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510(k) Data Aggregation
(210 days)
Medical Components Inc. (Medcomp)
Luer lock plug for capping male or female luer tapers for hemodialysis catheters.
The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.
The provided document is a 510(k) summary for a medical device called "End Cap". It details the device's description, indications for use, comparison to a predicate device, and performance data for demonstrating substantial equivalence.
However, the questions you've asked are specifically about the acceptance criteria and study proving the device meets acceptance criteria for an AI/ML-enabled medical device. The provided document is for a physical medical device (luer lock plug) and does not involve AI or machine learning. Therefore, the questions related to AI/ML device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable to the content of this document.
The document discusses performance testing (bench testing) to ensure the physical device meets relevant standards, but this is different from the type of performance evaluation required for an AI/ML diagnostic or predictive device.
Here's how I can address the applicable parts of your request based on the provided document, interpreting "acceptance criteria" in the context of a physical device's regulatory submission:
The "acceptance criteria" for this device's submission revolves around demonstrating substantial equivalence to a legally marketed predicate device by meeting recognized consensual standards for physical device performance and biocompatibility.
1. A table of acceptance criteria and the reported device performance
For a physical device like the End Cap, acceptance criteria are typically defined by compliance with recognized international standards (ISO standards in this case) and demonstrating safe and effective performance. The "reported device performance" is essentially that the device passed these tests, confirming its compliance.
| Acceptance Criteria (Defined by Standard) | Reported Device Performance (as stated in submission) |
|---|---|
| ISO 594-1:1986 | Passed (Medcomp® End Cap met requirements for Gauging, Liquid Leakage, Air Leakage, Stress Cracking) |
| * Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements | |
| ISO 594-2:1998 | Passed (Medcomp® End Cap met requirements for Separation Force, Liquid Leakage, Air Leakage, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking) |
| * Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings | |
| ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process | Passed (Met biocompatibility requirements for an external communicating device with circulating blood contact for a limited duration ( |
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