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SASTM hCG Urine Controls are intended to be used to monitor the performance and accuracy of SASTM pregnancy test kits. These controls are for professional use only.

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This is a 510(k) clearance letter from the FDA for a device called "SASTM hCG Urine Controls." This type of document does not contain the information requested regarding acceptance criteria or a study proving device performance because it is a regulatory clearance, not a technical performance report.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a novel study demonstrating its performance against specific acceptance criteria. The FDA's role here is to confirm that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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