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Lucent® XP 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 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.

Lucent® XP intervertebral body fusion 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) premarket notification acceptance letter from the FDA for a medical device called Lucent® XP, an intervertebral body fusion device. The document states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

However, the provided text does not contain any information about acceptance criteria for a study, nor does it describe a study that proves the device meets specific acceptance criteria related to its performance.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's decision that the Lucent® XP device is substantially equivalent to predicate devices.
• Device Description: Briefly outlining the device's design and intended use.
• Indications for Use: Specifying the conditions and patient population for which the device is intended.
• Technological Characteristics: Stating similarities to predicate devices.
• Performance Data (Mechanical Testing): Mentioning that non-clinical mechanical testing was performed in accordance with FDA guidance and ASTM standards, demonstrating substantial equivalence to predicate devices. It does not provide the results of this testing, nor does it define acceptance criteria for these tests or compare results against them.
• Substantial Equivalence: Listing the predicate devices to which Lucent® XP was deemed substantially equivalent.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your prompt, I would need a document that describes:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity for an AI device; or specific mechanical thresholds for a physical device).
• Quantitative acceptance criteria for these metrics.
• The results of a study (clinical or non-clinical) that explicitly reports these metrics and compares them against the established acceptance criteria.
• Details about the study's methodology, such as sample size, data provenance, ground truth establishment, etc.

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