Search Results

The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

The Radian MIS Bunion System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA regarding "The Radian MIS Bunion System". This document focuses on the regulatory clearance of a medical device (a bone fixation system) based on its substantial equivalence to previously cleared predicate devices.

The document does not describe any acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance.

Instead, it details the physical and mechanical performance testing of the Radian MIS Bunion System hardware (plate and screws), which are orthopedic implants, to demonstrate their safety and efficacy for their intended use.

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study, as no such study is mentioned or relevant to this specific FDA clearance.

Here's a breakdown of what is available regarding the device (not an AI algorithm):

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified for the mechanical tests, but these would typically involve a set number of physical devices/components for destructive and non-destructive testing.
• Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based mechanical 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 performance of medical hardware, not interpretation of data by human experts for diagnostic purposes. These properties are established by standardized testing methods (e.g., ASTM F382) and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used for resolving disagreements in expert interpretations or labels, which is not relevant to mechanical testing of hardware.

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, not specified and not applicable. This type of study is for evaluating diagnostic performance, typically of AI tools, and is not mentioned for this orthopedic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No, not applicable. This document is about a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable in the AI/ML sense. For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and constructs under tested conditions as measured by calibrated equipment and compared against established engineering standards (e.g., ASTM F382) and the mechanical performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm discussed that would require a training set.

9. How the ground truth for the training set was established:

• Not applicable. There is no AI/ML algorithm discussed.

Summary of the Study Discussed (Mechanical Testing):

The "study" described in the 510(k) summary is a set of non-clinical mechanical tests performed on the Radian MIS Bunion System.

• Tests performed:
  • Static bending (per ASTM F382)
  • Dynamic bending (per ASTM F382)
  • Engineering analysis to evaluate screw mechanical strength
• Purpose: To demonstrate that the Radian MIS Bunion System is "substantially equivalent" to predicate devices in terms of safety and efficacy, particularly regarding its mechanical performance.
• Conclusion: The tests indicate that the device does not raise new issues of safety or efficacy and is substantially equivalent to the predicate devices.

Ask a specific question about this device