(114 days)
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries.
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
Unfortunately, the provided document K091434 for the Truly Automatic Arm Blood Pressure Monitor does not contain the specific details required to answer your questions about acceptance criteria and the study proving the device meets them.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance testing against explicit acceptance criteria.
Here's what is (and isn't) present in the document regarding your questions:
1. A table of acceptance criteria and the reported device performance
- What's in the document: The summary provides "Accuracy Pressure: ± 3mmHg" and "Accuracy Pulse: ± 5%" under "Table 1" and "Table 2" when comparing to predicate devices. This represents the claimed accuracy, which would likely be the acceptance criteria, but no formal study data proving this performance is presented within this document.
- What's missing: The document does not present a table explicitly laying out acceptance criteria from a validation study alongside the performance results from that study. It merely lists the stated accuracy specifications as a comparison point during the substantial equivalence argument.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not present in the 510(k) summary. It does not describe any clinical or performance test setup, subject numbers, or data origin.
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: This information is not present. The device is a non-invasive blood pressure monitor, and its ground truth typically relies on a reference measurement method (like a mercury sphygmomanometer with auscultation), not necessarily "experts" in the context of image interpretation. However, the exact reference method and its application details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: This information is not applicable and not present. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a blood pressure monitor, reconciliation would be against the reference standard.
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
- Missing: Not applicable and not present. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- What's in the document: The device itself is a "standalone" automatic blood pressure monitor, meaning its measurement is solely algorithmic without human intervention in the measurement process (though a human operates the device). The document states it uses the "oscillometric method" and an "electronic pressure sensor."
- What's missing: While the device operates standalone, the document doesn't explicitly describe a "standalone performance study" in the context of comparing its algorithm-only performance against a human or a different standard. It just states its general operating principle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing: The document does not explicitly state the ground truth method used for any performance testing. For blood pressure monitors, the ground truth is typically obtained from simultaneous measurements using a validated reference method (e.g., a mercury sphygmomanometer with a trained observer using auscultation), adhering to standards like ANSI/AAMI SP10. This is implied to be the basis for claiming "Accuracy Pressure: ± 3mmHg," but the details are not provided.
8. The sample size for the training set
- Missing: Training sets specifically for an algorithm are not mentioned. The "oscillometric method" is described as a "well-known technique in the market." If there were any machine learning components, a training set would be relevant, but this document does not provide such details.
9. How the ground truth for the training set was established
- Missing: As no training set is described, this information is also absent.
In summary, the K091434 submission is a 510(k) summary focused on establishing substantial equivalence based on technical similarities and stated performance specifications, rather than detailing the full performance study data against explicit acceptance criteria. To find the information you're looking for, you would typically need to review the full 510(k) submission and its accompanying test reports, which are not included in this summary document.
§ 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).