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The Access Radiology "Framewave Web" Image and Information System is indicated for the display and management of radiologic images and associated information stored and transmitted in both compressed and uncompressed form.

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This document is a 510(k) clearance letter from the FDA for a device called "Framewave™ Web" dated December 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance, details of a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for training or testing sets. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms the device's regulatory classification and permissibility to market.

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The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.

Pd-103 Radionuclide Brachytherapy Source

This is a clearance letter from the FDA for a medical device called the "Pd-103 Radionuclide Brachytherapy Source." The letter indicates that the device has been found substantially equivalent to pre-amendment devices and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is a regulatory approval letter, not a scientific study report. It states that the device is "intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions," but does not provide any data on its effectiveness or safety from specific studies.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.

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The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.

I-125 Radionuclide Brachytherapy Source Model MED3631-A

This document is a 510(k) premarket notification letter from the FDA regarding an I-125 radionuclide brachytherapy source. As such, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The letter approves the device based on substantial equivalence to a predicate device, meaning it was determined to be as safe and effective as a device already legally marketed. It does not provide data from a specific study designed to prove new acceptance criteria for this particular device.

Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation report:

1. Table of acceptance criteria and reported device performance: Not present in this document.
2. Sample size 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 for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable or present for this type of device (a brachytherapy source, not an AI diagnostic tool).
6. Standalone (algorithm only) performance: Not applicable or present.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/machine learning involved).
9. How the ground truth for the training set was established: Not applicable.

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