Search Results

The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a sample of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile.

The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.

Pump Segment Rinse Lines & T-Connectors
Pump segment rinse line w/ slip-on connector (Our Catalog No. PS100R)
Pump segment rinse line w/ luer-lock connector (Our Catalog No. PS100B)

T-connector, short, w/ slip-on connector (Our Catalog No. ST100R)
T-connector, short, w/ luer-lock connector (Our Catalog No. ST100B)
T-connector, long, w/ slip-on connector (Our Catalog No. LT100R)
T-connector, long, w/ luer-lock connector (Our Catalog No. LT100B)

The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector.

The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.

The luer-lock, screw-on connector securely screws on to the "male" end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frotion seal that prevents any fluids from leaking out of the dia

The provided text is a 510(k) premarket notification letter from the FDA to DaySpring Medical, Inc. regarding their Pump Segment Rinse Lines and T-Connectors. This document does not contain any information about acceptance criteria or a study proving device performance as it relates to software or AI.

The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, not on specific performance studies or acceptance criteria for a device that would typically involve AI or software components.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to a medical device that appears to be physical components (rinse lines and T-connectors) used in dialyzer reprocessing, without any mention of AI or software performance.

Ask a specific question about this device