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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or pentoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

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The provided document is a 510(k) clearance letter from the FDA for the "Belmont Hyperthermia Pump", not an AI/ML device. Therefore, the questions related to acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data are not applicable to this document. These questions are typically relevant for AI/ML device submissions where performance is measured against ground truth and compared to human readers.

This document only states the "Indications for Use" for the device, which is: "The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician."

No performance data, acceptance criteria, or study details are provided in this regulatory letter.

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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Belmont Hyperthermia Pump). This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested. It primarily focuses on the regulatory clearance of the device based on its substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

Therefore, I cannot extract the information required to populate your table and answer your questions.

Ask a specific question about this device