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The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm42 cm or 22cm48cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor (Model:SP10A).

The provided text is an FDA 510(k) clearance letter for an Upper Arm Blood Pressure Monitor, Model SP10A. It primarily addresses the regulatory approval process and includes the device's indications for use.

Crucially, this document does NOT contain information about acceptance criteria, specific study designs (like sample sizes, data provenance, expert qualifications, or multi-reader studies), or the detailed performance metrics of the device against such criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present in the document.
• Sample sizes used for the test set and data provenance: Not detailed.
• Number of experts used to establish ground truth and qualifications: Not detailed.
• Adjudication method: Not detailed.
• MRMC comparative effectiveness study details: Not mentioned. This type of study is more common for AI/imaging devices, not a blood pressure monitor.
• Standalone (algorithm only) performance: Not applicable for this device.
• Type of ground truth used: Not detailed.
• Sample size for the training set: Not detailed.
• How ground truth for the training set was established: Not detailed.

For these details, one would typically need to refer to the full 510(k) submission or supporting clinical validation reports, which are not included in this FDA clearance letter. The letter confirms clearance based on substantial equivalence, but not the detailed study results that led to that determination.

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The Infrared thermometer is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear canal or by the center of forehead(non-contact type) for people of all ages.

Not Found

The provided text concerns the FDA 510(k) clearance for an "Infrared thermometer" (K221211). It does not describe:

• Acceptance criteria for an AI/ML device. This document is for a physical medical device (an infrared thermometer), not a software or AI-driven diagnostic tool.
• A study proving the device meets acceptance criteria. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance, rather than detailing a specific performance study against defined acceptance criteria.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a device or study.

The request specifically asks for information related to AI/ML device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance). This information is entirely absent for a simple infrared thermometer.

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The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor, Model SP10A

The provided text is a U.S. FDA 510(k) clearance letter for an "Upper Arm Blood Pressure Monitor, Model SP10A." It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or training set information.

Instead, the document primarily focuses on:

• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: References to applicable regulations (e.g., 21 CFR 870.1130 for noninvasive blood pressure measurement systems), general controls, and other requirements.
• Indications for Use: Describes the intended use of the device for measuring diastolic and systolic blood pressure and pulse rate in adults using an oscillometric technique, for use in hospital or home environments.
• Type of Use: Specifies that it is intended for Over-The-Counter Use.

To answer your request, a different type of document, such as a summary of safety and effectiveness, clinical study report, or specific test results, would be needed. The current document does not provide the detailed performance and study information you're asking for.

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