(446 days)
Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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, anterior plate 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.
This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, 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 modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.
The provided text describes a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment, which are typical for studies validating AI/ML models or novel devices requiring extensive clinical data, is not directly applicable in the context of this 510(k) submission.
Here's an explanation based on the provided document and why most of your requested fields cannot be filled:
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Nature of the Device: The Lucent® and Lucent Magnum® are physical intervertebral body fusion devices, not AI/ML systems or diagnostic tools. Their performance is assessed through mechanical testing against established ASTM standards and comparison to predicate devices, not through clinical studies with "test sets," "ground truth experts," or "AI assistance effect sizes."
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510(k) Process: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predecessor. The primary method for proving this "substantial equivalence" is through comparison of material specifications, design features, intended use, and performance data (often mechanical testing for implants) against predicate devices. Clinical efficacy studies as you've described for AI models are generally not required for 510(k)s unless the device raises new safety or effectiveness questions not addressed by predicates.
Therefore, many of your specific questions are not addressed in this type of regulatory document. I will fill in what can be inferred or directly stated from the text.
Acceptance Criteria and Device Performance (for a physical medical device)
The "acceptance criteria" for this device are implicitly tied to demonstrating performance at least as good as the predicate devices, as measured by standard mechanical tests. The "reported device performance" is a statement that the device did meet these criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance at least as good as previously cleared Lucent system devices (K071724 and K073348) according to ASTM F2077, ASTM F2267, ASTM F1877, ASTM F2025-06. | "A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device." |
| Coating characteristics meeting standards set by ASTM F1044 and ASTM F1147. | "Coating Characterization testing was performed using coupons... All data indicates that the device will perform as intended." |
Study Details and Ground Truth Establishment
Given the nature of a 510(k) for a physical implant, the following information is not applicable or not provided in the document as it would be for an AI/ML diagnostic device study:
- Sample size for the test set: Not applicable. Performance was assessed through mechanical testing of the device itself and components, not a "test set" of clinical cases.
- Data provenance: Not applicable. Mechanical test results do not have "provenance" in the sense of clinical data (country or retrospective/prospective).
- Number of experts used to establish the ground truth for the test set & qualifications: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology). The "ground truth" for mechanical performance is defined by the ASTM standards and the performance of the predicate device.
- Sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
§ 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.