(122 days)
The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
The Stryker Universal Neuro 3 System comprises of an aluminum module which houses a comprehensive selection of plates, meshes, screws and instrumentation needed to fixate cranial bone flaps. Currently, all devices are provided non-sterile and require cleaning and sterilization prior to implantation. All implants (plates and screws) are single use devices whereas all instruments except for drills (screwdriver handle, blade) can be reused.
Here's an analysis of the acceptance criteria and study information for the Stryker Universal Neuro 3 System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on modifications to an existing device (Stryker Universal Neuro 3 System, K112557). Therefore, the "acceptance criteria" and "reported device performance" are primarily related to proving that these modifications do not negatively impact the safety and effectiveness of the device and that the new features meet specific standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL): SAL of 10⁻⁶ | Achieved through Sterilization validation testing. |
| Residual (Cleaning): Assurance of reliable cleaning | Confirmed through Residual testing. |
| Pyrogenicity: Absence of pyrogenic substances | Confirmed through Pyrogenicity testing. |
| Cytotoxicity: Absence of cytotoxic effects | Confirmed through Cytotoxicity testing. |
| Packaging and Sealing Validation: Sterility maintained throughout shelf life, considering shipping stresses | Confirmed through Packaging and Sealing validation. |
| MRI Compatibility: Displacement Force | Confirmed through MRI compatibility testing. |
| MRI Compatibility: Torque | Confirmed through MRI compatibility testing. |
| MRI Compatibility: Artifacts | Confirmed through MRI compatibility testing. |
| MRI Compatibility: Heating under magnetic resonance environment | Confirmed through MRI compatibility testing. |
| Equivalence to Predicate Device (K112557): Same design, dimensional specifications, and material compositions as the pre-modified version. | Stated that the modified system will have the "exact same design," "same set of plates and screws in same dimensional specifications," and "no change in material compositions" as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets (e.g., number of units tested for sterility, packaging, or MRI compatibility). It mentions "various verification and validation activities" were performed. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be part of the manufacturer's (Stryker) internal testing and documentation for FDA approval. The studies are prospective in nature, as they are being conducted to validate the modified device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the studies described. The "ground truth" for these tests (sterility, pyrogenicity, MRI compatibility, etc.) is established by adherence to recognized standards and validated laboratory methodologies, not by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists assessing medical images). This is not relevant to the laboratory-based and engineering performance testing described for this medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to AI-powered diagnostic devices where human readers' performance with and without AI assistance is being evaluated. The Stryker Universal Neuro 3 System is a surgical implant/fixation system, not a diagnostic AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This is also inapplicable as the device is a hardware implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria listed above is based on:
- Established Standards and Regulations: For sterility (SAL of 10⁻⁶), pyrogenicity, cytotoxicity, and packaging integrity, there are well-defined international and national standards (e.g., ISO standards, FDA guidance) that dictate the test methods and acceptable limits.
- Engineering Specifications: For MRI compatibility, the ground truth is based on the physical properties of the materials and device design, evaluated against established safety limits for the MRI environment.
- Predicate Device Performance: A significant aspect of the "ground truth" is that the modified device must perform equivalently to its predicate device (K112557), which was already deemed safe and effective.
8. The Sample Size for the Training Set
There is no "training set" in the context of this device. A training set is used for machine learning algorithms. The Stryker Universal Neuro 3 System is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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).