(324 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 autogenous 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® XP 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 Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. 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 device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.
This document describes the Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®). However, it does not contain detailed acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices.
Instead, this is a 510(k) Premarket Notification for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device. The "performance data" section focuses on mechanical and physical testing rather than clinical performance or comparisons of human readers with and without AI assistance.
Therefore, I cannot provide all the requested information, specifically regarding AI-related aspects (like MRMC studies, standalone algorithm performance, AI training/test sets, expert qualifications for ground truth in an AI context).
Here's an breakdown of the available information based on your request, explicitly noting what is not applicable (N/A) or not provided (N/P) in this document for the requested AI-centric details:
Device Name: Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®)
Device Type: Intervertebral Body Fusion Device (Spinal Implant)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|---|
| Mechanical Testing | Static Compression | Per ASTM F 2077-14 | "All data indicates that the device will perform as intended." | (Specific values/pass/fail not detailed in this summary.) |
| Dynamic Compression | Per ASTM F 2077-14 | "All data indicates that the device will perform as intended." | (Specific values/pass/fail not detailed in this summary.) | |
| Subsidence Testing | Per ASTM F 2267-11 | "All data indicates that the device will perform as intended." | (Specific values/pass/fail not detailed in this summary.) | |
| Static & Dynamic Compression Shear | Per ASTM F2077-14 | "All data indicates that the device will perform as intended." | (Specific values/pass/fail not detailed in this summary.) |
Explanation: For this type of device (spinal implant), acceptance criteria are primarily based on meeting the performance specifications outlined in relevant ASTM standards for mechanical integrity, rather than clinical efficacy metrics like sensitivity/specificity for an AI algorithm. The document states that "All data indicates that the device will perform as intended," implying successful adherence to these standards, but does not provide quantitative results or detailed pass/fail thresholds within this summary.
Regarding AI/ML-specific Study Information:
This document is for a physical medical device (spinal implant), not an AI/ML algorithm. Therefore, the following points are not applicable (N/A) or not provided (N/P) as they pertain to AI/ML device evaluations.
2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method for the test set: N/A (Not an AI/ML device)
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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device; for spinal implants, "ground truth" would be related to physical properties and functionality confirmed by engineering tests and potentially predicate device history / clinical literature)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)
Summary of this Document's Approach:
This 510(k) submission leverages the concept of substantial equivalence. The manufacturer demonstrates that the Lucent® XP and Lucent XP Ti-Bond® device has the same indications for use, manufacturing method, raw materials, and operating principles as several legally marketed predicate devices. The "Performance Data" section confirms that the device has undergone standard mechanical tests (Static Compression, Dynamic Compression, Subsidence, Compression Shear) according to specific ASTM standards, and the results indicate it performs as intended. This type of testing is standard for implantable devices to ensure structural integrity and biocompatibility, rather than diagnostic accuracy as would be required for an AI/ML system.
§ 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.