(90 days)
The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 with Optional Thermal Printer, Model PR 1KA1 is a device 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. This device can be used in connection with the Microlife Thermal Printer.
The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 is 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 capacitive 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". An optional printer is included as an accessory which can be sold separately in a separate box with the printer user manual.
The provided text describes the Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model PR 1KA1.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | The BP-3BTO-1 met all relevant requirements of this standard. |
| FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND (Electrical, Mechanical and Environmental Performance Requirements) | The device met all relevant requirements of the aforementioned tests (General Functions, Reliability (Operation Conditions, Drop, Storage, Vibrating), EMC, IEC 60601-1 Safety, Printer Port Function, Thermal Printer Software Validation, EMC with Printer). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of subjects) used for the clinical testing in accordance with ANSI/AAMI SP10-1992.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to the ANSI/AAMI SP10-1992 standard for clinical testing. This standard typically involves comparison of the automated device readings against auscultatory measurements performed by trained observers (experts). However, the specific number of experts and their qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided 510(k) summary.
4. Adjudication Method for the Test Set
The document does not explicitly describe the adjudication method (e.g., 2+1, 3+1, none) for the test set. For blood pressure measurement, the ground truth is typically established by trained observers taking multiple readings.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human readers interpret results, and the AI's effect on their performance is evaluated. This device is an automated blood pressure monitor, and its performance is assessed against a standard, not in terms of improving human reader effectiveness.
6. Standalone Performance Study
Yes, a standalone study was performed. The entire clinical testing section (Discussion of Clinical Tests Performed) is dedicated to evaluating the device's performance (i.e., algorithm only without human-in-the-loop performance) against the ANSI/AAMI SP10-1992 standard. The statement "The BP-3BTO-1 met all relevant requirements of this standard" confirms the standalone performance evaluation.
7. Type of Ground Truth Used
The ground truth for the clinical testing (per ANSI/AAMI SP10-1992) would typically involve expert auscultatory measurements. These are considered the "expert consensus" or "reference method" in blood pressure measurement testing. The device states its method is "similar to the auscultatory method" in its description.
8. Sample Size for the Training Set
The document does not provide information regarding a specific "training set" sample size. This device relies on an "oscillometric method" and a software algorithm. While the algorithm was developed, the submission focuses on validation against a standard, not on a machine learning training paradigm with a distinct training set. The "fuzzy logic inflation" and "split slope resolution" are algorithmic improvements, but information about a formal "training set" as understood in modern AI development is absent.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" in the context of modern machine learning, there is no information on how ground truth for such a set was established. The device uses a well-known "oscillometric method" and algorithmic enhancements, implying that the underlying principles and parameters of the algorithm were likely developed based on established physiological principles and empirical data, rather than a separate, labeled "training set" in the AI sense.
§ 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).