(114 days)
The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician.
The Model DM-3000 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement of systolic and diastolic blood pressures and pulse rate in adult patients under the supervision of a physician. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes air pumps for automatic cuff inflation, electric valves, button controls, circuitry to detect and process minute pressure oscillations, a bar LCD to display mercury-column-like pressure flow and a segment LCD to display blood pressure and pulse rate as a digital value and operation indications such as inflation, measurement error and battery error. Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done, or manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery.
Here's an analysis of the provided text regarding the Nissei Model DM-3000 Digital Blood Pressure Monitor with respect to acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) Premarket Notification Summary for a blood pressure monitor. These summaries often focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a full, independent clinical study with detailed acceptance criteria for a novel device. As such, some of the requested information (especially regarding performance thresholds, detailed study design, and expert involvement for "AI" or "algorithm" focused criteria) is not explicitly present because the device is a medical measurement instrument, not an AI diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
For the Nissei Model DM-3000 Digital Blood Pressure Monitor, the primary performance criterion is accuracy, which is assessed against the ANSI/AAMI Standard SP10-1992. The document states that the new device has the same measurement accuracy for both blood pressure and pulse rate as its predicate device. This implies that the predicate device's performance already met the ANSI/AAMI standard, and the new device maintains that performance.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy (per ANSI/AAMI SP10-1992) | "Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard. |
| Pulse Rate Accuracy (per ANSI/AAMI SP10-1992) | "Same measurement accuracy for both blood pressure and pulse rate" as the predicate device (Nissei Model DM-3000, K993890), which was previously cleared under the same standard. |
| Electromagnetic Compatibility | Complies with IEC 60601-2, 2001 (with referenced amendments) and IEC 60601-1-2, 2001. |
Note: Specific numerical accuracy thresholds (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in this summary, but would be defined by the ANSI/AAMI SP10-1992 standard.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical evaluation" but does not specify the sample size for any test set. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that this is a 510(k) for an update to an existing device, it's likely a relatively small clinical evaluation focused on confirming the equivalence of the updated features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth during the clinical evaluation. For blood pressure monitors, ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a auscultatory method with a mercury sphygmomanometer as the reference standard, following established protocols.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method. For blood pressure monitor accuracy studies, multiple reference readings are often taken and averaged, but a formal adjudication process (like 2+1 or 3+1 for discordant readings) is not a typical requirement for establishing ground truth for simple physiological measurements like blood pressure in the same way it would be for image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images with and without AI assistance, and it's not applicable to a non-invasive blood pressure monitor.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the device's automatic measurement capabilities was done. The description indicates:
- "Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done..."
- The clinical performance and accuracy testing was conducted against the ANSI/AAMI SP10-1992 standard, which is designed to evaluate the standalone performance of automated sphygmomanometers.
7. The Type of Ground Truth Used
For blood pressure monitors, the ground truth is typically established by expert reference measurements, specifically auscultatory readings obtained by trained clinicians using a calibrated reference device (often a mercury sphygmomanometer) in parallel with the device under test. This is the standard method specified in the ANSI/AAMI SP10 standard.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is a conventional blood pressure monitor, not an AI/ML-based algorithm that requires a "training set" in the machine learning sense. The device uses established oscillometric principles for measurement, validated through engineering design and a clinical evaluation.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. For traditional medical devices like blood pressure monitors, the "ground truth" concept applies to the validation or test set (as discussed in point 7), not a separate training set.
§ 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).