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Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Automatic Upper Arm Blood Pressure Monitor:

This document is a 510(k) Summary for a medical device called "Automatic Upper Arm Blood Pressure Monitor" (Model: BA-815, BA-816) by DONGGUAN E-TEST TECHNOLOGY CO., LTD. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document states: "All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission." This means that the acceptance criteria and performance data presented implicitly refer to the predicate device, as the subject device is deemed identical.

Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure monitor. The performance criteria are defined by the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.

Study Details (Based on the predicate device's compliance with AAMI / ANSI / ISO 81060-2)

Since "no new testing is presented in the submission" and the subject device is identical to the predicate, the compliance is based on the predicate device's clinical validation to AAMI / ANSI / ISO 81060-2 Second Edition. This standard outlines the requirements for clinical validation studies for automated non-invasive sphygmomanometers. The details below are inferred requirements from that standard, as the specific clinical study report is not provided in this 510(k) summary.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The AAMI / ANSI / ISO 81060-2 standard generally recommends a minimum of 85 participants for clinical validation studies, with a balanced distribution across age groups, genders, and blood pressure ranges (normotensive, hypertensive, hypotensive) to ensure robustness. The document does not explicitly state the sample size used in the predicate's study.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies according to AAMI are typically prospective in nature, conducted in a controlled clinical environment.

2. 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):

   • The AAMI / ANSI / ISO 81060-2 standard requires at least two trained observers (experts) to perform simultaneous auscultatory measurements using a mercury sphygmomanometer as the reference standard (ground truth). These observers should be blinded to each other's readings and to the device under test.
   • The standard typically requires observers to be medically trained professionals (e.g., physicians, nurses) with demonstrated proficiency in indirect blood pressure measurement. Specific years of experience are not explicitly stated in the general overview of the standard but implied through training and certification. The document does not explicitly state the number or qualifications of experts for the predicate's study.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The AAMI / ANSI / ISO 81060-2 standard outlines specific protocols for comparing the automated device readings against the auscultatory measurements. If the two observers' readings differ by more than a predefined threshold, a third observer ("2+1") or a repeat measurement might be required to establish the ground truth or resolve discrepancies.
   • The document does not explicitly state the adjudication method used for the predicate's study, but a standard compliant study would have such a method.

4. 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 type of study is relevant for imaging analysis or diagnostic aids where human interpretation is assisted by AI. This device is an automated blood pressure monitor; it does not involve human "readers" or AI assistance for interpretation in the same way an imaging system would. It provides direct numerical outputs for blood pressure and pulse rate.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone study was done. The clinical validation per AAMI / ANSI / ISO 81060-2 is fundamentally a standalone clinical performance study. The automatic blood pressure monitor operates on its own, providing measurements, and its performance is compared directly against the reference standard (auscultatory method). There is no "human-in-the-loop" for the device's measurement process itself, although human interaction is required to apply the cuff and initiate the measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth used for validating the accuracy of non-invasive blood pressure monitors under AAMI / ANSI / ISO 81060-2 is simultaneous auscultatory measurement performed by trained human observers using a mercury sphygmomanometer. This is considered the clinical reference standard for indirect blood pressure measurement.

7. The sample size for the training set:

   • Since no new testing was performed for the subject device and it is stated that "All hardware and software of the subject device are based on that of the predicate device," there is no specific mention of a training set for the subject device or for the predicate device's original validation. Automated blood pressure monitors are often developed and calibrated using internal data, but the AAMI validation focuses on clinical performance rather than a 'training/test' split akin to machine learning models. If the device uses a machine learning algorithm, the training set details would typically be proprietary and not disclosed in a 510(k) summary (unless it directly impacts the safety and effectiveness and needs specific validation).

8. How the ground truth for the training set was established:

   • As there's no explicitly mentioned "training set" in the context of this 510(k) summary, the method for establishing its ground truth is not provided. For the initial development and calibration of such a device, ground truth would likely be established through a combination of simulated physiological signals and clinical data obtained using reference methods like direct intra-arterial measurements or auscultatory measurements.

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FDBP A series Upper Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse and children at least 12 years of age, at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia). with the cuff around the left upper arm according to the instruction in the user's guide manual.

FDBP A series Upper Arm Blood Pressure Monitor (Model:FDBP-A8,FDBP-A11,FDBP-A12,FDBP-A14 )includes utilize modular design method, It consists of nine main modules: power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, voice broadcast processing module, and each module communicates through a message queue. The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; Single-chipped microcomputer will control the inflation module to release the pressure after receive measurements; in the meanwhile, display the measurements results then stored the values with memory module.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The studies conducted for the FDBP A Series Upper Arm Blood Pressure Monitor are divided into "Non-Clinical Data" and "Clinical Data."

2. Sample Size Used for the Test Set and Data Provenance:

• Non-Clinical Data:
  • The document does not explicitly state the sample size for individual biocompatibility, electrical safety, EMC, or bench testing. However, it indicates these tests were conducted on "all the modules and accessories in the system" and "all the patient contracting materials."
  • Data Provenance: Not specified, but given the manufacturer is Famidoc Technology Company Limited (China), it's highly probable the testing was conducted in China or by labs contracted by the Chinese manufacturer. The document doesn't specify if it's retrospective or prospective for non-clinical testing.
• Clinical Data:
  • The document states: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers -Part 2: Clinical validation of automated measurement type."
  • ISO 81060-2: 2013 typically requires a specific number of subjects for clinical validation. While the exact number is not provided in this document, the standard generally mandates a minimum of 85 subjects for validation in a mixed population.
  • Data Provenance: Not explicitly stated, but likely from a clinical study conducted either within China or a region where compliance with ISO 81060-2 is standard. The document doesn't specify if it's retrospective or prospective, but clinical validation studies are inherently prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• For the clinical validation (per ISO 81060-2):
  • ISO 81060-2 requires that the reference blood pressure measurements (the "ground truth") be obtained by at least two trained observers using a mercury sphygmomanometer or an equivalent validated reference device.
  • Qualifications of Experts: These observers must be specifically trained and certified to perform accurate auscultatory blood pressure measurements, adhering to strict protocols outlined in the standard. The document does not provide specific details on the individual qualifications of the "two trained observers" used in this particular study, but it is a prerequisite of the standard cited.

4. Adjudication Method for the Test Set:

• For the clinical validation (per ISO 81060-2):
  • The standard dictates a specific methodology where simultaneous (or near-simultaneous) measurements are taken by the device under test and the two trained observers. The average of the two observers' measurements typically serves as the reference (ground truth). Discrepancies between the observers' measurements might trigger re-measurements or specific rules for reconciliation, but a formal "adjudication" in the sense of a third expert resolving disagreements is not always explicitly a primary step unless the initial agreement criteria are not met. The document does not specify the exact adjudication method (e.g., 2+1, 3+1) beyond compliance with ISO 81060-2.

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 an automated blood pressure monitor for direct blood pressure measurement, not an AI-assisted diagnostic imaging device or an interpretation tool involving human "readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this type of medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, this is a standalone device. The FDBP A Series Upper Arm Blood Pressure Monitor is an automated device designed to measure blood pressure without human intervention in the measurement process (once the cuff is applied and the device activated). The "algorithm only" performance is the core function of such a device. The clinical validation conducted under ISO 81060-2 is precisely a standalone performance evaluation against a human-read auscultatory reference.

7. The Type of Ground Truth Used:

• Expert Consensus (Auscultatory Reference): For the clinical validation, the ground truth for blood pressure measurements is established by trained human observers using the auscultatory method (typically with a mercury sphygmomanometer or a validated equivalent), following the protocols defined in ISO 81060-2. This is considered an "expert consensus" in the context of blood pressure measurement.

8. The Sample Size for the Training Set:

• Not applicable/Not explicitly stated. As an automated blood pressure monitor, the device's core functionality relies on a pre-defined oscillometric algorithm rather than a "training set" in the context of machine learning or AI models. While the algorithm itself would have been developed and refined using data (which could be loosely considered "training"), the document does not provide details on such a training dataset or its size. The primary validation focuses on its clinical performance against expert-derived ground truth.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/Not explicitly stated. Similar to point 8, the document does not detail a "training set" for an AI algorithm. If an algorithm development process involved data, the ground truth for that development would likely have been established through a combination of simulated data, data from calibration devices, and potentially earlier validation studies against auscultatory measurements. However, the document does not provide these specifics.

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