Search Results

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.

Ask a specific question about this device

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 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. 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 provided text is a 510(k) summary for the Lucent® XP intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through technical comparisons and non-clinical testing. It explicitly states that no acceptance criteria or studies proving device performance against such criteria are presented in this document.

The document details the following about the device's evaluation:

1. Acceptance Criteria and Reported Device Performance:

   • No specific acceptance criteria (e.g., in terms of clinical outcomes, accuracy, or specific performance metrics) are mentioned in this 510(k) summary.
   • The document states: "All data indicates that the device will perform as intended." This is a general statement and not a specific performance metric against a defined acceptance criterion.

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

   • No clinical or standalone performance test sets are mentioned. The "non-clinical testing" refers to mechanical tests of the device itself (hardware). The sample sizes for these mechanical tests are not provided.
   • Data provenance is not applicable as no clinical or image-based studies are referenced.

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

   • Not applicable, as no expert-reviewed test sets (e.g., for image interpretation or diagnosis) were used. The evaluation was based on mechanical testing of the physical device.

4. Adjudication method for the test set:

   • Not applicable, as no expert-reviewed test sets were used.

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:

   • No MRMC or human-in-the-loop studies were performed. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the mechanical testing, the "ground truth" would be the engineering specifications and recognized industry standards (ASTM F 2077-14) against which the device performance was measured.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable.

Summary of Device Evaluation (based on the provided text):

The evaluation for the Lucent® XP intervertebral body fusion device primarily relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies or performance against specific acceptance criteria.

• Mechanical Testing:

  • Performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device."
  • Included:
    • Static and Dynamic Compression Testing per ASTM F 2077-14
    • Static and Dynamic Compression Shear Testing per ASTM F 2077-14
  • The document states: "All data indicates that the device will perform as intended."

• Biocompatibility Testing: The materials and manufacturing processes were stated to be identical to previously cleared devices (K152011), thus no new biocompatibility testing was reported.

• No Electrical Safety, Software Verification, Animal Studies, or Clinical Studies were performed.

Ask a specific question about this device