(203 days)
The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The A-Wedge Anterior Interbody System (A-Wedge AIS) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. A-Wedge AIS implants are available in two lordotic configurations (6° and 11°) of various heights to restore lumbar lordosis and the associated sagittal balance. SMG A.I.S. implants have three titanium alloy x-ray markers. The A-Wedge AIS device is single-use only.
Materials: Medical grade PEEK (ASTM F2026) machined from Orthoplastics Vertepeek extruded bar stock (FDA master file MAF #1820). Orthoplastics Vertepeek is fabricated from Evonik Degussa medical grade Vestakeep | PEEK granules (FDA master file MAF # 1688). ELI grade titanium alloy (Ti-6Al-4V per ASTM F136) for radio opaque markers.
Function: A-Wedge AIS devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.
This document is a 510(k) Pre-Market Notification for a medical device called the "A-Wedge Anterior Interbody System". It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of AI/software performance. Therefore, most of the requested information regarding AI/software performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and stand-alone performance is not applicable to this type of regulatory submission.
The document focuses on the mechanical and material performance of a physical implant.
Here's an analysis based on the provided text, addressing the relevant points and noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Tests) | Reported Device Performance |
|---|---|
| Mechanical testing per FDA Guidance Document for spinal devices and modified ASTM F2077-03: | All static and dynamic test results met or exceeded the requirements for intervertebral body fusion devices intended for use in the lumbar spine. |
| Static Compression | Met or exceeded requirements |
| Dynamic Compression | Met or exceeded requirements |
| Static Compression-Shear | Met or exceeded requirements |
| Static Torsion | Met or exceeded requirements |
| ASTM F2267-04 (Subsidence) | Met or exceeded requirements |
| Draft ASTM F04.25.02.02 (Expulsion) | Met or exceeded requirements |
| Material change (Orthoplastics Vertepeek vs. Invibio PEEK-OPTIMA) | "show the change in materials for the subject A-Wedge AIS and predicate SpineWork's A-Wedge A.I.S. do not raise new types of safety and efficacy issues;" based on master files MAF # 1688 and #1820. This implies performance equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This document refers to mechanical testing of physical implants, not an AI/software test set. The number of physical units tested is not specified in this summary but would be part of the detailed test reports referenced (e.g., ASTM standards).
- Data Provenance: Not applicable in the context of clinical or AI data. The mechanical testing was performed in accordance with FDA Guidance and ASTM standards.
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)
- Not applicable. This is not a study involving human experts or ground truth in the sense of clinical annotations for AI. Mechanical tests are typically performed by engineers/technicians following standardized protocols, and their "ground truth" is the physical measurement against set thresholds.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication is mentioned as this is mechanical testing, not a clinical or AI performance evaluation.
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 is not an AI-powered device or a study involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical intervertebral body fusion device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For mechanical testing, the "ground truth" is the established quantitative performance requirements defined by industry standards (ASTM F2077, F2267, and draft F04.25.02.02) and FDA guidance for intervertebral body fusion devices. The device's performance is measured against these objective, verifiable thresholds.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this physical device.
§ 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.