(27 days)
The A&D Medical UM-101 digital blood pressure monitor is intended for use by medical professionals for measuring the systolic and diastolic blood pressure and pulse rate.
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D Medical UM-101 digital blood pressure monitor is intended for use by medical professionals for measuring the systolic and diastolic blood pressure and pulse rate. UM-101 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated manually by the medical professionals. The systolic and diastolic blood pressures are determined by auscultatory method. The deflation rate is regulated by a mechanical valve controlled by the medical professionals. There is a quick release valve so that the pressure of the cuff can be completely released at any time during the measurement. During the deflation, the systolic and diastolic can be marked by the medical professionals through a "MARK" button. UM-101 has an internal counter so it remembers the number of measurements. The information can be retrieved by holding the "MARK" button.
The provided text is a 510(k) summary for the A&D Medical UM-101 Digital Blood Pressure Monitor. It outlines the device's technical characteristics and the standards it meets. However, it does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance that you requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device by listing the standards the device meets. These standards effectively serve as the acceptance criteria for this particular device submission rather than specific performance metrics from a clinical study.
Here's a breakdown of the information that can be extracted or inferred, and a clear statement about what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP-10 standard | (Not explicitly detailed in terms of specific performance metrics like accuracy or bias from a clinical study) |
| European Directive 93/42 EEC for Medical Products | (Not explicitly detailed) |
| EN60601 General Safety Provisions | (Not explicitly detailed) |
| EN60601-2-30 Particular Requirements for the Safety of BP Monitor | (Not explicitly detailed) |
| EN60601-1-2 and EN55011 Electromagnetic Compatibility | (Not explicitly detailed) |
Missing Information: The document states the device meets these standards, but it does not provide the specific performance metrics (e.g., mean difference, standard deviation of differences for blood pressure readings) that would typically be reported from a clinical validation study against a reference standard to demonstrate compliance with these standards. For devices like blood pressure monitors, ANSI/AAMI SP-10 would have specific accuracy requirements that the device would need to meet.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not provide any information about a specific clinical test set, sample size, or data provenance. The assessment appears to be based on compliance with general and specific medical device standards rather than a detailed clinical validation study described in the summary.
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)
Missing Information: This information is not provided as no clinical test set or ground truth establishment process is described beyond adherence to general standards. For a blood pressure monitor, the "ground truth" during testing typically involves comparison against measurements taken by trained observers using a reference method (e.g., auscultation with a manometer) rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This information is not provided as no clinical test set or adjudication process is described.
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/Missing Information: This is a blood pressure monitor, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study is not relevant in this context, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Applicable (in a different sense): The device itself is a "standalone" blood pressure monitor that provides a reading. It's not an algorithm in the sense of AI performing a diagnostic task. The performance would be its inherent accuracy in measuring blood pressure. However, the document does not provide standalone accuracy metrics from a clinical study against a reference standard. It only states compliance with standards like ANSI/AAMI SP-10, which imply acceptable standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing Information (beyond inference): The document does not explicitly state the type of ground truth used for compliance with the listed standards. For blood pressure monitors, the "ground truth" in standard validation protocols (like AAMI SP-10) typically involves simultaneous auscultatory measurements by trained observers or other reference methods.
8. The sample size for the training set
Not Applicable/Missing Information: This device is a traditional blood pressure monitor, not an AI/ML-based algorithm that requires a "training set." Therefore, this concept is not relevant, and no such information is provided.
9. How the ground truth for the training set was established
Not Applicable/Missing Information: As mentioned above, this is not an AI/ML device, so a training set and its associated ground truth establishment are not applicable.
In summary: The provided 510(k) summary focuses on demonstrating compliance with recognized standards (ANSI/AAMI SP-10, European Directives, EN standards for safety and EMC) to establish substantial equivalence. It does not provide the specific detailed clinical validation study results (like sample sizes, expert qualifications, exact performance metrics) that would typically be contained within a more comprehensive clinical data section of a 510(k) submission, even though such studies are generally performed to meet these standards.
§ 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).