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For use with any I.V. set assembled on commercially available I.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or I.V. fluids.

Anti Free Flow Valve

This document is a 510(k) clearance letter from the FDA for a medical device called the "Free Flow Safety Device, Model MG 245052," also referred to as an "Anti Free Flow Valve." The letter confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is solely a regulatory clearance letter and does not include the detailed technical study information that would typically be part of a 510(k) submission's supporting data.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided input. This document only confirms that the device has received FDA clearance for marketing.

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Subcutaneous injection of Copaxone®.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Copaxone (Glatiramer Acetate for Injection) EZ-Ject from Shared Solutions." This letter primarily discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information regarding:

• Acceptance criteria: Specific performance metrics or thresholds the device needed to meet.
• A study proving the device meets acceptance criteria: There is no description of any clinical trial, bench test, or other study.
• Reported device performance: No data on accuracy, precision, reliability, or any other performance metric is provided.
• Sample size for test set or training set.
• Data provenance.
• Number or qualifications of experts.
• Adjudication method.
• MRMC comparative effectiveness study or human reader improvement.
• Standalone algorithm performance study.
• Type of ground truth used.
• How ground truth was established for training set.

The letter is a regulatory document confirming substantial equivalence, not a summary of a performance study. It states the "Indications for Use" for the device, which is "Subcutaneous injection of Copaxone®." This is a functional description, not a performance criterion.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets the acceptance criteria as this information is not present in the document. The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device but does not detail the technical performance criteria or the studies conducted to establish them.

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