(137 days)
The Ideal™ Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union).
The Ideal™ Intramedullary Nail System is intended to provide temporary fracture and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union). It consists of intramedullary nail. locking screw and end cap. 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 locking screw passes through the holes at the proximal and distal sections of intramedullary nail for preventing rotation and axial compression. The end cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads. All implants of intramedullary nail system are manufactured from Ti-6A1-4V allov that meets the requirements of ASTM F-136. The materials are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
The provided text describes a 510(k) summary for the Ideal™ Intramedullary Nail System, a medical device intended for temporary fracture fixation and stabilization of the tibia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Test Conducted) |
|---|---|
| ASTM F1264-03 (Reapproved 2007) - Static bending requirements | Static bending test |
| ASTM F1264-03 (Reapproved 2007) - Static torsion requirements | Static torsion test |
| ASTM F1264-03 (Reapproved 2007) - Dynamic bending requirements | Dynamic bending test |
| ASTM F 543-07 - Pullout strength requirements | Pull out test |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size (number of nails or screws) used for each of the non-clinical tests.
- Data Provenance: The tests were conducted by the manufacturer, Jiangsu Ideal Medical Science & Technology Co., Ltd., which is based in China. The data would therefore be considered prospective non-clinical test data.
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 non-clinical bench testing study, not a clinical study involving human or animal subjects that would require expert-established ground truth for a test set. The "ground truth" here is adherence to specified ASTM standards.
4. Adjudication method for the test set:
- Not Applicable. As a non-clinical bench testing study, there is no need for an adjudication method as would be used in a clinical trial to resolve discrepancies in expert interpretation. The performance is objectively measured against predefined engineering standards.
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. This document pertains to a physical medical implant (an intramedullary nail system), not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. The tests performed are standalone in the sense that they assess the physical properties of the device itself (mechanical strength, resistance to forces) without human-in-the-loop interaction in the testing process. However, this question typically refers to the performance of an AI algorithm operating independently, which is not applicable here.
7. The type of ground truth used:
- The ground truth for this device's performance is based on established engineering standards and specifications, specifically ASTM (American Society for Testing and Materials) standards. The device's performance is compared against the requirements outlined in ASTM F1264-03 (Reapproved 2007) for intramedullary fixation devices and ASTM F 543-07 for metallic medical bone screws.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As this device does not utilize a training set, the establishment of ground truth for such a set is not relevant.
§ 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.