(257 days)
- Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union.
The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail.
The provided document describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Metallic Intramedullary Nail System" to a predicate device. However, this is a premarket notification for a medical device (intramedullary nail), which is a physical implant, not an AI/ML-powered device or diagnostic tool. Therefore, many of the requested categories (like MRMC study, human reader improvement with AI assistance, ground truth establishment for AI models, training set details) are not applicable to this type of device and study.
The study performed is a non-clinical mechanical performance test, comparing the device to a predicate device based on engineering standards, not a clinical study involving patients or expert interpretation of diagnostic output.
Here's an analysis based on the information available, addressing the applicable categories:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The acceptance criterion for this device is "Substantial Equivalence" to the predicate device, specifically regarding its mechanical performance and other characteristics. The device performance is demonstrated through non-clinical testing.
| Acceptance Criteria Category/Characteristic | Predicate Device Performance / Characteristic | Proposed Device Performance / Characteristic | Conclusion (Meets/Does Not Meet) |
|---|---|---|---|
| Product Code | HSB | HSB | Meets (Same) |
| Regulation No. | 888.3020 | 888.3020 | Meets (Same) |
| Class | II | II | Meets (Same) |
| Classification Name | Rod, Fixation, Intramedullary And Accessories | Rod, Fixation, Intramedullary And Accessories | Meets (Same) |
| Intended Use | Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union | Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union | Meets (Same) |
| Configuration | Nail, Screw and End cap | Nail, Screw and End cap | Meets (Same) |
| Screw Feature | Single cortical fixation achieved by proximal threaded locking screw. | Single cortical fixation achieved by proximal threaded locking screw. | Meets (Same) |
| Sterile | Supplied non-sterile, to be sterilized prior to use (SAL 1x10^-6) | Supplied non-sterile, to be sterilized prior to use (SAL 1x10^-6) | Meets (Same) |
| Single Use | Yes | Yes | Meets (Same) |
| Labeling | Conforms to 21 CFR 801 | Conforms to 21 CFR 801 | Meets (Same) |
| Mechanical Specification (Nail & Screw) | Tested per ASTM F1264:2003 R2007 (Specific quantitative results for bending strength, fatigue life are not provided in this summary, but the method is the criterion). | Tested per ASTM F1264:2003 R2007. The summary states: "the mechanical test demonstrated the results of both devices are very similar." | Meets (Similar results based on standard test) |
| Material Specification | Titanium Alloy (Ti-6Al-4V ELI); Conforms to ASTM F136 Standard | Titanium Alloy (Ti-6Al-4V ELI); Conforms to ASTM F136 Standard | Meets (Same) |
| Dimensions (Physical Specification) | Ranges provided for Nail (diameter, length), Screw (diameter, length), End Cap (diameter, length) | Ranges provided for Nail (diameter, length), Screw (diameter, length), End Cap (diameter, length) Note: Dimensions are different, but the mechanical test results are reported as similar. | Meets (Differences in dimensions are acceptable if mechanical performance is similar) |
Study Information (Applicable to Non-Clinical Mechanical Testing):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications". It does not specify a "sample size" in terms of number of devices tested, but rather that the device was tested per ASTM F 1264-03(Reapproved 2007). This standard dictates the test methods for intramedullary fixation devices, including specimen preparation and required number of specimens for various tests (e.g., static bending, fatigue). The provenance of the data is from the manufacturer, Tianjin Walkman Biomaterial Co., Ltd, in China, as part of their 510(k) submission. These are prospective non-clinical tests.
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. Ground truth in this context refers to the physical properties and mechanical performance of the materials and devices as measured using standardized laboratory tests, not expert interpretation of images or clinical outcomes. The "ground truth" is established by the specifications in ASTM F1264 and ASTM F136.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant for objective mechanical testing.
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 non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device with an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1264-03(Reapproved 2007)) and material specifications (ASTM F136 Standard for Titanium Alloy). The device's performance is compared against these engineering standards and to the predicate device's performance under these same standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no "training set." The performance of the predicate device serves as a benchmark for comparison, and both devices are evaluated against established engineering standards.
§ 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.