(288 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 device is an Arm automatic blood pressure monitor, and the provided text describes its substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and performance metrics in the typical sense of AI/ML device studies. This document is a 510(k) summary from the FDA.
However, I can extract the relevant "acceptance criteria" for blood pressure measurement accuracy based on the provided specifications, and then infer how it meets these based on the comparison to the predicate device and the referenced standard.
Inference from the text:
The device is an automatic blood pressure monitor that uses an oscillometric technique. The "acceptance criteria" are implied by the accuracy specification listed in the comparison table and the adherence to the IEC 80601-2-30 standard, which defines accuracy requirements for automated sphygmomanometers.
1. A table of acceptance criteria and the reported device performance:
| Criteria Category | Acceptance Criteria (from predicate device specifications) | Reported Device Performance (Implied for Subject Device) |
|---|---|---|
| Measurement Accuracy (Pressure) | ±3mmHg (±0.4kPa) | The subject device is identical in measurement principle and algorithm, and based on substantial equivalence, is implied to also meet ±3mmHg (±0.4kPa) accuracy. |
| Measurement Accuracy (Pulse) | ±5% | The subject device is identical in measurement principle and algorithm, and based on substantial equivalence, is implied to also meet ±5% accuracy. |
| Measurement Range (Pressure) | 0mmHg | Identical to predicate device. |
| Measurement Range (Pulse) | 40 bpm ~ 180 bpm | Identical to predicate device. |
| Intended Use | Measure systolic, diastolic BP, and pulse rate of an adult individual using non-invasive oscillometric technique with cuff (22-44cm) on upper arm. Over-The-Counter use. | Identical to predicate device. |
| Regulatory Standards | Adherence to IEC 80601-2-30 (specifically 2009 & A1:2013) | Confirmed by manufacturer's statement: "tested met all relevant requirements of the aforementioned tests." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document explicitly states: "Therefore repeated clinical test in accordance with the standard IEC 80601-2-30:2009 & A1:2013 is unnecessary." This indicates that no new clinical test set was used for the subject device to re-evaluate its accuracy for blood pressure measurement. Instead, substantial equivalence was established based on the technical similarity to the predicate device, which would have undergone clinical testing to meet the IEC 80601-2-30 standard. The IEC 80601-2-30 standard typically requires a clinical validation study with a specified number of subjects (e.g., at least 85 subjects for validation, including sufficient numbers in different blood pressure ranges). However, the specific sample size for the predicate is not provided in this document.
- Data Provenance: Not applicable for a new clinical test set for the subject device because it was deemed unnecessary. For the predicate device's validation (which the subject device is relying upon for clinical accuracy), the provenance is not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no new clinical test set was performed for the subject device. For the predicate device's validation, the IEC 80601-2-30 standard requires a specific methodology for reference measurements, typically involving trained observers using a mercury sphygmomanometer or auscultation, but the exact number and qualifications of experts for the predicate's original study are not specified here.
4. Adjudication method for the test set:
- Not applicable as no new clinical test set was performed for the subject device. For the predicate device's validation, the IEC 80601-2-30 standard details the requirements for obtaining reference blood pressure measurements (ground truth), which often involves multiple observers and a consensus or averaging approach.
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. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The device is an "automatic blood pressure monitor" that uses an "oscillometric technique" and "software calculates the systolic and diastolic blood pressure and pulse rate." This is a standalone algorithm (device) performance measurement. The accuracy criteria (Pressure: ±3mmHg, Pulse: ±5%) are for this standalone performance. The document states that because the technical aspects influencing blood pressure measurement were identical to the predicate, a repeated clinical test was unnecessary, meaning the standalone performance of the subject device is considered to meet the same accuracy standards as the predicate, which would have been established through a standalone clinical validation.
7. The type of ground truth used:
- For the clinical validation implied by adherence to IEC 80601-2-30, the ground truth for blood pressure measurements is typically established through auscultation by trained observers using a reference standard like a mercury sphygmomanometer. This involves direct physiological measurement.
8. The sample size for the training set:
- Not applicable in the context of typical AI/ML training sets. This device uses a "pressure vibration method" and a "software algorithm" for calculation, but the document does not describe it as an AI/ML device that requires a distinct "training set" for model development in the machine learning sense. The algorithm would have been developed and fine-tuned based on engineering principles and potentially clinical data, but not referred to as a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as no described training set in the AI/ML sense. The algorithm's development would follow standard medical device software engineering practices, with performance validated against reference physiological measurements based on established medical standards (e.g., auscultation).
§ 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).