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510(k) Data Aggregation
(100 days)
The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.
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The provided text is a 510(k) premarket notification acceptance letter from the FDA to Rossmax International Ltd. for their Digital Sphygmomanometer MANDAUS II. It's a regulatory document and does not contain the detailed study results or acceptance criteria and device performance table typically found in scientific publications or clinical study reports.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not describe the specific performance criteria or the study that demonstrates compliance.
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(140 days)
Wrist type non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.
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The provided text is a 510(k) clearance letter from the FDA for the Rossmax Wrist Type Blood Pressure Monitor, Models B150 and Q400. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance data.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.
The document states that the device is a "Wrist type non-invasive blood pressure system that measure systolic, diastolic, and pulse rates for adult consumers in a home environment." The FDA's determination of substantial equivalence implies that the device is expected to meet the performance standards set by its predicate device, but the specifics of those standards and the device's performance against them are not detailed in this clearance letter.
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(27 days)
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(17 days)
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