(228 days)
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta and other pediatric bone diseases without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.
The Fassier-Duval Telescopic IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The naliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Telescopic IM System can be attached to bony structures without disrupting the bone growth plates. The device is sold both sterile and Non sterile.
This document describes the Fassier-Duval Telescopic IM System, an intramedullary fixation rod. The 510(k) submission, K241983, primarily focuses on updating the intended use of the device to include other pediatric bone diseases beyond Osteogenesis Imperfecta and providing MR safety labeling information. The device itself is substantially equivalent to previously cleared predicate devices, with no design changes.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on the concept of substantial equivalence to predicate devices and adherence to recognized standards for MR safety. The "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as its predicates and is MR Conditional according to established ASTM standards.
| Acceptance Criteria (Implicit) | Reported Device Performance and Supporting Evidence |
|---|---|
| Functional Equivalence to Predicate Devices: | The device is stated to have no differences from the primary predicate (Fassier-Duval Telescopic IM System, K211292) in terms of system components, dimensions, design features, cross-sectional geometry, and sterilization. |
The intended uses are similar, all for deformity correction and fracture fixation.
The subject device also shares technological characteristics (design, materials, principle of operation) with its predicates. The only difference is the expanded intended use to include "other pediatric bone diseases" which is covered by the predicate Simple Locking Intramedullary (SLIM) System (K192710).
The submission states, "The information provided above supports that the Fassier-Duval Telescopic IM System is as safe and effective as the predicate devices." |
| Safety and Effectiveness for Expanded Intended Use (Other Pediatric Bone Diseases): | The submission states: "The successful usage of the subject device pertaining to [the new intended use] is supported by the already available clinical literature. The clinical literature data provided in this submission support the amended intended use and do not raise different questions for safety and effectiveness." |
| MR Safety (MR Conditional): The device should be safe for use in an MR environment and meet relevant safety standards. | The implants were evaluated in an MR environment and determined to be MR Conditional. This evaluation was based on FDA-recognized standards:
- ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants.
- ASTM F2052-14: Measurement of Magnetically Induced Displacement Force.
- ASTM F2213-06: Measurement of Magnetically Induced Torque.
- ASTM F2182-11a: Measurement of Radio Frequency Induced Heating. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not mention a specific test set or sample size in the traditional sense of a clinical trial or a formal device performance study with a 'test set' of patients or data.
For the MR safety evaluation, the "test set" would be the physical Fassier-Duval Telescopic IM System implants themselves, tested under specific MR conditions defined by the ASTM standards. The provenance of these tests is implied to be within controlled laboratory environments according to the specified ASTM test methods. No patient data is involved in this part.
For the expanded intended use, the submission refers to "already available clinical literature." This suggests a retrospective review of published studies involving similar devices or the predicate device in similar patient populations. No specific sample size or direct patient data provenance (e.g., country of origin) for a new test set is provided in this document.
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)
Given the nature of the submission (substantial equivalence and MR safety testing), there is no mention of experts establishing a ground truth for a test set in the context of diagnostic or clinical accuracy. The "ground truth" for MR safety is established by the rigorous parameters and results of the ASTM standard tests. For the expanded intended use, the "ground truth" of safety and effectiveness for "other pediatric bone diseases" is inferred from the collective body of existing clinical literature, which would have involved the consensus of medical professionals who authored those studies. Specific details on the number or qualifications of these authors/experts are not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there is no formal clinical test set or diagnostic study described, there is no adjudication method mentioned. The MR safety testing follows standardized protocols, and the interpretation of results is based on these engineering standards rather than expert adjudication of clinical outcomes. The clinical literature review for the expanded intended use would have encompassed existing conclusions from individual studies, but no new adjudication process is described here.
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
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is it applicable. This device is an intramedullary fixation rod, a physical implant, not an AI-assisted diagnostic tool. Therefore, direct comparison of human reader performance with or without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For MR Safety: The ground truth is based on the objective measurements and criteria defined by the ASTM international standards (e.g., specific deflection, torque, temperature rise limits). These are engineering standards designed to ensure material and device safety in an MR environment.
- For Expanded Intended Use: The ground truth relies on outcomes data and expert consensus reported in "already available clinical literature" concerning the use of similar telescopic intramedullary systems in patients with various pediatric bone diseases. This is a literature-based justification rather than a directly generated new ground truth.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device as it is not an AI/ML algorithm or a diagnostic tool that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.