(288 days)
The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.
The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.
This document describes the Lucero Medical Cervical Spacer System, an intervertebral body fusion device. The acceptance criteria and performance are based on mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance (Worst Case) |
|---|---|---|
| Static Compression | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Dynamic Compression | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Static Torsion | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Subsidence | ASTM F2267 | Meets standard |
| Expulsion | Not explicitly stated in terms of standard but implied by predicate comparison | Performed and meets criteria (substantially equivalent to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of Lucero Medical Cervical Spacers used in the mechanical testing (the test set sample size). It refers to "worst-case Lucero Medical Cervical Spacer." The data provenance is internal testing performed by Lucero Medical, LLC, to demonstrate substantial equivalence to legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is a medical device for orthopedic surgery, and the "ground truth" for mechanical testing is established by adherence to recognized ASTM standards (F2077, F2267) rather than expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements against established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI or imaging-based diagnostic tool. The performance evaluation is based on mechanical properties and substantial equivalence to existing devices.
6. Standalone Performance Study (Algorithm Only)
No, a standalone performance study was not done as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" used for device performance is based on established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 for static and dynamic compression and static torsion, and ASTM F2267 for subsidence.
8. Sample Size for the Training Set
Not applicable. Mechanical testing of physical devices does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device evaluation.
§ 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.