(58 days)
When used as a cervical intervertebral body fusion device, the Genesys Spine Interbody Fusion 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-TI 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.
When used as a lumbar intervertebral body fusion device, the Genesys Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin 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.
When used as a vertebral body replacement device, the Genesys Spine System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices 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. The device system is intended to be used with autograft or allograft bone.
The Genesvs Spine Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
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- Genesys Spine cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
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- Genesys Spine lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach:
- as a single device via a transforaminal (TLIF) approach; or ،
- as as a single device via an anterior/anterolateral (ALIF) approach. ﺑ
- Genesys Spine vertebral body replacement device(s), which may be implanted in the thoracic 3) and/or thoracolumbar spine (T1-L5).
The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (PEEK Optima LT1) 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 Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided document is a 510(k) Premarket Notification for a medical device, the Genesys Spine Interbody Fusion System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance thresholds for the Genesys Spine Interbody Fusion System. Instead, the "acceptance criteria" are implied to be demonstrating substantial equivalence to predicate devices by achieving comparable performance in non-clinical mechanical tests. The reported device performance is that the Genesys Spine Interbody Fusion System met these equivalence standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in mechanical testing. | Conclusion: "The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Genesys Spine Interbody Fusion System is substantially equivalent to the predicate device." |
| Specific Tests for Equivalence: | |
| - Static and dynamic compression testing (per ASTM F2077-03) | Conducted in accordance with ASTM F2077-03. Results implicitly deemed comparable to predicates for substantial equivalence. |
| - Static and dynamic torsion testing (per ASTM F2077-03) | Conducted in accordance with ASTM F2077-03. Results implicitly deemed comparable to predicates for substantial equivalence. |
| - Subsidence testing (per ASTM F2267-04) | Conducted in accordance with ASTM F2267-04. Results implicitly deemed comparable to predicates for substantial equivalence. |
| - Expulsion testing (per ASTM Draft Standard F-04.25.02.02) | Conducted in accordance with ASTM Draft Standard F-04.25.02.02. Results implicitly deemed comparable to predicates for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical mechanical testing. For such tests, the "sample size" refers to the number of devices or components tested, not human subjects. The document does not specify the exact number of devices tested for each mechanical test (e.g., how many devices underwent static compression).
Data Provenance: The tests conducted are laboratory-based mechanical tests. Therefore, there is no "country of origin for data" or "retrospective/prospective" distinction in the way it applies to clinical studies involving human subjects. The tests were performed in a controlled laboratory environment to ASTM standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable to the provided document. The "tests" conducted are non-clinical mechanical tests, not diagnostic or interpretative studies requiring expert ground truth establishment. The performance is measured against engineering standards (ASTM).
4. Adjudication Method for the Test Set
This question is not applicable. There is no "adjudication method" in the context of mechanical engineering tests. The results are quantitative measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes non-clinical mechanical tests to demonstrate substantial equivalence for a physical implantable device. It does not involve any human readers or AI in a diagnostic or interpretative capacity, thus no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is relevant for AI/algorithm-based devices. The Genesys Spine Interbody Fusion System is a physical interbody fusion device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical mechanical tests, the "ground truth" or reference performance is derived from the established performance characteristics of the predicate devices as demonstrated by their own testing and regulatory clearance, and the requirements outlined in the ASTM standards (e.g., F2077-03, F2267-04, and the draft F-04.25.02.02). The goal is to show the new device performs comparably to these established benchmarks.
8. The Sample Size for the Training Set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device design is based on engineering principles and material science, not data-driven algorithm training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 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.