(255 days)
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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.
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine lumbar interbody fusion device, which may be implanted as a single device via a lateral approach. The Genesys Spine Interbody Fusion System implant components are made of polyether ether ketone (Invibio PEEK Optima LT)) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The provided text is a 510(k) summary for the Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System. It states that "PERFORMANCE DATA - Not Required." and describes the rationale for this. Therefore, it does not include information about acceptance criteria or a study demonstrating the device meets such criteria in the way a clinical or performance study would typically generate.
Here's a breakdown of why the requested information cannot be extracted from the provided text, and what is stated about performance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission explicitly states "Performance Data - Not Required." and therefore does not list pre-defined acceptance criteria or report device performance against them.
2. Sample size used for the test set and the data provenance:
- Not Applicable. No test set or associated data provenance (e.g., country of origin, retrospective/prospective) is mentioned because performance data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment occurred as performance data was not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication process is mentioned.
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 device is a physical interbody fusion system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth was established, as no performance study was conducted.
8. The sample size for the training set:
- Not Applicable. This is a physical medical implant; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth in this context.
What the document does say about meeting regulatory requirements/equivalence:
Instead of performance studies, the rationale for substantial equivalence is based on technical characteristics and mechanical analysis:
- Technical Characteristics: The device is made of polyether ether ketone (PEEK Optima LT, ASTM F2026) with tantalum markers (ASTM F560), which are standard materials. Its technological characteristics are similar to the currently cleared predicate device (K103034).
- Performance Data (Mechanical): While clinical performance data was "Not Required," the submission states:
- "FEA analysis and projected area calculations show that a new worst-case device was not created."
- "This analysis tool was validated (calibrated) by the predicate system's mechanical test data and is sufficient to allow for a substantial equivalence designation for the subject device."
- "In addition, the length, width, and height of the Lateral Lumbar Interbody Fusion System implants fall within the scope of devices already cleared per K103034."
Conclusion drawn by the submitter:
"The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is substantially equivalent to the Genesys Spine Apache™ Lumbar Interbody System."
FDA's finding:
The FDA letter confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this 510(k) submission, the device was deemed to meet the required safety and effectiveness standards (by being similar enough to एक already approved device) without needing new, extensive performance data or clinical trials.
§ 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.