(126 days)
Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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).
These devices are 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 these devices.
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.
The provided text is a 510(k) Premarket Notification for the LUCENT® and LUCENT Ti-BOND® intervertebral body fusion devices. It is a submission to the FDA seeking clearance to market a medical device, demonstrating its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., a specific strength value that must be met). Instead, it relies on demonstrating that the device performs comparably to predicate devices under a set of established tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | Demonstrated the PEEK material's biocompatibility via Invibio device master file (MAF 1209) and the titanium coating material's biocompatibility by reference to ASTM F 1580. No further testing was required. |
| Mechanical Strength (Static Compression): | Testing performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The document implies the device met the requirements of this guidance, performing comparably to the predicate device. |
| Mechanical Strength (Dynamic Compression): | Testing performed in accordance with the FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." The document implies the device met the requirements of this guidance, performing comparably to the predicate device. |
| Substantial Equivalence to Predicate Devices: | The submitter concludes, "Based on our analysis of the test data, the device performs comparably to the predicate device that is currently marketed for the same intended use." This is the overarching "acceptance criterion" for a 510(k) submission. |
| No New Safety/Effectiveness Issues from Modifications: | The document states, "Neither modification raises any new issues of safety or effectiveness." This refers to the introduction of a rounded anterior end and additional line item configurations in the Lucent line. |
| Electrical Safety and EMC: | Not applicable; "No electrical and electromagnetic compatibility testing were performed." |
| Software Verification and Validation: | Not applicable; "The device does not contain software. Therefore no software verification and validation testing were performed." |
| Animal Study: | Not applicable; "No animal studies were performed." |
| Clinical Studies: | Not applicable; "No clinical studies were performed." |
| Compliance with General Controls (e.g., GMP, Labeling): | The FDA letter explicitly notes that the substantial equivalence determination does not mean the device complies with other requirements of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling). These are implicit ongoing requirements for market acceptance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests (Static Compression and Dynamic Compression). It simply states that "Non-clinical testing were used," and lists the types of tests.
- Data Provenance: The document does not provide details about the country of origin for the data or whether it was retrospective or prospective. Given that no animal or clinical studies were performed, the "data" primarily refers to the results of the benchtop mechanical, biocompatibility, and material characterization tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of this 510(k) submission for these types of mechanical and biocompatibility tests. "Ground truth" for mechanical testing is established by engineering standards and validated testing protocols. For biocompatibility, it's established by recognized standards (e.g., ISO 10993-1) and material master files. There's no mention of experts establishing ground truth in the way it would be for, say, a diagnostic imaging study.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers or evaluators make subjective assessments that need to be reconciled, such as in clinical trials or AI performance evaluations involving expert consensus. This document describes benchtop mechanical and material tests, which rely on objective measurements and adherence to standards rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm. The document explicitly states: "The device does not contain software. Therefore no software verification and validation testing were performed."
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" is adherence to established engineering standards and regulatory guidance. The document states that testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This guidance document would define acceptable ranges or performance attributes that the device must meet to demonstrate safety and effectiveness comparable to predicate devices.
For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1) and material master files (e.g., Invibio device master file MAF 1209, ASTM F 1580 for titanium).
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device (intervertebral body fusion device) without software or AI components, there is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above (no training set for a physical device).
§ 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.