Search Results

The Alamo T device 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 transforaminal approach.

The Alamo T device 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. Supplemental fixation and autograft is required to facilitate fusion.

The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths 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 purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

The provided document is a 510(k) premarket notification for a medical device called the "Alamo T Intervertebral Body Fusion Device." This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. In such submissions, the acceptance criteria and study data are presented somewhat differently than for a novel device undergoing clinical trials.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission asserting substantial equivalence (SE) for modifications to an existing device and new sizes, the "acceptance criteria" are intrinsically tied to demonstrating that the new device performs similarly to, or no worse than, the predicate device, especially concerning mechanical and biological integrity. The performance is assessed against the established safety and efficacy of the predicate, rather than novel clinical endpoints.

2. The device's ability to maintain structural stability at the fusion site following discectomy is preserved.
3. The risk of migration or back-out is not increased. | "Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary."

The FMEA (Failure Modes and Effects Analysis) would identify potential failure modes due to changes and assess their mitigation. The engineering rationale would involve comparing the mechanical characteristics of the new sizes/designs to the predicate, likely using established biomechanical principles and potentially referencing existing test data for the predicate.

Specific performance metrics (e.g., stiffness, compressive strength, torsional stability) against a target (e.g., "equal to or greater than predicate") are implied but not explicitly stated in this summary. |
| Biocompatibility & Material Safety | The materials used (PEEK Optima® LT1 and Tantalum markers) are biocompatible and safe for long-term implantation, consistent with established materials in the predicate devices and per relevant ASTM standards. | The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. These are the same materials as the predicate. This reliance on established materials compliant with ASTM standards implies biocompatibility and material safety are met. No new testing explicitly detailed, relying on existing material characterization. |
| Functional Equivalence (Graft Accommodation, Fixation) | 1. The hollow center accommodates bone graft effectively.
2. Inferior and superior surfaces with ridges ("pyramid pattern" and "teeth") improve fixation and stability and prevent back-out and migration.
3. Graft volume and window size are adequate and comparable to appropriate predicates. | "The device footprint has a hollow center to accommodate bone graft..." and "the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration."

The document states: "Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows." This indicates comparison to established functional benchmarks in similar devices. New sizes were validated using Life Spine's PLATEAU system as a "dimensional predicate." The "Teeth" feature is also compared to the predicate Alamo T. |
| Indicated Use & Clinical Application | The device performs its intended function for spinal fusion in skeletally mature patients with DDD at L2-S1, requiring supplemental fixation and autograft, implanted via a transforaminal approach, without altering the fundamental scientific technology or increasing risks. | "The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology." The "Indications for Use" statement is identical to the predicate (K120401). This statement implicitly confirms that the device is expected to perform equivalently in a clinical setting based on its design and material similarity and validated mechanical properties. No clinical testing was required to demonstrate substantial equivalence, implying the modifications are considered minor enough not to necessitate new human studies. |
| Sterilization & Radiographic Visualization | 1. Sterilization method (steam by end user) is effective and validated.
2. Tantalum markers allow for adequate radiographic visualization. | Sterilization: "End User (Steam)" - stated to be the same as the predicate.
Radiographic Markers: "Yes" - stated to be the same as the predicate. The use of ASTM F560 compliant tantalum implies established radiographic visibility. |

Note: For 510(k) clearances, "acceptance criteria" are not always explicit performance thresholds like in a clinical trial. Instead, they are often about demonstrating that the modifications do not introduce new safety concerns or alter the fundamental technology such that the device is no longer substantially equivalent to a legally marketed predicate. The "study" described is primarily non-clinical: FMEA, FEA, and engineering rationale based on predicate comparisons.

Study Details from the Document:

Due to the nature of this 510(k) submission (a line extension with dimensional modifications), the "study" described is primarily non-clinical.

2. Sample Size Used for the Test Set and the Data Provenance:

• Test Set Sample Size: Not applicable. No physical "test set" of devices was used for direct comparative bench testing in the provided summary for performance. The "test set" here refers to the new sizes and dimensional modifications themselves that were analyzed via FMEA, FEA, and engineering rationale.
• Data Provenance: The data provenance is internal engineering analysis and comparison to existing data/specifications of predicate devices. This is not external patient data (e.g., country of origin). The evaluation is based on component-level design and material properties. The analysis is prospective in the sense that it's evaluating the proposed changes before marketing, but it leverages retrospective data/knowledge from predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not specified. "Engineering rationale" implies input from qualified engineers or biomechanical experts within the manufacturer's team or consultants.
• Qualifications: "Quality and Regulatory Consultant" (Kellen Hills) and "Frank Morris (Alliance Partners, LLC)" are listed as contact persons. The FMEA and FEA would be conducted by engineers with relevant expertise (e.g., mechanical engineering, biomechanics). Specific qualifications are not detailed beyond their roles.

4. Adjudication Method for the Test Set:

• Not applicable as there was no independent clinical or expert review of a "test set" of cases. The assessment was internal through FMEA and FEA. This is a technical assessment rather than a clinical adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This type of study is for evaluating human performance influenced by a diagnostic aid (AI), which is not the nature of this interbody fusion device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI does not apply. The "standalone" performance here relates to the mechanical properties of the device itself, which were evaluated via FEA and engineering rationale, not algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical assessment, the "ground truth" is a combination of:
  • Established mechanical properties and design specifications of the predicate devices.
  • Biomechanical principles and engineering calculations.
  • Regulatory standards (e.g., FDA's 2007 Special Controls guidance for Intervertebral Body Fusion Devices, ASTM F2026 for PEEK, ASTM F560 for Tantalum).
  • Clinical experience and safety profiles of the predicate devices (implied by their prior clearance and market use).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of an algorithm or AI system for a physical implant device submission like this. If we consider analogous concepts, the "training" for demonstrating substantial equivalence comes from the extensive historical data, design principles, and performance of existing predicate devices, which allows for leveraging FMEA/FEA rather than requiring de novo testing.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set as understood in AI/algorithm development, the concept of establishing ground truth for it doesn't apply. The device's "ground truth" (its safety and effectiveness claim) is based on its similarity to legally marketed devices whose safety and effectiveness have already been established through prior regulatory review and clinical use.

Ask a specific question about this device