(302 days)
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.
| Performance Attribute (Implicit Acceptance Criteria based on Predicate Devices) | Alliance Spine RAAS Cranial Plating System Performance (Reported) |
|---|---|
| Mechanical Strength (Static Axial Compression): Peak load and stiffness comparable to predicate burr hole plates. | Peak load and stiffness values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate. |
| Screw Insertion/Removal Torque: Driving torque values comparable to predicate screws. | Driving torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate. |
| Screw Ultimate Torque: Peak torque values comparable to predicate screws. | Peak torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate. |
| Screw Axial Pullout Strength: Peak load values comparable to predicate screws. | Peak load values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate. |
| Material Composition: Use of biocompatible materials (ASTM F136, ASTM F67). | Plates and Burr Hole Covers - ASTM F136; Mesh - ASTM F67; Screws - ASTM F136. All consistent with predicate materials. |
| Dimensions (Thickness): Comparable plate and mesh thicknesses to predicate devices. | Plates & Burr Hole Covers - 0.5mm; Mesh - 0.3mm and 0.6mm. Comparable to predicate range (e.g., 0.25 to 1.0mm, 0.1 to 0.6mm). |
| Sterilization Method: Compatibility with standard sterilization methods. | End User (steam) sterilization. |
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.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).