(7 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 know hypertension in a home care environment as an adjunct to medical management.
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 I.CD display of systolic and diastolic blood pressure readings and pulse rate, 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.
Here's a breakdown of the acceptance criteria and study information for the Nissei Model DS-1901 Digital Blood Pressure Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The primary standard referenced for performance and accuracy is the ANSI/AAMI Standard SP10-2002, Electronic or Automated Sphygmomanometers. While the document doesn't explicitly list specific numerical acceptance criteria values for this standard within the provided text, it states that the device meets the standard. The functional performance of the device is described as having the "same measurement accuracy for both blood pressure and pulse rate" as its predicate device (Nissei Model DS-181).
| Acceptance Criteria (from ANSI/AAMI SP10-2002) | Reported Device Performance (DS-1901) |
|---|---|
| Measurement Accuracy for Blood Pressure | Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181) |
| Measurement Accuracy for Pulse Rate | Meets ANSI/AAMI SP10-2002; Same measurement accuracy as predicate device (DS-181) |
| Arm Circumference Range Functionality | Evaluated for circumference of 23 to 43 cm with compensating algorithm |
| EMC/EMI Compliance | Meets IEC 60601-1-2, IEC 61000-4-x series |
| Safety and Effectiveness | Well recognized as safe and effective for intended use; Same operating principles and intended uses as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "clinical evaluation" was performed, but the number of subjects is not provided.
- Data Provenance: Not explicitly stated. Given the manufacturer (Nihon Seimitsu Sokki., Co., Ltd. from Japan) and the submission to the FDA in the US, the clinical evaluation could have been conducted in Japan, the US, or another country. The document does not specify if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For a blood pressure monitor, ground truth is typically established by trained medical professionals (e.g., physicians, nurses) using validated manual methods (like auscultatory measurements using a stethoscope) concurrently with the device being tested. No details are provided about these individuals.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable to a standalone blood pressure monitor. The device itself is designed to perform the measurement, not assist a human in interpreting diagnostic images or data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Standalone Performance: Yes, the entire clinical evaluation (e.g., against ANSI/AAMI SP10-2002) is a standalone performance assessment. The device is intended to provide blood pressure and pulse rate readings directly to the user (patient) or clinician without requiring real-time human interpretation of the measurement process itself. The accuracy metrics associated with the ANSI/AAMI standard directly reflect the standalone performance of the algorithm and hardware.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that the ground truth for blood pressure and pulse rate measurements would have been established using validated reference methods, typically auscultatory blood pressure measurements performed by trained observers, as is standard practice for clinical validation of automated sphygmomanometers per ANSI/AAMI SP10. The text does not explicitly state "auscultation" but refers to the accuracy against the standard, which relies on such methods.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. The DS-1901 is a device that includes an algorithm for measurement and compensation, but it's not a machine learning or AI model trained on a large dataset in the typical sense that would have a separate "training set" and "test set" for algorithm development. Its "algorithm" is likely fixed logic and calculation based on biomedical engineering principles, not a learnable model. While it has a "personal mode" that determines inflation value from past measurements, this is a user-specific adaptation, not a global training process.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning sense for this device. The "ground truth" for developing the underlying measurement algorithms would be based on fundamental physiological and engineering principles, validated against established reference methods during the device's design and engineering phases.
§ 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).