(78 days)
The A&D LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UA-704 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by pressing a bulb manually by the user. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the quick exhaust valve. The measurement results are displayed on the LCD. UA-704 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
The provided document is a 510(k) Summary for the A&D LifeSource UA-704 Digital Blood Pressure Monitor. It describes the device, its intended use, and its substantial equivalence to predicate devices. The document highlights that the device was tested against the NIST/AAMI SP-10 standard and FDA guidance for Non-invasive Blood Pressure (NIBP) Monitors.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The device's acceptance criteria are based on meeting the NIST/AAMI SP-10 standard for non-invasive blood pressure monitors. The "Test Results & Comments" column in the table indicates whether the device "Conformed" to each section of the standard.
| SP-10 Section # | Section Title | Test Results & Comments |
|---|---|---|
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-aeterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual | Conformed |
Study Details:
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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 does not specify a sample size for a clinical test set. It explicitly states: "UA-704 is not clinically tested." Testing was conducted against the SP-10 standard, which involves technical and performance evaluation, not a human subject study for efficacy in the same way a diagnostic AI would be tested.
- Data Provenance: Not applicable as no clinical test set using human data is mentioned.
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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):
- Not applicable. Since there was no clinical testing on human subjects, there was no need for experts to establish ground truth in this context. The standard itself defines accuracy requirements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set involving human subjects requiring adjudication is mentioned.
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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:
- No. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing against the SP-10 standard evaluates the device's technical performance in a standalone manner, ensuring its accuracy and adherence to specifications without direct human intervention in the measurement process (beyond operating it as intended). The statement "UA-704 uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate" further supports its standalone operational capability mirroring previous approved devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Overall system efficacy" (Section 4.4.2), the standard specifies the "Auscultatory method as the reference standard" (Section 4.4.2.1). This means the ground truth for blood pressure measurements would be derived from simultaneous measurements taken by a trained observer using a stethoscope and sphygmomanometer, which is the traditional clinical gold standard for non-invasive blood pressure. The other reference standard, "Intra-aeterial method," was "Not applicable."
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The sample size for the training set:
- Not applicable. The document does not describe the use of machine learning or AI that would require a distinct "training set." The device relies on established oscillometric principles and "identical software codes and pressure detection related hardware as the predicate devices."
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How the ground truth for the training set was established:
- Not applicable. As no training set for a machine learning model is mentioned, the method for establishing its ground truth is also not applicable.
§ 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).