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510(k) Data Aggregation
(286 days)
AOS UNIVERSAL CONECTING GUIDE TUBE
The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.
Alpha-Omega Services (AOS) Universal Connecting Guide Tube is used to connect any Alpha-Omega applicator accessory with Luer Lock fittings to a High Dose Rate (HDR) Afterloader. The Alpha-Omega universal Connecting Guide Tube is supplied in the nominal length of 100cm. The distal end is a female luer lock, which is used to connect to the male end of the Luer Lock applicator/accessory or to the Extension Adaptor and Needle combination, providing an un obstructed pathway for the source wire or cable from the Afterloader to the tip of the applicator/accessory.
This 510(k) summary describes a device-to-device comparison, not a study involving human-AI interaction or diagnostic performance. Therefore, many of the requested categories related to clinical studies, expert review, and AI performance metrics are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|
| - Design | Same design |
| - Material Construction | Constructed of the same materials |
| - Single Use | Single Use Only |
| - Non-sterile (for predicate) | Sterile (new device is sterile) |
Explanation: The "acceptance criteria" here refers to the characteristics of the predicate device that the new device must meet or be equivalent to. The "reported device performance" indicates how the new device compares to these characteristics. The key difference noted is sterilization.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This was not a study involving a "test set" in the context of clinical data or AI performance. This was a direct comparison of device characteristics for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of medical image analysis or AI, is not relevant here as this is a comparison of physical device characteristics. The assessment of substantial equivalence was performed by the FDA.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication in the context of clinical or AI performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a submission for substantial equivalence of a medical device, not a comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical instrument (guide tube), not an algorithm or AI software. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the established characteristics and safe/effective use of the predicate device (AOS Universal Connecting Guide Tube, K964910). The new device is deemed substantially equivalent if it shares these fundamental characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no training set involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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