(145 days)
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.
The provided text is a 510(k) summary for the NIHON SEIMITSU SOKKI CO., LTD. Model DS-1901 Digital Blood Pressure Monitor. This document explicitly states that there is no difference in intended use and technology characteristics between the subject device and the predicate device (K050697). The reason for the 510(k) submission is to include detection and display of irregular pulse rhythm in the Indications for Use Statement, a feature already present in the predicate device.
Therefore, the study conducted for this specific 510(k) submission (K071384) primarily relies on the equivalency to the predicate device, K050697. The document does not describe a new, independent study with specific acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies for the DS-1901 device itself. Instead, it refers to the performance of the predicate device.
Based on the information provided, here's a best effort to address the prompt, acknowledging the limitations of the document for a direct answer to all questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate) | Reported Device Performance (from Predicate) |
|---|---|
| Pressure: +/- 3 mmHg | Pressure: +/- 3 mmHg |
| Pulse rate: +/- 5% or reading | Pulse rate: +/- 5% or reading |
2. Sample size used for the test set and the data provenance
The document for K071384 does not specify a distinct test set or its sample size. It states that the subject device (DS-1901) is equivalent to the predicate device (K050697). Therefore, the performance data is inferred from the predicate device. The provenance of the data for the predicate device is not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving experts to establish ground truth for this submission, as it relies on equivalency to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study with an adjudication method.
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
Not applicable. This device is a digital blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone automatic blood pressure monitor. Its performance, as stated through equivalency to the predicate, is the "algorithm only" performance for blood pressure and pulse rate measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood pressure monitors, the "ground truth" (or reference standard) for accuracy is typically a manually performed auscultatory measurement using a mercury sphygmomanometer or another validated reference device, conducted by trained personnel. This information is not explicitly stated in the provided document but is the common standard for such devices.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm development for this specific submission, as it relies on equivalency to a predicate device.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or how its ground truth would be established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is an equivalency study to a previously cleared predicate device, Model 1901 Digital Blood Pressure Monitor (K050697). The 510(k) submission for the DS-1901 explicitly states: "There is not a difference of intended use and technology characteristic between the subject device and any predicate device (K050697)." The reason for the submission was to formally add "detection and display of irregular pulse rhythm" to the Indications for Use, a feature already present in the predicate. The performance specifications (accuracy of pressure and pulse rate measurement) are therefore directly inherited from the predicate device, which would have undergone its own validation testing to demonstrate these accuracies against a reference standard.
§ 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).