(306 days)
The device is noninvasive and provide Systolic, Diastolic blood pressure and pulse rate(heart rate) mesurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD Panel. The Device is indicated for use by people over 15 age old in home use.
GENTEEL BP-100 Wrist Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
Here's a breakdown of the acceptance criteria and study information for the GENTEEL BP-100 Wrist Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The provided document indicates that the device's performance was evaluated against applicable standards. The general acceptance criteria are implied by conformity to these standards, rather than explicitly stated numerical thresholds in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conforms to EN-1060-3 | "the device conforms to applicable standards included EN-1060-3" |
| Conforms to ANSI/AAMI SP-10 | "the device conforms to applicable standards included ... ANSI/AAMI SP-10" |
| Conforms to IEC 60601-1-2 | "the device conforms to applicable standards included ... and IEC 60601-1-2 requirements" |
| Clinical repeatability | "The comparison study demonstrated that the clinical repeatability of GENTEEL BP-100 Wrist Blood Pressure Monitor is statistically and clinically acceptable." (No specific numerical values for repeatability are provided.) |
Study Information
The document describes a "comparison study" as the primary evidence for validating the performance of the GENTEEL BP-100 Wrist Blood Pressure Monitor.
- Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study used an "auscultatory method" for comparison. This implies that human observers (likely trained medical professionals such as doctors or nurses) were involved in taking the blood pressure readings manually using a stethoscope and sphygmomanometer, which would serve as the ground truth.
- Number of Experts: Not specified.
- Qualifications: Not specified (e.g., "physicians with X years of experience").
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The nature of the auscultatory method usually involves a single trained observer taking a reading, or potentially multiple observers with their readings averaged or adjudicated. The document does not provide these details.
- 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, an MRMC comparative effectiveness study was not done. This study is a direct comparison of the device against a manual (auscultatory) method, not a study of human readers assisted by AI. The device itself is a measurement tool, not an AI diagnostic aid for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The GENTEEL BP-100 Wrist Blood Pressure Monitor is a standalone device that measures blood pressure without human interpretation of its outputs. Its performance was tested by comparing its readings to those obtained via the auscultatory method.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Expert auscultatory readings. The ground truth was established by readings obtained using the "auscultatory method," which is the gold standard for non-invasive blood pressure measurement and relies on a trained human observer.
- The sample size for the training set:
- Not applicable/Not specified. The document does not describe a training set as this is not an AI/machine learning device requiring such. The comparison study is likely a validation study against an established method.
- How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no described training set.
§ 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).