(353 days)
Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.
Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.
The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.
The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Mechanical Performance: |
- Comparable bending strength
- Comparable torsion strength
- Comparable axial pullout strength | Non-clinical tests performed:
- 4 Point Bending Test
- Torsion Test & Axial Pullout Strength Test
Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
| Sterilization Efficacy: - Achieves sterility for pre-sterilized kits
- Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
- Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
- Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
| Biocompatibility: - Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
| Shelf Life: - Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
- Shelf life (only Neuro Plating System - Sterile Kit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
- Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.
7. The Type of Ground Truth Used
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.
8. The Sample Size for the Training Set
- Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" for this 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).