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3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions. intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.

Three Way Stop cock is composed of a Body, Rotating Handle, Luer Ports – with 2 female luer lock & 1 male luer lock with Rotating Nut. Compatible with 6% Luer combination devices. Transparent, lipid resistant body, provides easy visualization, and indicates fluid path.

The device is designed and tested as per its device specific guidance: "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".

3- Way Stop Cock is used for pressure infusion, for selective running of one or two paths intravenous lines & for measurement & also for monitoring of central venous pressure. 3- Way Stop Cock lipid-resistant is for infusing lipid-fluids & other intravenous fluids. Maximum use duration of the device is not beyond 5 days.

The provided document is a 510(k) summary for a medical device called "Three Way Stop Cock." This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance.

The acceptance criteria and study detailed in the document are related to the physical and biological safety and performance of the hardware device, not the performance of an AI/ML algorithm. There is no mention of AI or machine learning in the entire document.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving an AI device meets them from this document. The document describes:

• Acceptance Criteria for the hardware device: These are met through compliance with various ISO and ASTM standards covering physical properties (e.g., proper luer lock fitting, flow rate, blockage, leakage) and biocompatibility (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, residuals from sterilization).
• Study that proves the device meets the acceptance criteria (non-clinical testing): The document states that "testing was conducted in accordance with 'Intravascular Administration Sets Premarket Notification Submissions [510(k)]' guidance, ASTM and ISO standards." It lists several specific standards (e.g., ISO 8536-10, ISO 80369-7, ISO 10993 series, ASTM F1980-16, ASTM F 1929-15, USP ). The results "demonstrate fulfilment of requirements" and "substantial equivalence with predicate."

The request's specific points regarding AI/ML (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are not applicable to this document as it pertains to a physical medical device (a stopcock valve), not an AI/ML diagnostic or therapeutic device.

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