(72 days)
The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
The Alamo C is designed for use as a cervical intervertebral body fusion device. 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 an anterior (ACIF) surgical approach. The device is available in various axial footprints and 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.
Here's an analysis of the provided text regarding the Alamo C device, focusing on the requested information:
Summary of Acceptance Criteria and Study Details for Alamo C
The provided text describes a 510(k) submission for the "Alamo C" intervertebral body fusion device. Crucially, this submission is for minor modifications (additional axial footprints) to an already cleared device. Therefore, the "study" described is a mechanical performance study to demonstrate that these modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. This is not a clinical study involving human subjects or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Mechanical performance in accordance with ASTM F2077 | "The device functioned as intended and the performance results show that the modified Alamo C is substantially equivalent to the predicate device." |
| No alteration to the worst-case scenario of the device due to modifications | "Performance testing was conducted to confirm the modification did not alter the worst case scenario of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Performance testing" and "mechanical testing." For mechanical testing, this typically refers to a set number of physical samples of the modified device.
- Data Provenance: The data is generated from mechanical testing of the device itself (likely in a lab setting). It is not clinical data from human subjects and thus doesn't have a "country of origin" or "retrospective/prospective" designation in the typical sense for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as this is a mechanical performance study, not a clinical study that requires expert judgment for ground truth.
4. Adjudication Method for the Test Set
- This question is not applicable for a mechanical performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This device is an intervertebral body fusion device, not an imaging or diagnostic AI tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this question is not applicable. The Alamo C is a physical medical device (an implant), not an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this study is the established performance standards and criteria defined by ASTM F2077 for intervertebral body fusion devices. The device's performance is compared against these pre-defined mechanical requirements.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is a mechanical test of a physical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. There is no ground truth for a training set in this context.
§ 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.