(241 days)
- Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union
The WASTON 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 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.
All implants of Metallic Intramedullary Nail System are manufactured from Ti-6Al-4V alloy that meets the requirements of ASTM F-136.
The proposed devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.
This document describes a 510(k) premarket notification for the "WASTON Metallic Intramedullary Nail System." It is a medical device submission, and therefore, the acceptance criteria and study data provided are related to the substantial equivalence of the proposed device to a predicate device, rather than a standalone clinical AI or diagnostic performance study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" isn't typically phrased as a specific numerical performance target, but rather as demonstrating substantial equivalence (SE) to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
The document presents a comparison between the proposed device and the predicate device (K132078) to demonstrate this substantial equivalence.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Product Code: HSB | Same |
| Regulation Number: 21 CFR 888.3020 | Same |
| Intended Use: Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union | Same |
| Configuration: Nail, Screw and End Cap | Same |
| Sterile: Supplied non-sterile, sterilized by hospital to achieve SAL 1x10-6 | Same |
| Single Use: Yes | Same |
| Material: Titanium Alloy (TI -6A1-4 V ELI) | Same |
| Physical Specification (Nail): Proximal/Distal diameter: φ10/φ8 mm, φ10/φ9 mm, φ10/φ10 mm; Length: 240~340 mm | Same |
| Physical Specification (Screw): Diameter: φ6mm; Length: 20~95 mm | Similar (Implies slight variations within acceptable limits, not explicitly stated as "same") |
| Mechanical Specification (Nail): Static bending, Dynamic bending and Static Torsional performance tested per ASTM F1264 | Same (Implies meeting the same test standards and performance levels) |
| Mechanical Specification (Screw): Dynamic bending performance tested per ASTM F1264; Driving torque and pull-out performance tested per ASTM F543 | Same (Implies meeting the same test standards and performance levels) |
| Non-clinical tests verify design specifications and SE to predicate. | Complies with ASTM F1264-03, ASTM F543-13, ASTM F136-13, ASTM F138-13, ISO 17665-1:2006 (See Section 6 of the 510(k) Summary) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical or diagnostic performance data. The "tests" mentioned are non-clinical (mechanical, material, sterilization) and are typically performed on samples of the device components (e.g., a certain number of nails, screws). The sample sizes for these non-clinical tests are not detailed in this summary. The data provenance would be from the manufacturing and testing facilities of Changzhou Waston Medical Appliance Co., Ltd. in China.
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. As stated, no clinical study or ground truth establishment based on expert review was performed or included in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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 device is a metallic intramedullary nail system for fracture fixation, not an AI or diagnostic imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" would be established by reference to international consensus standards (e.g., ASTM, ISO) for material properties and mechanical performance.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI or machine learning device.
§ 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.