(135 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 or anterolateral approach. The Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of nonoperative 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 A.I.S.) implants were developed as implants for the posterior stabilization of the lumbar spinal column. The body is rounded trapezoidal in shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surface of the device has a pattern of teeth to provide increased stability and inhibit movement of the implant.
Here’s an analysis of the provided text regarding the A-Wedge Anterior Interbody System, detailing the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Purpose / Standard | Reported Device Performance | Comments on Meeting Criteria |
|---|---|---|---|
| Static Compression | ASTM F2077 | Equivalent to predicate devices | Met by demonstrating equivalence to established predicate devices through physical testing. |
| Dynamic Compression | ASTM F2077 | Equivalent to predicate devices | Met by demonstrating equivalence to established predicate devices through physical testing. |
| Subsidence | ASTM F2267 | Equivalent to predicate devices | Met by demonstrating equivalence to established predicate devices through physical testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical studies were performed." Therefore, there is no "test set" in the context of clinical data, sample size, or patient provenance. The testing conducted was non-clinical (mechanical) on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set or ground truth established by experts for performance evaluation. The "ground truth" for non-clinical mechanical testing would be the physical properties and performance characteristics of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set.
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
Not applicable. This is a medical device (spinal implant), not an AI/imaging diagnostic tool. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (spinal implant), not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the ground truth was the established mechanical performance and safety specifications of the predicate devices. The A-Wedge A.I.S. demonstrated "equivalence" to these predicate devices based on the test results.
8. The Sample Size for the Training Set
Not applicable. No clinical studies were performed, and this is not a machine learning/AI device that requires a training set. The "design input" for the device would be the specifications and performance of the predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set as this is not a machine learning/AI device. The "ground truth" for the device's design and expected performance was established by the existing, legally marketed predicate devices. The study aimed to demonstrate that the A-Wedge A.I.S. met the established performance characteristics of these predicates.
§ 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.