(154 days)
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm44cm (8.7in17.3in)) is wrapped around the single upper arm.
Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate.
This document is a 510(k) Summary for a medical device called an "Arm automatic blood pressure monitor" (various models). The purpose of this summary is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information provided, extracting the requested details:
Acceptance Criteria and Device Performance
The acceptance criteria for accuracy are based on the ANSI/AAMI/ISO 81060-2:2009 standard for non-invasive sphygmomanometers. While the document mentions that a repeated clinical test for the subject devices was "unnecessary" due to technical similarity with the predicate, the predicate device's performance, which the subject devices claim substantial equivalence to, is detailed in a comparison table.
Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Predicate Device Claimed Performance) | Reported Device Performance (Subject Device Claimed Performance) | Basis for Acceptance/Performance |
|---|---|---|---|
| Accuracy - Pressure | ±3 mmHg (±0.4 kPa) | ±3 mmHg (±0.4 kPa) | Claimed identical to predicate |
| Accuracy - Pulse | ±5% | ±5% | Claimed identical to predicate |
| Measurement Range - Pressure | 0 mmHg ~ 280 mmHg (0 kPa ~ 37.3 kPa) | 0 mmHg ~ 280 mmHg (0 kPa ~ 37.3 kPa) | Claimed identical to predicate |
| Measurement Range - Pulse | 40 bpm ~ 180 bpm | 40 bpm ~ 180 bpm | Claimed identical to predicate |
| Operating Environment - Temperature | +5℃ ~ +40℃ | +5℃ ~ +40℃ | Claimed identical to predicate |
| Operating Environment - Humidity | 15% ~ 93% | 15% ~ 93% | Claimed identical to predicate |
| Operating Environment - Pressure | 70.0 kPa ~ 106.0 kPa | 70.0 kPa ~ 106.0 kPa | Claimed identical to predicate |
| Operating Environment - Altitude | ≤ 3000 m | ≤ 3000 m | Claimed identical to predicate |
| Storage/Transport Environment - Temperature | -25℃ ~ +70℃ | -25℃ ~ +70℃ | Claimed identical to predicate |
| Storage/Transport Environment - Humidity | 10% ~ 95% | 10% ~ 95% | Claimed identical to predicate |
| Storage/Transport Environment - Pressure | 50.0 kPa ~ 106.0 kPa | 50.0 kPa ~ 106.0 kPa | Claimed identical to predicate |
Study Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states that a repeated clinical test for the subject devices was unnecessary because the subject devices are identical to the predicate device from a technical point of view, and the differences (Power Source, Weight, Size, Broadcast Function) do not relate to blood pressure measurement technology. Therefore, no new clinical test data for the subject devices is provided in this summary.
- The provenance of the data for the predicate device's clinical validation (which established the acceptance criteria for these equivalence claims) is not detailed in this document. It is implied that the predicate device (K151258) met the ANSI/AAMI/ISO 81060-2:2009 standard, but the specific details of that study are not provided in this submission.
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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)
- Since a new clinical test for the subject device was deemed "unnecessary," there would be no new ground truth established for the subject device in this submission. The ground truth for the predicate device's accuracy would have been established during its original clinical validation against the ANSI/AAMI/ISO 81060-2:2009 standard, which typically involves comparing automated measurements to those taken by trained observers using a reference sphygmomanometer. Details on the number or qualifications of these "experts" (trained observers) are not provided in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No new clinical test was performed for the subject device, so no adjudication method is mentioned for its test set. The ANSI/AAMI/ISO 81060-2 standard outlines procedures for obtaining reference blood pressure measurements, often involving multiple observers to minimize bias, but the specific method used for the predicate device's validation is not detailed here.
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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
- This is not applicable. The device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The core functionality of an "Arm automatic blood pressure monitor" is inherently standalone. It uses an oscillometric technique to calculate blood pressure and pulse rate without human intervention during the measurement process. The comparison tables indicate the subject device and predicate device "use the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate." This implies a standalone algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For blood pressure monitors, the "ground truth" during clinical validation (following standards like ANSI/AAMI/ISO 81060-2) is typically established by simultaneous auscultatory measurements performed by trained observers using a calibrated reference sphygmomanometer. This is considered an expert comparison or reference measurement.
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The sample size for the training set
- This document does not specify a training set as it focuses on demonstrating substantial equivalence rather than detailing the development and initial validation of the algorithm itself. The
oscillometric methodused is a well-established technique for blood pressure measurement, and any "training" (e.g., development of the algorithm's parameters) would have occurred during the initial design and validation of the predicate device's core technology, which is not described here.
- This document does not specify a training set as it focuses on demonstrating substantial equivalence rather than detailing the development and initial validation of the algorithm itself. The
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How the ground truth for the training set was established
- As no training set is explicitly discussed in this document for the subject device, the method for establishing its ground truth is not provided. For oscillometric devices, the algorithm's parameters are typically derived and refined based on clinical data where the device's readings are compared against standard reference measurements.
§ 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).