(283 days)
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).
The manufacturer conducted non-clinical testing of the GS Medical AnyPlus PEEK Lumbar Cage to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| ASTM F2077-03 | Complied |
| ASTM F2267-04 | Complied |
| Static Axial Compression | Complied |
| Dynamic Axial Compression | Complied |
| Static Compression-Shear Testing | Complied |
| Dynamic Compression-Shear Testing | Complied |
| Static Torsion Testing | Complied |
| Dynamic Torsion Testing | Complied |
| Expulsion Testing | Complied |
| Static Subsidence testing under Axial Compression (per ASTM F2267) | Complied |
2. Sample Size Used for the Test Set and Data Provenance:
No specific "test set" in the context of clinical data (e.g., patient data, images) was used or reported in this 510(k) summary. The testing was non-clinical, focusing on the mechanical performance of the device itself. Therefore, concepts like country of origin or retrospective/prospective do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a non-clinical, mechanical performance study based on established ASTM standards, not clinical ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical ground truth requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No. This was a non-clinical evaluation of a medical implant's mechanical properties, not an AI-assisted diagnostic device requiring an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an intervertebral body fusion cage and does not involve any algorithm or AI for standalone performance evaluation in this context.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was defined by the ASTM (American Society for Testing and Materials) standards: ASTM F2077-03 and ASTM F2267-04. These standards specify methodologies and acceptance criteria for mechanical testing of intervertebral body fusion devices.
8. The Sample Size for the Training Set:
Not applicable. There was no "training set" as this was a non-clinical evaluation, not a machine learning or AI study.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There was no "training set" or need for establishing ground truth for such a set in this non-clinical testing.
§ 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.