(149 days)
Lucent intervertebral body fusion devices are 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 non-operative treatment prior to being treated with this device.
This product is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The devices may be manufactured from titanium (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3, polyetheretherketone materials conforming to ASTM F 2026 or polyetheretherketone with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance in relation to acceptance criteria, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or the ground truth establishment for a medical device.
The document is a 510(k) summary for a medical device called Lucent®, which is an intervertebral body fusion device. The purpose of this specific 510(k) is for a modification (larger sizes - line addition) to previously cleared devices. The document focuses on:
- Manufacturer and Contact Information
- Device Description: Describes the physical characteristics and materials of the Lucent device.
- Intended Use: Specifies the medical conditions, anatomical locations, and concomitant uses for the device.
- Performance Data: States that "Static torsion, ASTM F 2077" testing was performed. However, it does not provide the results of this testing or any acceptance criteria.
- Substantial Equivalence: Asserts that the device is substantially equivalent to predicate devices in stated aspects.
- FDA Correspondence: Official FDA letter granting clearance.
- Indications for Use (reiterated).
The document does not contain the kind of detailed study information you are asking for, which is typically found in full study reports or more comprehensive regulatory submissions.
§ 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.