(180 days)
The Genesys Spine Apache@ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1, in skeletally mature patients who 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 1 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.
The Genesys Spine Apache® Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine interbody fusion device, which may be implanted as a single device via:
- Bi-laterally via a posterior (PLIF) approach ■
- As a single device via a transforaminal (TLIF) approach or ■
- I As a single device via an anterior/anterolateral (ALIF) approach.
The 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.
This document is a 510(k) summary for the Genesys Spine Apache® Interbody Fusion System, which is a medical device. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to other legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Subsidence (per ASTM F2267-04) | The Genesys Spine Apache® Interbody Fusion System was tested in static subsidence per ASTM F2267-04. The results, combined with Cross-Sectional Area calculations and validated FEA analysis, showed that a new worst-case device was not created when compared to the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation. |
| Static Expulsion (per ASTM draft standard F-04.25.02.02) | The Genesys Spine Apache® Interbody Fusion System was tested in static expulsion per ASTM draft standard F-04.25.02.02. The results, combined with Cross-Sectional Area calculations and validated FEA analysis, showed that a new worst-case device was not created when compared to the predicate Genesys Spine Interbody Fusion System (K103034). The performance data were sufficient to allow for a substantial equivalence designation. |
| (Implied) Equivalent technological characteristics to predicate devices | The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line (predicate devices). The overall technology characteristics lead to the conclusion of substantial equivalence. |
Limitations: The document does not explicitly state numerical acceptance criteria for static subsidence or expulsion. Instead, it relies on a comparative assessment against a predicate device, aiming to demonstrate that a "new worst-case device was not created" and that the performance data were "sufficient to allow for a substantial equivalence designation."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that the system "was tested" but does not provide details on the number of individual devices or tests conducted for static subsidence and static expulsion.
- Data Provenance: The studies are laboratory-based mechanical performance tests. The country of origin for the data is not explicitly stated but can be inferred as the "Submitter's Address" (Austin, Texas, USA) or the location of the testing facility. The data is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. This submission is for a physical medical device (intervertebral fusion system) and the "ground truth" is established through engineering and mechanical testing standards (ASTM F2267-04, ASTM draft standard F-04.25.02.02, FEA analysis), not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in expert opinions. The presented studies are mechanical tests, governed by standardized protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant to the type of device and studies described in this document. This typically applies to diagnostic devices where the performance of human readers (e.g., radiologists) is evaluated with and without AI assistance. This document describes a surgical implant and its mechanical properties.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This question is not applicable. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is based on established engineering and mechanical standards and comparative analysis to predicate devices. Specifically:
- ASTM F2267-04 for static subsidence.
- ASTM draft standard F-04.25.02.02 for static expulsion.
- Cross-Sectional Area calculations.
- Validated FEA (Finite Element Analysis).
- The performance of the legally marketed predicate devices.
There is no "expert consensus," "pathology," or "outcomes data" specifically used to establish the "ground truth" for these mechanical tests in the context of this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set." The studies performed are mechanical tests for a physical implant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device submission.
§ 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.