(245 days)
FB-270/DS-270 is a portable blood pressure monitor for non-invasive blood pressure measurement, monitoring intraday variance of blood pressure in daily life. They measure systolic and diastolic blood pressure and heart rate, at set interval within 24/48 hours or manually, and store the data to SD card (memory card). The collected data can ensure the change in the day of the blood pressure in the personal computer using CD-ROM for exclusive setup. Physicians at medical institutions will check the data on personal computer for analysis of hypertensive and hypotensive diseases.
Ambulatory Blood Pressure Monitor FB-270/DS-270 measures highest and lowest blood pressure and heart rate, automatically at interval within 24/48 hours or manually, by its measuring algorithm written in SD card (memory card) inserted into FB-270/DS270. The measuring algorithm is written into SD card by personal computer with specific software installed. Physicians at medical institutions will check stored data of intraday blood pressure variance in daily life on personal computer. This device consists of Cuff main unit employing both Riva-Rocci Korotkov method and oscillometric method, and cuff unit. The cuff can be applied to upper arm circumference in range of 9.06 in. to 12.6 in. (230 mm to 320 mm) for Cuff respectively. Microphone detecting Korotkov sound is incorporated into the device. The cuff consists of pressurizing blooder and nylon cover, and the device consists of microcomputer, event switch, pump, electronically controlled exhaust valve, microphone and indicator. Programming to the device, readout of data measured by the device, and analysis of measurement results are executed by personal computer with exclusive analysis software BH-270 installed. Programming to SD card and readout of measured data from SD card are executed by general use memory reader. Physicians can analyze various graphs such as trend graph, distribution map, histogram, correlation diagram displayed on PC.
The provided text describes the Ambulatory Blood Pressure Monitor FB-270/DS-270 and its substantial equivalence to predicate devices, focusing on technical characteristics and safety testing rather than a specific clinical study with detailed acceptance criteria and reported device performance.
Therefore, many of the requested items cannot be fully extracted based on the provided document. However, I can provide information on what is available:
1. A table of acceptance criteria and the reported device performance
The document states that the device was subjected to tests according to IEC60601-1 (electrical safety), IEC60601-1-2 (electromagnetic compatibility), and ANSI/AAMI SP10 (blood pressure measurement accuracy). It reports that the device "passed the tests of these standards and met the requirements."
- Acceptance Criteria (General): Meeting the requirements of IEC60601-1, IEC60601-1-2, and ANSI/AAMI SP10.
- Reported Device Performance: "passed the tests of these standards and met the requirements."
Specific numerical acceptance criteria and performance metrics (e.g., mean difference and standard deviation for blood pressure measurements as per ANSI/AAMI SP10) are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to a "clinical study made for DS-240 according to ANSI/AAMI SP10" and states its applicability to the subject device, suggesting that no new clinical study specifically for the FB-270/DS-270 was conducted or detailed in this summary.
3. 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)
This information is not provided. As implied above, a new clinical study with expert ground truth establishment for the FB-270/DS-270 is not explicitly detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable. The device is an Ambulatory Blood Pressure Monitor, which measures physiological parameters. It is not an AI-assisted diagnostic imaging device requiring a multi-reader multi-case study or assessing human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "standalone" in its measurement function (algorithm only). The measurement algorithm itself is described as performing measurements without human intervention during the monitoring period. Its performance is assessed against the ANSI/AAMI SP10 standard, which evaluates the accuracy of the blood pressure measurement algorithm directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors evaluated against standards like ANSI/AAMI SP10, the "ground truth" typically involves simultaneous measurements by trained observers using a reference standard (e.g., mercury sphygmomanometer) following a specific protocol. The document states "Because there is no technical difference of measuring algorithm and measuring accuracy, we consider clinical study made for DS-240 according to ANSI/AAMI SP10 is also applicable to the subject device." This implies the ground truth for the predicate device's study (DS-240) would have been established according to the ANSI/AAMI SP10 standard, which requires expert comparison measurements.
8. The sample size for the training set
This information is not provided. The document describes the device's measurement algorithm, but does not discuss training data for an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not provided. The document does not describe the training of a machine learning model, and therefore no ground truth for a training set is discussed.
§ 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).