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For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion

This document is a 510(k) summary for the PROTOS® 100ml and 150ml Burette Infusion Sets. It's a regulatory letter from the FDA to Globe Enterprises, Incorporated, dated December 17, 1997, indicating that the device has been found substantially equivalent to predicate devices.

This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory clearance letter, not a scientific study report. Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• 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

The document primarily focuses on:

• The FDA's determination of substantial equivalence (K972839) for the PROTOS® Burette Infusion Set.
• The regulatory classification (Class II, Product Code FPA).
• Indications for Use: "For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner."
• General regulatory requirements applicable to the device.

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For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

PROTOS® I.V. Administration Set (15 Drops/ML) and (60 Drops/ML)

The provided text is a 510(k) premarket notification letter from the FDA regarding an IV administration set. This type of document does not typically contain the detailed acceptance criteria and study results that would be used to prove a device meets those criteria.

510(k) clearances are primarily based on demonstrating substantial equivalence to an already legally marketed predicate device, rather than detailed performance studies proving specific acceptance criteria. The letter confirms that Globe Enterprises, Incorporated's PROTOS® I.V. Administration Set is substantially equivalent to existing devices.

Therefore, for your request, I must state that the provided document does not contain the information necessary to fulfill items 1 through 9.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory approval, not a performance report.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not applicable. This device is not an algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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For the delivery of blood or blood related solutions by or on the order of a physician or other licensed practitioner.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device performance as requested. The text consists of an FDA 510(k) clearance letter for the "Protos Blood Transfusion Set" and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not detail performance studies, acceptance criteria, or any of the specific points you've asked for regarding AI/algorithm performance.

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