptance is based on established engineering principles and benchmarks for mechanical strength and durability of similar intervertebral body fusion devices, as demonstrated through mechanical testing. The comparison against legally marketed predicate devices serves as the standard for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.