(112 days)
The Gamma3 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
The U-Blade Lag Screw is also indicated for rotationally unstable fractures.
The Gamma3 System consists of Trochanteric Nails, Long Nails, standard Lag Screws, U-Blade Lag Screws, end caps, set screws, distal locking screws, and instrumentation. The purpose of this traditional 510(k) is to update and consolidate system indications and intended use, update MR labeling to reflect new testing, update the mechanical testing analysis, and reference Ø5mm IMN Screws System Locking Screws as compatible components. Additional labeling changes were also made, including operative technique consolidation, safety information updates, and the addition of the MR Conditional symbol to package labels.
This document is a 510(k) premarket notification for the Stryker Trauma GmbH Gamma3 System, an intramedullary fixation rod system. This device is not an AI/ML device, and therefore does not have acceptance criteria, a study that proves the device meets acceptance criteria, test set information, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance information.
Here's the relevant information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalence to predicate devices in: | Mechanical Performance: Testing demonstrated that the Gamma3 System is substantially equivalent in mechanical performance to the Zimmer Natural Nail System (K172114). |
| Construct Fatigue Testing | Met (Implied by substantial equivalence) |
| Lag Screw Cut-Out testing | Met (Implied by substantial equivalence) |
| MR Compatibility: Per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" (December 11, 2014) and the following standards: | MR Compatibility: MR labeling updated to reflect new testing; MR Conditional symbol added to package labels. |
| Magnetically Induced Displacement Force per ASTM F2052 | Met (Implied by updated MR labeling and substantial equivalence) |
| Magnetically Induced Torque per ASTM F2213 | Met (Implied by updated MR labeling and substantial equivalence) |
| Heating by RF Fields per ASTM F2182 | Met (Implied by updated MR labeling and substantial equivalence) |
| Image Artifacts per ASTM F2119 | Met (Implied by updated MR labeling and substantial equivalence) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This document refers to non-clinical laboratory testing, not clinical studies with human test sets. The "test set" for mechanical and MR compatibility testing would refer to the physical devices tested, but specific quantities are not provided in this summary.
- Data Provenance: Not applicable for human data. The non-clinical testing was performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through expert review of data/images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This device is a medical implant, and its performance is evaluated through mechanical and materials testing, not through adjudication of human perceptions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical implant (intramedullary fixation rod system), not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm or AI/ML product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Not applicable in the context of expert review or diagnostic accuracy. For mechanical and MR compatibility testing, the "ground truth" would be established by the physical properties and behavior of the materials and device under controlled laboratory conditions, as defined by recognized industry standards (e.g., ASTM F2052, F2213, F2182, F2119) and FDA guidance.
8. The sample size for the training set:
- Not applicable. This device is a medical implant, not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a medical implant, not an AI/ML product.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.