(56 days)
The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with 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 one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.
The provided document is a 510(k) premarket notification letter and summary for the LEGEND Spine CORNICE Cervical Spacer System. This document describes a medical device, which is a physical implant, not an AI/ML powered device. As such, it does not include information typically sought for AI/ML devices regarding acceptance criteria, performance studies involving AI, human experts, and ground truth establishment in the way an AI/ML product would.
The performance testing described is mechanical testing for the physical implant to ensure its structural integrity and safety. Therefore, I cannot extract the information required for an AI/ML device from this document.
For completeness, I can describe the type of acceptance criteria and performance testing that were included for this physical device:
Acceptance Criteria and Reported Device Performance (Physical Device - Mechanical Testing)
| Acceptance Criteria Type | Performance Test/Standard |
|---|---|
| Structural Integrity | Static and dynamic axial compression |
| Stability/Resistance to Shear | Static and dynamic compression shear |
| Resistance to Dislodgement | Expulsion testing |
| Resistance to Sinkage | Subsidence testing |
| Result | The device meets or exceeds the performance of predicate devices according to ASTM F2077-14, ASTM F2267-04, and the Class II Special Controls Guidance Document. |
Missing Information (as this is not an AI/ML device):
- Sample size used for the test set (no test set in the AI/ML sense)
- Data provenance (not applicable for mechanical testing)
- Number of experts used to establish ground truth (not applicable)
- Qualifications of those experts (not applicable)
- Adjudication method (not applicable)
- Multi-reader multi-case (MRMC) comparative effectiveness study (not applicable)
- Effect size (not applicable)
- Standalone performance (not applicable)
- Type of ground truth (not applicable)
- Sample size for the training set (not applicable)
- How ground truth for the training set was established (not applicable)
The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is standard for intervertebral body fusion devices. It does not involve any AI/ML components where ground truth and human-in-the-loop performance would be relevant.
§ 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.