(90 days)
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.
The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.
The provided document is a 510(k) summary for the MedAmicus Axia RSN™ catheter introducer. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Here's why and what information is missing based on your request:
Key Takeaway: The document explicitly states: "No new testing was performed for the device as the only change being made is to the Indications for Use. All testing previously summarized in K011085 remains applicable." This means the current submission (K020563) relies on studies conducted for a previous device (K011085) for its safety and effectiveness claims.
Therefore, for your specific questions, the answers are largely "Not applicable" or "Not provided in this document."
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance
- Not provided in this document. The document does not define specific acceptance criteria for performance metrics (e.g., probability of needle stick injury, force required for retraction, number of successful retractions). It focuses on the change in "Indications for Use" for an existing device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in this document. Since no new testing was performed, this information would have been part of the previous 510(k) submission (K011085), which is not included here.
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/Not provided. The device is a physical medical device, not an AI or diagnostic application that typically relies on expert ground truth for evaluating performance. Its "performance" would likely be based on engineering benchmarks, user studies for safety features, and mechanical reliability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is relevant for image-based diagnostic AI, not for a physical medical device like a catheter introducer.
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 study type is specific to AI-assisted diagnostic tools. The MedAmicus Axia RSN™ is a physical medical device designed to reduce needle stick injuries, not to assist in interpreting diagnostic images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable directly. For a safety needle, "ground truth" would likely relate to objective measurements of safety features (e.g., successful retraction rate, force to retract, accidental stick rate in simulated use). The document does not detail these.
8. The sample size for the training set
- Not applicable. This refers to AI model training data.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI model training data.
In summary: The provided document is a regulatory submission for a change in "Indications for Use" for an already cleared device. It explicitly states that no new testing was performed for this submission. All performance and safety data would be found in the referenced predicate device's 510(k) (K011085). Therefore, the specific details you requested regarding acceptance criteria and performance studies are not present in this document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).