(306 days)
The Genesys Spine Apache™ IBFD Star Cervical System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Genesys Spine Apache™ IBFD Star Cervical System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine cervical interbody fusion device, which may be implanted as a single device via an anterior approach. The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LTI) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Genesys Spine Apache™ IBFD Star Cervical System is a medical device designed for intervertebral body fusion in the cervical spine. The provided document describes the acceptance criteria and the study conducted to demonstrate the device's substantial equivalence to legally marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Genesys Spine Apache™ IBFD Star Cervical System were based on demonstrating substantial equivalence to predicate devices through non-clinical testing. The performance was evaluated against established ASTM standards for intervertebral body fusion devices.
| Acceptance Criteria (based on ASTM Standards) | Reported Device Performance |
|---|---|
| Static Testing (ASTM F2077-11) | Device was tested in static axial compression and torsion. |
| Dynamic Testing (ASTM F2077-11) | Device was tested in dynamic axial compression and torsion. |
| Subsidence Testing (ASTM F2267-04) | Device was tested for static subsidence. |
| Expulsion Testing (ASTM draft standard F-04.25.02.02) | Device was tested for expulsion. |
| Material Conformance | Implants made of PEEK Optima LTI conform to ASTM F2026. |
| Tantalum Markers | Tantalum markers conform to ASTM F560. |
Conclusion: The reported device performance indicates that the Genesys Spine Apache™ IBFD Star Cervical System met the acceptance criteria by successfully undergoing all specified non-clinical tests according to the relevant ASTM standards. The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This submission pertains to a non-clinical study for a medical implant, not a clinical study involving patient data. Therefore, the concepts of "sample size for the test set," "data provenance (e.g., country of origin of the data, retrospective or prospective)," "number of experts used to establish the ground truth," and "adjudication method" are not applicable in the context of this device's performance evaluation. The "test set" here refers to the physical devices and materials subjected to mechanical and material tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this was a non-clinical evaluation of mechanical and material properties against standardized tests, not a clinical study requiring expert interpretation of patient data. The "ground truth" is defined by the ASTM standards themselves and the measurable outcomes of the physical tests.
4. Adjudication Method for the Test Set
Not applicable, as this was a non-clinical evaluation.
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 implant, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical implant, not an algorithm or software. Its performance is evaluated through physical and material testing.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device was established based on pre-defined engineering standards and material specifications:
- ASTM F2077-11: Standard Test Methods for Intervertebral Body Fusion Devices. This standard defines the acceptable mechanical performance (static and dynamic axial compression and torsion).
- ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression. This standard defines the acceptable subsidence performance.
- ASTM draft standard F-04.25.02.02: Related to expulsion testing (specific details of the draft standard not provided, but it serves as the ground truth for expulsion resistance).
- ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. This standard defines the material properties for the PEEK components.
- ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications. This standard defines the material properties for the tantalum markers.
The device's performance against these quantified, objective standards represents the "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical evaluation of a physical medical implant, not a machine learning model. Therefore, no training set for an algorithm is involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved in the performance evaluation of this physical device.
§ 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.