(308 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, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
The Lucent® device 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.
This document is a 510(k) summary for a medical device called Lucent®, an intervertebral body fusion device.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide acceptance criteria or reported device performance in the typical sense of quantitative metrics for a study. This 510(k) pertains to line additions to an already cleared device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria.
The "Performance Data" section explicitly states: "No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed."
Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
As stated above, no new performance data or clinical testing was conducted for this 510(k) submission. The device's substantial equivalence is based on its similarity to previously cleared devices. Therefore, there is no test set sample size or data provenance to report from this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Since no new performance data or clinical testing was performed, there was no test set for which ground truth needed to be established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no test set was used for new performance evaluation.
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 device is an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no new performance validation using a specific ground truth was conducted. The ground for substantial equivalence relies on comparison of design, materials, and indications for use with predicate devices.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Summary of Device Acceptance and Study proving criteria:
The document describes the device, Lucent®, as an intervertebral body fusion device. This 510(k) submission is for line additions to an already cleared device. The primary method of demonstrating acceptance and meeting criteria is through substantial equivalence to legally marketed predicate devices.
The study that "proves" the device meets acceptance criteria, in this context, is the comparison to predicate devices. The submission argues that:
- The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.
- It has equivalent technological characteristics to its predicates in areas including labeling/indications for use, general design features, function, material, manufacturing process, and instrumentation.
Therefore, the "proof" is based on the argument that because the device is sufficiently similar to devices already found safe and effective, no new performance studies are required.
§ 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.