Search Results

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).

These devices are 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 subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as an interbody device or interbody cage. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. The exterior of the devices have "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are surgically positioned.

The devices submitted herein may be manufactured from polyetheretherketone (PEEK) materials and titanium alloy (Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472) or PEEK material conforming to ASTM F 2026 with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces and titanium alloy (Ti-6Al-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472). Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are placed in various locations of the PEEK devices to serve as markers for radiographic visualization of device orientation.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called Lucent® XP Curved, an intervertebral body fusion device.

Based on the provided text, the device does not involve an AI/ML component or complex diagnostic performance. Therefore, a study demonstrating the device meets acceptance criteria related to AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop improvement, ground truth methodology) is NOT applicable here.

The acceptance criteria and supporting "study" are primarily focused on mechanical performance and material characteristics to demonstrate substantial equivalence to a previously cleared predicate device.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document states: "All data indicates that the device will perform as intended." The "acceptance criteria" are implied by adherence to the referenced ASTM standards and the demonstration of "substantial equivalence" to the predicate. No numerical performance metrics are provided in a table format in this document, as the focus is on similarity to an already cleared device, not novel performance claims.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of 'cases' or 'patients'. The testing is mechanical (on the device itself) rather than clinical. The "sample" would refer to the number of devices or test coupons subjected to the specified ASTM mechanical tests. This information is typically detailed in the full test reports, not usually summarized in this 510(k) format.
• Data Provenance: The document does not specify country of origin for the mechanical testing data. It is inherently "retrospective" in the sense that the justification relies on the established performance of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical device, not one requiring expert human interpretation of medical images or data for ground truth establishment. The "ground truth" for this device's performance is objective mechanical testing per engineering standards (ASTM F 2077-18).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. As no expert review or human interpretation is involved in establishing performance, no adjudication method is necessary.

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 does not involve AI or human readers for diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device does not have a software algorithm component.

7. The type of ground truth used:

• For mechanical performance: Objective engineering standards and test results from the ASTM F 2077-18 standards.
• For biocompatibility: Identity to previously cleared materials and manufacturing processes from predicate device K182584.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this device does not utilize machine learning or AI.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set.

Ask a specific question about this device