(26 days)
When used as a vertebral body replacement:
When used as a vertebral body replacement, the Lucent 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 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 device.
Spinal Elements' Lucent device is a generally box-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.
This document is a 510(k) summary for the Lucent® spinal device, a medical implant. The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through clinical studies in the same way a PMA (Premarket Approval) would.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study demonstrating device performance against those criteria in the context of an AI/algorithm-driven device.
Specifically:
- Table of acceptance criteria and reported device performance: Not present. The document focuses on comparing the Lucent® device to existing predicate devices based on design, materials, function, and indications for use.
- Sample size used for the test set and data provenance: No test set is mentioned as this is not a study proving new performance.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This document describes a physical medical implant, not an AI or imaging diagnostic device.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Explanation Based on the Document:
The document states: "The Lucent devices of this submission are identical to predicates in indications for use, general design, function, and materials. Dimensional measurements are the only difference between predicates and the devices of this submission."
This means that the basis for acceptance is substantial equivalence to already cleared devices (Lucent® K071724 and Lucent® Magnum K073348), rather than a new study establishing performance against specific, novel acceptance criteria for the new device. The FDA's review in a 510(k) context primarily assesses whether the new device is as safe and effective as a legally marketed device, often without requiring new clinical performance data if substantial equivalence can be demonstrated through technological characteristics and intended use.
§ 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.