(115 days)
The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The manufacturer tested the TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 for performance against the AAMI / ANSI SP10:2002 standard.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance & Clinical Test | AAMI / ANSI SP10:2002 standard | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the performance and clinical test, nor does it provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The devices are blood pressure monitors and do not involve AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This does not apply as the device is a sphygmomanometer, which is a hardware medical device for blood pressure measurement, not an algorithm. The "standing alone" performance would refer to the device's accuracy in measuring blood pressure against a reference method. The document states a clinical test was performed to AAMI/ANSI SP10:2002, which is a standard for automated sphygmomanometers, implying standalone performance was evaluated.
7. The type of ground truth used
For blood pressure monitors, the ground truth for clinical accuracy testing (such as that described by AAMI/ANSI SP10:2002) is typically established by simultaneous measurements using a clinically validated reference method (often a mercury sphygmomanometer or another auscultatory method performed by trained observers). The document does not explicitly state the specific ground truth method used, but compliance with AAMI/ANSI SP10:2002 implies such a method was utilized.
8. The sample size for the training set
This information is not applicable as the devices are hardware medical devices for blood pressure measurement and are not described as using machine learning models that require a training set in the context of this 510(k) summary.
9. How the ground truth for the training set was established
This information is not applicable (see point 8).
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).