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Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 15cm-48cm (approx. 5.9"-18.9").

Fully Automatic Electronic Blood Pressure Monitor (BP-300C, BP-300CV, BP-300V, BPM1, BPX1, KD-338N, KD-553, KD-557BR, KD-558, KD-558BR, KD-595, KD-5031N, KD-5810, KD-5810B, KD-5811, KD-5811A, KD-5811V, KD-5815, KD-5920, KD-5920L, KD-5920TL, KD-5923, KN-550LT) is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on Oscillo-metric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure and display the result. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided document is a 510(k) clearance letter for various blood pressure monitors. It outlines the regulatory approval process and compares the new devices to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format typically used for AI/software devices.

Specifically, this document describes validation against standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and automated non-invasive sphygmomanometers (IEC 80601-2-30, ISO 81060-2). It focuses on the substantial equivalence of the physical blood pressure monitors and their underlying oscillometric and pressure sensor technology, rather than the performance of an AI algorithm based on a test set, ground truth, and expert interpretations.

Therefore, many of the specific questions about AI/software device validation (e.g., sample size for the test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) cannot be answered from this document.

However, I can extract information related to the performance of the blood pressure monitors themselves, based on the included standards.

Acceptance Criteria and Device Performance (for Blood Pressure Monitor functionality, not AI):

Since this is a blood pressure monitor, the primary performance criteria relate to its accuracy in measuring blood pressure and pulse rate, and compliance with relevant safety and performance standards for automated non-invasive sphygmomanometers.

• IEC 60601-1:2005+AMD1: 2012+AMD2: 2020
• IEC 60601-1-2:2014+AMD1: 2020
• IEC 60601-1-11: 2015+AMD1: 2020
• IEC 80601-2-30: 2018 | All listed standards were met, demonstrating basic safety, essential performance, EMC, and home healthcare environment compliance. |

Unable to Answer from Document (Common for AI/Software Device Submissions, but not for this type of device):

The following questions are not applicable or cannot be answered from this 510(k) summary because the device described is a physical blood pressure monitor, not an AI/software device that interprets medical images or other complex data requiring expert adjudication, training sets, or MRMC studies.

• Sample size used for the test set and the data provenance:
  • Test Set Size: "A total of 231 patients (107 males and 124 females) were enrolled in the study." This is the clinical study population for blood pressure measurement accuracy.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study," which implies prospective data collection for the purpose of the study.
• 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. Ground truth for blood pressure measurement is established through a standard auscultation method (manual measurement by medical professionals using a stethoscope and sphygmomanometer), not by interpretation of images by experts.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not applicable. Ground truth is direct measurement by a reference method.
• 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 is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The device is a standalone blood pressure monitor. No human-in-the-loop interaction for interpretation (as in AI devices) is relevant. Its performance is its direct measurement accuracy.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Ground Truth: "Standard auscultation method was used as the reference blood pressure monitor measuring." This is the established clinical standard for direct comparison.
• The sample size for the training set:
  • Not applicable. This is not an AI/machine learning device requiring a training set.
• How the ground truth for the training set was established:
  • Not applicable.

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