(254 days)
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to ther populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Digital Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist. Digital Blood Pressure Monitor JWS-1000, JWS-970, JWS-950, JWS-940, JWS-706, JWS-705. JWS-704. JWS-703. JWS-701. JWS-700. JWS-600. BC20. BC40 have the same technology, main function, performance and intended use, and they are consistent in product structure and material.
The provided text describes a 510(k) premarket notification for a Digital Blood Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, many of the requested details, such as specific performance metrics with acceptance criteria, sample sizes for test and training sets, details on expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not explicitly provided in this type of regulatory document.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states that the device conforms to several standards, implying that the acceptance criteria are those specified in these standards. The device's performance is reported as meeting these standards and being "statistically and clinically acceptable."
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| IEC80601-2-30:2009 +Amendment 1:2013 | Conforms to standard |
| ANSI/AAMI/ISO 81060-2:2009 | Conforms to standard (specifically mentions "in its entirety" for the clinical study) |
| BS EN1060-4: 2004 | Conforms to standard (specifically mentions "in its entirety" for the clinical study) |
| AAMI / ANSI ES 60601-1:2005/(R)2012 +A1: 2012 and C1:2009/(R)2012 and, a2:2010/(r)2012 | Conforms to standard |
| IEC 60601-1-2 Edition 3: 2007-03 | Conforms to standard |
| Clinical repeatability | Statistically and clinically acceptable |
| Measurement Accuracy | Stated as equivalent to predicate device (which adheres to the above standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the document. The document only mentions "A comparison study" was performed. Standards like ANSI/AAMI/ISO 81060-2 usually specify minimum sample sizes for validation (e.g., typically at least 85 subjects).
- Data Provenance: Not explicitly stated. The manufacturer is based in China, so it's possible the study was conducted there, but this is not confirmed.
- Retrospective or Prospective: Not explicitly stated. Clinical validation studies for blood pressure monitors are typically prospective.
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)
- The clinical study involved a "comparison study with a device that uses auscultatory method used by trained observers."
- Number of Experts/Observers: Not explicitly stated (the standard ANSI/AAMI/ISO 81060-2:2009 typically requires at least two trained observers).
- Qualifications of Experts: Described as "trained observers." No further details on their specific qualifications or years of experience are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document implies adherence to ANSI/AAMI/ISO 81060-2:2009, which outlines specific methodologies for comparing automated blood pressure measurements with those obtained by trained observers using a reference method (auscultation). This typically involves multiple readings and a procedure for handling discrepancies, often implicitly using a consensus or comparison against a standard. However, the specific adjudication method (e.g., 2+1, 3+1) is not detailed in this summary.
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
- No MRMC study was mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, this question is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The entire clinical study described is a standalone validation of the device's accuracy ("clinical repeatability") against a reference method (auscultatory method by trained observers). The device itself operates as an algorithm determining blood pressure without human intervention in the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Expert comparison/reference method: The ground truth was established by "a device that uses auscultatory method used by trained observers." The auscultatory method, employing a stethoscope and manometer, is the traditional reference standard for non-invasive blood pressure measurement.
8. The sample size for the training set
- Not applicable / not provided. This document describes a medical device clearance based on demonstrable performance against a predicate and recognized standards. It's not a submission for an AI/ML model that typically details training sets for deep learning or similar algorithms. The "training" for such a device is in its design and calibration, not in a separate machine learning training set as might be asked for an AI diagnostic algorithm.
9. How the ground truth for the training set was established
- Not applicable / not provided. As mentioned above, this is not an AI/ML model submission that would involve a distinct "training set" with ground truth established through labeled data for an algorithm to learn from.
§ 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).