(55 days)
The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, hone lengthening/shortening, prophylactic nailing of impending fractures and fusions.
This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.
The provided text describes a 510(k) submission for a medical device called the "G/K Locking Nail System," an intramedullary rod. This document is a regulatory submission for market clearance, which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with detailed acceptance criteria and performance metrics as one might find for a novel or high-risk device.
Based on the provided text, there is no information to complete the requested sections regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
Here's why and what can be inferred:
- Substantial Equivalence: The core of a 510(k) submission like this is to show that the new device has the same intended use, materials, designs, and operational principles as existing, legally marketed predicate devices. This means that extensive new clinical studies with specific performance acceptance criteria are often not required. Instead, the focus is on demonstrating that the new device is as safe and effective as the predicate devices.
- Lack of Performance Data: The 510(k) summary and the FDA letter explicitly state that the device's substantial equivalence is based on its similarity to "Synthes' Universal Femoral Nail and Unreamed Tibial Nail and Orthofix's Tibial Nailing and Femoral Nailing Systems." There is no mention of specific performance data, studies, or clinical trials conducted for this specific device to establish new acceptance criteria.
- Device Type: Intramedullary rods are mechanical devices. Their performance is generally assessed through engineering tests (e.g., strength, fatigue, biocompatibility) and comparison to the predicate device's specifications, rather than through studies involving expert reads or ground truth derived from pathology in the way an AI diagnostic device would be.
Therefore, since the document describes a 510(k) clearance based on substantial equivalence to predicate devices, there are no acceptance criteria or detailed study results of the type requested for clinical performance evaluation.
If this were an AI/ML-driven device or a device requiring new clinical performance studies, then the requested information would be prominently featured. Since it's not, the sections below cannot be filled from the provided text.
1. A table of acceptance criteria and the reported device performance
- No information available in the provided text. The 510(k) submission for this mechanical device focuses on substantial equivalence to predicate devices, not on meeting new quantitative performance acceptance criteria through a specific study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information available in the provided text. No test set or clinical study data is described for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is an intramedullary rod, not a diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 orthopedic implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as it relates to diagnostic performance or AI evaluation is not relevant for this mechanical device. Device performance would be assessed through engineering and biocompatibility testing, potentially compared to predicate device specifications.
8. The sample size for the training set
- Not applicable. This is a mechanical orthopedic implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical orthopedic implant, not a machine learning model.
§ 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.