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The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.

The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.

This is a 510(k) premarket notification for a medical device, the Alliance Spine RAAS Cranial Plating System. This type of submission is focused on demonstrating substantial equivalence to an existing legally marketed device (predicate device), rather than proving the device meets explicit acceptance criteria through a standalone clinical study like a De Novo application might.

Therefore, the structure of the response will reflect that the "acceptance criteria" are essentially the performance characteristics of the predicate devices, and the "study" is the non-clinical testing demonstrating similar performance.

Acceptance Criteria and Study for the Alliance Spine RAAS Cranial Plating System (K141123)

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly derived from the performance of the predicate devices. The new device is considered substantially equivalent if its performance is comparable.

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

• Test Set Sample Size: The document does not specify a precise sample size for each test (e.g., number of burr hole plates or screws tested). It refers to "Worst case Burr Hole plates" and "Worst case screws," implying a representative selection but not a fixed number.
• Data Provenance: The data is generated from non-clinical bench testing, conducted specifically for this 510(k) submission. The location of the testing is not specified. It is a prospective generation of data for the submission.

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

This information is not applicable (N/A) in this context. For a 510(k) submission, the "ground truth" for mechanical performance is established through adherence to recognized international and national standards (e.g., ASTM F382, ASTM F543) and comparison to the known performance of predicate devices. There wouldn't be a panel of human "experts" establishing a ground truth for mechanical test results in the same way they might for clinical interpretations.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Mechanical testing results are objective measurements against defined standards and predicate performance, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a cranial plating system, a physical implant, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable (N/A). This product is a physical medical device (cranial plating system), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence in this 510(k) is:

• Adherence to recognized industry standards: ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
• Performance metrics of predicate devices: The tests were designed to show that the subject device's mechanical properties (e.g., peak load, stiffness, torque values) were "acceptable based on intended use and predicate data," implying that the predicate's performance served as the benchmark.

8. The Sample Size for the Training Set

This information is not applicable (N/A). As this is a physical medical device without any AI/machine learning components, there is no "training set."

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

This information is not applicable (N/A), as there is no training set for this type of device.

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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.

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.

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