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The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure.

The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid sphygmomanometer to measure pressure, and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: 1. Adjustable D-ring Cuff (Adult Size) 2. Stethoscope (Attaches to the cuff) 3. Non-stop rotary pin, 300 mmHg gauge 4. Instruction booklet and record 4. Carrying case The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor the pressure of flowing blood that is exerted against the arteries at highest (systolic or contraction) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pulse of the brachial artery. After inflation of the cuff, the user does auditory monitoring with the stethoscope to evaluate systolic and diastolic pressure. The two values are usually recorded as a ratio of the two measurements: systolic over diastolic.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AS101 Blood Pressure Cuff:

It's important to note that this 510(k) summary is for an Aneroid Sphygmomanometer, a non-automated, mechanical device. Therefore, the questions related to AI, algorithms, and multi-reader multi-case studies are not applicable.

Acceptance Criteria and Device Performance Study for K060871

1. A table of acceptance criteria and the reported device performance

The submission states that testing was performed in accordance with AAMI/ANSI SP10: 2002 & AAMI/ANSI SP10: 2002/A1: 2003 and that the device conforms to this standard. The AAMI/ANSI SP10 standard for non-automated sphygmomanometers defines the acceptance criteria for accuracy.

Note: The specific numerical values (e.g., mean difference, standard deviation) are not provided in the summary but are implicitly met by the statement of conformity to the standard.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set. For AAMI/ANSI SP10, typically, a minimum of 85 participants (with specific blood pressure ranges covered) are required for clinical validation studies to assess performance against reference measurements.

The data provenance is not explicitly mentioned but implies a clinical study was conducted as per the AAMI/ANSI SP10 standard. The country of origin of the data is not specified. It is a prospective study, as the device performance is being validated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For an aneroid sphygmomanometer, the "ground truth" during validation according to AAMI/ANSI SP10 is established by trained observers (typically healthcare professionals) taking simultaneous measurements using a reference standard (e.g., a mercury sphygmomanometer) alongside the device under test. The standard specifies detailed training and qualification for these observers. The exact number of experts and their specific qualifications are not provided in this summary, but would adhere to the requirements of the AAMI/ANSI SP10 standard.

4. Adjudication method for the test set

The AAMI/ANSI SP10 standard outlines specific protocols for comparing the device under test to a reference standard, often involving multiple readings by trained observers to minimize measurement error. This acts as an "adjudication" in a sense by creating a robust reference. The text doesn't explicitly detail a separate adjudication method beyond adherence to the standard's methodology for comparing readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not applicable nor performed for this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers interpret medical images. The AS101 is a mechanical blood pressure cuff.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm-only) performance study was not applicable nor performed. This device is a non-automated mechanical device that requires a human operator to inflate the cuff, listen for Korotkoff sounds with a stethoscope, and read the pressure gauge. There is no "algorithm" in the modern sense.

7. The type of ground truth used

The ground truth used for this type of device (Aneroid Sphygmomanometer) is simultaneous reference measurements, typically obtained using a calibrated reference sphygmomanometer (historically mercury sphygmomanometer) by trained observers. This is essentially an expert measurement standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical device and does not involve machine learning or an "algorithm" that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for a mechanical device.

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