(54 days)
The Alamo P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a posterior approach.
The Alamo P is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a posterior (PLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.
The manufacturer conducted mechanical testing to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria (Predicate) | Reported Device Performance (Alamo P) |
|---|---|---|
| Static Compression | Met requirements of ASTM F2077 and F2267 | Functioned as intended; substantially equivalent to predicate device |
| Dynamic Compression | Met requirements of ASTM F2077 and F2267 | Functioned as intended; substantially equivalent to predicate device |
| Subsidence | Met requirements of ASTM F2077 and F2267 | Functioned as intended; substantially equivalent to predicate device |
| Expulsion | Met requirements of ASTM F2077 and F2267 | Functioned as intended; substantially equivalent to predicate device |
2. Sample Size and Data Provenance for Test Set:
The submission states "worst case device" was used for mechanical testing. No specific sample sizes for repeat tests are provided. Given the nature of mechanical testing, samples would likely be manufactured in the country of origin of the device (not explicitly stated, but the contact person is in the US) and tested in a laboratory. This is a laboratory-based, prospective test.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is an intervertebral body fusion device and its performance is evaluated through mechanical testing, not through expert-labeled diagnostic data.
4. Adjudication Method for Test Set:
Not applicable. Mechanical testing does not involve human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a physical device, not an AI or diagnostic tool requiring human reader studies.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical device, not an algorithm. Its performance is assessed through its mechanical properties and structural integrity.
7. Type of Ground Truth Used:
The ground truth is based on the established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 (Standard Test Methods for Static and Dynamic Axial Compression Fatigue Properties of Spinal Arthrodesis Implants) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). The predicate device's performance against these standards serves as the benchmark for substantial equivalence.
8. Sample Size for Training Set:
Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable.
§ 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.