(168 days)
The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, 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 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 intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Interbody Fusion System (K103034 and K153123). This submission will offer 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 an Anterior or Anterolateral approach.
The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.
The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System implant components are made of polyetheretherketone (Invibio 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 additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.
This document is a 510(k) premarket notification for the Genesys Spine Apache® Anterior Lumbar Interbody Fusion System. It states that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions, noting that this is a medical device with mechanical testing, not an AI/Software as a Medical Device (SaMD), so many of your requested items pertaining to AI model validation (like sample size of test sets, ground truth establishment, MRMC studies, training set details) are not applicable to this document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance, as would be expected for a diagnostic device. Instead, the performance is demonstrated through biomechanical testing to show substantial equivalence to predicate devices.
| Performance Attribute | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Substantially equivalent to predicate devices for intended use. | Static Push-out Test: Performed per ASTM Draft Standard F-04.25.02.02. Results contributed to demonstrating substantial equivalence. |
| Biomechanical Stability | Substantially equivalent to predicate devices for intended use. | Finite Element Analysis (FEA): Performed. Results contributed to demonstrating substantial equivalence. |
| Material Biocompatibility | Conformance to relevant ASTM standards. | Implant components are made of polyetheretherketone (Invibio PEEK Optima LT1) conforming to ASTM F2026. Tantalum markers conform to ASTM F560. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated in terms of a "sample size" of patients or cases. The testing refers to mechanical tests (Static Push-out Test and Finite Element Analysis) which are typically performed on a set of physical devices or computational models, not patient data.
- Data Provenance: Not applicable in the context of patient data. The testing is non-clinical, focusing on the mechanical properties of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is not applicable to this type of device submission. Ground truth and expert consensus are relevant for diagnostic devices that interpret patient data. For a spinal implant, the "ground truth" is typically defined by engineering standards, material specifications, and biomechanical principles, which are evaluated by engineers and materials scientists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable to this type of device submission. Adjudication methods are used for resolving discrepancies in expert interpretations, primarily for diagnostic devices.
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
- This is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools and the impact on human reader performance. This document concerns a physical spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This question refers to the standalone performance of an AI algorithm. The Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or basis for evaluation) for this device is its adherence to established engineering standards (e.g., ASTM F2026 for materials, ASTM Draft Standard F-04.25.02.02 for push-out testing), and its demonstrated mechanical equivalence to predicate devices through non-clinical testing (Static Push-out Test and Finite Element Analysis).
8. The sample size for the training set
- This is not applicable. Training sets are used for machine learning models. This is a physical interbody fusion system.
9. How the ground truth for the training set was established
- This is not applicable. As above, training sets and their ground truth are concepts for machine learning, not for physical medical device submissions like this one.
§ 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.