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The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.

The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.

The Aneroid Sphygmomanometer is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of an aneroid qauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff.

The Single Patient Use Aneroid Sphygmomanometer is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The proposed device is OTC, non-invasive, non-automated, and non-sterile. The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff.

Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA. The proposed device is Over-The-Counter use, non-sterile, reusable device.

This device is an Aneroid Sphygmomanometer. The provided text describes the performance testing conducted to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.

Here's an analysis of the acceptance criteria and study based on the provided text:

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

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

The text does not explicitly state the sample size used for the performance testing.
The data provenance (country of origin, retrospective/prospective) is also not explicitly stated. The manufacturer is Cardicare Company, Ltd. in China, so it's reasonable to infer the testing likely occurred there unless otherwise specified.

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 information is not provided in the document. For aneroid sphygmomanometers, the "ground truth" for accuracy is typically a reference standard manometer, not expert human assessment in the same way it would be for image interpretation. The performance testing references ISO 81060-1, which outlines specific test methods for non-automated sphygmomanometers.

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

This information is not provided in the document and is generally not applicable to the performance testing of an aneroid sphygmomanometer against a technical standard like ISO 81060-1.

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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for an aneroid sphygmomanometer.

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

This device is a manual, non-automated aneroid sphygmomanometer. It does not involve an algorithm or AI. Its performance is inherent to its mechanical design and is evaluated in a "standalone" mechanical sense by conforming to relevant standards (ISO 81060-1).

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

The ground truth for the performance testing (accuracy) would be a calibrated reference standard for pressure measurement, as guided by the ISO 81060-1 standard.

8. The sample size for the training set

This information is not applicable. Aneroid sphygmomanometers are mechanical devices and do not involve "training sets" in the context of machine learning.

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

This information is not applicable, as there is no training set for this type of device.

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