(161 days)
The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-TI) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone.
This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
The icotec Cervical Cage is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a Ti-iT® rough CP-titanium coating. The devices are intended to be used with supplemental spinal fixation. Each cage is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.
This document is a 510(k) summary for the icotec Cervical Cage, which is a medical device. The document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared devices.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format typical of an AI algorithm's performance. Instead, it focuses on demonstrating that the icotec Cervical Cage (subject device) is substantially equivalent to predicate devices. The performance criteria for "substantial equivalence" are based on a comparison of indications for use, design, materials, function, and manufacturing.
The performance testing summarized relates to mechanical properties, not clinical outcomes directly measured against specific numeric criteria for the device itself.
| Acceptance Criteria Category (Implied by Substantial Equivalence and Testing) | Reported Device Performance Summary |
|---|---|
| Mechanical Performance | Demonstrated equivalence and performance through benchtop mechanical testing. |
| - Static axial compression | Testing performed per ASTM F2077 and ASTM F2267. |
| - Dynamic axial compression | Testing performed per ASTM F2077 and ASTM F2267. |
| - Static compression-shear | Testing performed per ASTM F2077 and ASTM F2267. |
| - Dynamic compression-shear | Testing performed per ASTM F2077 and ASTM F2267. |
| - Static torsion | Testing performed per ASTM F2077 and ASTM F2267. |
| - Dynamic torsion | Testing performed per ASTM F2077 and ASTM F2267. |
| - Expulsion | Testing performed per ASTM F2077 and ASTM F2267 (for the original cage) and additional expulsion testing for the lordotic version. |
| - Subsidence | Testing performed per ASTM F2077 and ASTM F2267. |
| Wear Particle Analysis | Testing performed as per ASTM F1877. |
| Coating Characterization & Performance | Testing performed as per ISO 13179, ASTM F1160, ASTM F1044, ASTM F1147, and ASTM F1978. |
| Risk Analysis (for new features) | Performed for the inclusion of the lordotic version. |
| Clinical Performance (for expanded indications) | Comprehensive clinical literature review performed to show clinical performance and success of representative cervical cages in 2 or more levels of the cervical spine. (This refers to prior studies on similar devices, not a new study on the icotec Cervical Cage specifically for multi-level use). |
| Overall Substantial Equivalence | The subject device was demonstrated to be substantially equivalent to predicates cited with respect to indications, design, materials, function, manufacturing, and performance. This is the primary "acceptance criterion" for 510(k) clearance, and it was met. |
2. Sample Size Used for the Test Set and Data Provenance:
- Mechanical Testing: Not specified in terms of "sample size" for a test set in the way one would for a clinical study. These are benchtop tests. The standards (ASTM, ISO) typically define the number of samples required for each test. The document does not provide the specific number of units tested.
- Clinical Literature Review: No specific "test set" was used for the subject device. Instead, a "comprehensive clinical literature review" was conducted on representative cervical cages. The data provenance would be from the published literature, which could include retrospective and prospective studies from various countries. The document does not specify the origin or type of studies included in this review.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this document. The FDA 510(k) clearance process for this medical device (intervertebral body fusion device) relies primarily on demonstrating substantial equivalence through mechanical testing and a review of existing clinical literature for similar devices. There is no mention of human experts establishing a "ground truth" for a test set in the context of an AI device or diagnostic tool.
4. Adjudication Method for the Test Set:
This information is not applicable. Since there is no human-interpreted "test set" in the context of an AI algorithm or diagnostic tool described here, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (an implantable cage), not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of human readers improving with 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. This is not an AI algorithm.
7. The Type of Ground Truth Used:
- For Mechanical Testing: The "ground truth" is established by the specifications and tolerances defined by the relevant ASTM and ISO standards for properties like compression, shear, torsion, expulsion, wear, and coating characteristics.
- For Expanded Clinical Indications (multi-level use): The "ground truth" (or supporting evidence) for the clinical performance aspect was based on a "comprehensive clinical literature review" of existing data from representative cervical cages. This relies on published outcomes data from those prior studies.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable. As there is no training set mentioned.
§ 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.