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The CMS Phlebotomy Bag Sets are described as devices intended to control the collection and disposal of blood, from a peripheral vein and into a container( bag) for safe removal and disposal.

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The provided text is a 510(k) premarket notification letter from the FDA regarding CardioMed (CMS) Phlebotomy Bag Sets. This type of document is a regulatory approval letter based on substantial equivalence to a predicate device, not a study report detailing acceptance criteria and device performance evaluation.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance results, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

This letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It does not elaborate on the specific performance data or studies that led to this determination beyond the statement of equivalence.

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CMS Dual Floating Dialysis Catheters are indicated for use in attaining vascular access sites for Hemodialysis and Apheresis treatments. The device is attended to be inserted into the internal jugular vein of an adult patient. Catheter greater than 40cm are intended for femoral vein insertion

Alternate insertion site is the subclavian vein as required. This catheter is indicated for duration not to exceed 12 months

CardioMed-CMS 14F Dual Floating Dialysis Catheters

I am sorry, but the provided text from the FDA document (K042672) describes a traditional medical device submission for a "CardioMed-CMS 14F Dual Floating Dialysis Catheters," not an AI/ML-driven device. As such, it does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, or AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies that would be relevant for an AI/ML device.

The document is a 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. It focuses on regulatory aspects such as the device's classification, regulation number, product code, and general controls provisions of the Act, along with its indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets criteria for an AI/ML device based on this input.

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CMS Noncor Infusion Set(s) with or without Injection Site are designed for easy insertion into vascular access devices for safe administration of continuous and/or bolus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include macrobore or microbore tubing with or without injection site.

CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site

This document is a 510(k) clearance letter from the FDA for a medical device called "CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site."

Unfortunately, this document does not contain the requested information regarding acceptance criteria, device performance studies, ground truth establishment, or sample sizes.

Here's why:

• 510(k) Clearance: A 510(k) letter signifies that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
• Focus of the Document: This specific document focuses on:
  • Confirming the FDA's review and determination of substantial equivalence.
  • Listing the regulation numbers and names for the device.
  • Outlining the general controls and regulations the manufacturer must comply with.
  • Stating the intended use of the device.

To fulfill your request, you would typically need to refer to a detailed study report, a design verification and validation document, or a performance testing summary submitted as part of the 510(k) application. These documents would contain the technical data, test protocols, acceptance criteria, and results.

Since this information is not available in the provided text, I cannot generate the table or answer the specific questions about the study design.

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