(107 days)
The GMReis Fibula Nail System is intended for fixation of fractures and osteotomies of the fibula.
The GMReis Fibula Nail System is a system of locked intramedullary nails for osteosynthesis of fibular fractures. It has multiple lengths (110mm to 180mm) and diameters (3.0mm and 3.6mm). The arrangement of the holes in the intramedullary nails allows the surgeon to block the implant in different planes. The screws have a specific profile that reduces the risk of skin prominence and have threaded locking in the nail holes. GMReis Fibula Nail System are manufactured with titanium alloy, are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.
The provided FDA 510(k) Clearance Letter for the "GMReis Fibula Nail System" (K250559) establishes substantial equivalence based on mechanical performance data, not clinical performance or AI/software-driven insights. Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI/software-based device cannot be extracted from this document.
The clearance is for a mechanical medical device (an intramedullary fixation rod), not a software or AI device. The type of acceptance criteria and study design are fundamentally different for a mechanical device versus a software/AI device.
However, I can extract the information relevant to this specific device's clearance process from the provided document:
Acceptance Criteria and Device Performance for GMReis Fibula Nail System (K250559) - A Mechanical Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|---|
| Mechanical Performance | Demonstrated equivalent mechanical properties to the predicate device for fibula fracture fixation. | "The performance of the subject devices are demonstrated through mechanical testing according to ASTM F1264 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate device." |
| Material Equivalence | Material composition to be suitable for implantation and consistent with the predicate device. | "GMReis Fibula Nail System are manufactured with titanium alloy... All of the subject device final finished components are manufactured... using identical materials... as used for the previously cleared reference devices in K201728, K223114 and K232829." Predicate also had titanium, with an option for stainless steel. |
| Biocompatibility | Biologically compatible for human implantation. | "substantially equivalent with regard to materials, packaging and biocompatibility" (stated in comparison to predicate/reference devices). |
| Sterilization | Suitable for sterilization. | "are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use." "are to be sterilized by the same methods" (as predicate). |
| Dimensions/Fit for Use | Appropriate lengths and diameters for fibula fixation, comparable to predicate devices in function. | Minor differences in length and diameter compared to the predicate (predicate has longer, smaller, and larger diameter nails). These differences are deemed "minor and do not affect the safety and effectiveness of the subject device." Predicate's additional stainless steel option is also noted as a minor difference. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices tested, but implicitly refers to a sufficient number of samples to satisfy the requirements of the ASTM standards (ASTM F1264 for Intramedullary Fixation Rods and ASTM F543 for Metallic Medical Bone Screws). These standards outline specific testing configurations and sample numbers for mechanical characterization.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Brazil. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for the primary evidence of substantial equivalence for this type of device. The "ground truth" here is the physical properties demonstrated by mechanical testing, measured by calibrated equipment.
4. Adjudication method for the test set:
- Not Applicable. As this is mechanical testing to specific ASTM standards, there is no expert adjudication process in the sense of reviewing images or clinical data. The results are quantitative measurements against predefined engineering specifications.
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 mechanical implant device, not an AI or software product. MRMC studies are for evaluating diagnostic or interpretive AI systems with human-in-the-loop.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical implant device, not an AI algorithm.
7. The type of ground truth used:
- Quantitative Mechanical Properties: The "ground truth" for this device are the quantifiable mechanical properties (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1264 and ASTM F543).
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, so there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
§ 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.