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The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The models MS-200, MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method.

Aneroid Type Blood Pressure Kit, models MS-200D and MS-200M are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb.

The proposed device has three models, MS-200/MS-200D/MS-200M. The three models have same intended use, same design and measuring principle, same measuring range and same main components. The only differences among the three models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.

The provided text is a 510(k) summary for the "Aneroid Type Blood Pressure Kit" (models MS-200, MS-200D, MS-200M). This type of device is a traditional medical instrument and not an AI-powered diagnostic tool, therefore many of the questions related to AI device performance are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document explicitly states: "The proposed device have performed test complying with ISO 81060-1:2007." and "Results of testing were acceptable." This indicates that the device met the acceptance criteria defined by these standards.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set or the data provenance for the non-clinical testing. It only mentions "Non-clinical testing included biocompatibility and bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a manual aneroid sphygmomanometer, not an AI system or a diagnostic device requiring expert interpretation for ground truth. The accuracy is assessed on pressure measurements against a standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the type of device and testing described. Adjudication methods are typically used for establishing ground truth in image analysis or diagnostic studies, not for the performance of a mechanical blood pressure monitor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is not an AI system. It is a manual blood pressure kit. No MRMC study was mentioned or required.

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

This is not applicable as the device is not an AI algorithm. It is a manual blood pressure kit and inherently involves a human-in-the-loop (medical professional or home user) for operation and reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the accuracy testing, the "ground truth" would be established by reference standard equipment capable of precisely measuring pressure. The document refers to compliance with ISO 81060-1, which provides specific protocols for accuracy testing of non-invasive sphygmomanometers. This standard dictates the methods for determining the accuracy of the device against a known pressure.

8. The sample size for the training set

This is not applicable as the device is not an AI system that requires a training set.

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

This is not applicable as the device is not an AI system that requires a training set.

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