Search Results
Found 1 results
510(k) Data Aggregation
(147 days)
Fortilink-C with TETRAfuse 3D Technology
The Fortilink-C interbody fusion devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Fortilink-C devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc to the C7-T1 disc using autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Fortilink-C devices are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When used as a vertebral body replacement (VBR) device, Fortilink-C devices are for use in the thoracolumbar spine (TI-LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. V BRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The VBR device is intended to be used with autogenous or allogenic bone graft and must be used with supplemental internal fixation systems.
The Fortilink-C IBF/VBR implants are manufactured from radiolucent polyetherketoneketone (PEKK) material (ASTM F2820) in various footprints and sizes. Each implant includes radiographic marker pins from tantalum (ASTM F560) and a central graft containment window. Each implant has insertion slot features on the anterior face to mate with an insertion instrument. The Fortilink-C IBF/VBR implants includes both 0° (parallel) and 6° lordosis, and designs with and without teeth. Class II accessories and Class I (exempt) manual surgical instruments are available for use with the implants.
This document is a 510(k) Summary for the Fortilink™-C with TETRAfuse™ 3D Technology, an intervertebral body fusion (IBF) / vertebral body replacement (VBR) device. It describes the device, its indications for use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with specific thresholds. Instead, it describes non-clinical testing performed to demonstrate "substantial equivalence" and "sufficient" mechanical strength. The "reported device performance" is a qualitative statement that the device met these objectives.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Static and Dynamic Axial Compression and Torsion): Demonstrate mechanical strength comparable to legally marketed predicate devices and sufficient for intended use, in accordance with ASTM F2077. | Mechanical testing showed that the mechanical strength of the subject system is substantially equivalent to the legally marketed predicate devices and sufficient for the intended use. |
| Subsidence Resistance (Static Subsidence): Demonstrate resistance to subsidence, in accordance with ASTM F2267. | Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary. |
| Expulsion Resistance (Static Expulsion): Demonstrate resistance to expulsion, in accordance with Draft Standard Z8423Z (ASTM F-04.25.02.02). | Performed (results contributed to the conclusion of substantial equivalence and sufficient mechanical strength). Specific quantitative results are not provided in this summary. |
| Bacterial Endotoxin Levels: Meet requirements for bacterial endotoxin, in accordance with ANSI/AAMI ST-72. | Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72. (Implied that it met the standard for acceptance). |
| Substantial Equivalence: Demonstrate that the device is substantially equivalent to previously cleared predicate devices in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength, with no significant differences that would affect safety and effectiveness. | This submission supports the position that the subject implants are substantially equivalent to previously cleared predicate devices. The subject and predicate devices are similar in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength. There are no significant differences between the subject and predicate devices that would affect the safety and effectiveness of the Fortilink-C system. Any differences were not considered significant based on mechanical performance, bench testing. |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical (bench) testing of mechanical properties and biocompatibility.
- Sample Size: The document does not specify the exact number of devices or test samples used for each mechanical test (e.g., number of constructs for axial compression). ASTM standards typically require a minimum number of samples (e.g., n=6) for such tests, but this specific detail is not provided in the summary.
- Data Provenance: The data provenance is from bench testing conducted by RTI Surgical, Inc. (Pioneer Surgical Technology, Inc.), not from human clinical data. Therefore, concepts like "country of origin of the data" or "retrospective or prospective" do not directly apply in the context of human studies, as this is a device clearance based on substantial equivalence primarily supported by non-clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device clearance is based on non-clinical engineering and materials testing, not on clinical data requiring expert human review of diagnostic output or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical laboratory testing, not a study involving human readers or interpretation requiring adjudication.
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
Not applicable. This is a medical device clearance for an orthopedic implant, not an AI/CADe/CADx system. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device clearance for an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by the validated and recognized ASTM standards (ASTM F2077, ASTM F2267) and ANSI/AAMI standard (ANSI/AAMI ST-72). The performance of the Fortilink-C device was measured against the criteria and requirements set forth in these standards, and compared to the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study requiring a training set. This is a medical implant requiring mechanical and material testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/machine learning study.
Ask a specific question about this device
Page 1 of 1