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• 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.

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.

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• 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.

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.

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