(161 days)
When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ 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 (i.e. cleared cervical plating system) and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Genesys Spine Apache™ Cervical Interbody Fusion 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 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™ Cervical Interbody Fusion System. It does not describe an AI/ML device or a study involving human readers. Therefore, most of the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.
However, I can extract the relevant information regarding the performance data that was provided for this medical device and what served as its "acceptance criteria" for substantial equivalence.
Here's a summary based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device conforms to material standards. | The implant components are made of polyether ether ketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560). |
| Mechanical performance, specifically expulsion resistance, is adequate. | Expulsion testing was conducted. |
| Structural integrity and biomechanical equivalence to predicate device. | Cross-Sectional Area calculations and FEA analysis were performed to show that a new worst-case device was not created. This Finite Element Analysis (FEA) tool was validated by the predicate system's mechanical test data. |
| Device dimensions fall within the scope of cleared predicate devices. | The length, width, and height of the Cervical Interbody Fusion System implants fall within the scope of predicate devices already cleared. |
| Overall technological characteristics are equivalent to predicate. | The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line. The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache™ Cervical Interbody Fusion System is substantially equivalent to the legally marketed predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on mechanical testing and analysis, not a clinical study with patients.
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 information is not applicable as the document describes a physical medical device submission based on mechanical testing and material properties, not an AI/ML product requiring expert-established ground truth from images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. See point 3.
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 information is not applicable. This submission is for a physical orthopedic implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance, the "ground truth" (or reference) used was the mechanical test data of the predicate system for validation of the FEA tool, and general ASTM material standards. For design dimensions, the "ground truth" was the dimensions of already cleared predicate devices.
8. The sample size for the training set
This information is not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set mentioned.
§ 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.