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The Upper Arm Blood pressure Monitor 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 oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm42 cm or 22cm48cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor (Model:SP10A).

The provided text is an FDA 510(k) clearance letter for an Upper Arm Blood Pressure Monitor, Model SP10A. It primarily addresses the regulatory approval process and includes the device's indications for use.

Crucially, this document does NOT contain information about acceptance criteria, specific study designs (like sample sizes, data provenance, expert qualifications, or multi-reader studies), or the detailed performance metrics of the device against such criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present in the document.
• Sample sizes used for the test set and data provenance: Not detailed.
• Number of experts used to establish ground truth and qualifications: Not detailed.
• Adjudication method: Not detailed.
• MRMC comparative effectiveness study details: Not mentioned. This type of study is more common for AI/imaging devices, not a blood pressure monitor.
• Standalone (algorithm only) performance: Not applicable for this device.
• Type of ground truth used: Not detailed.
• Sample size for the training set: Not detailed.
• How ground truth for the training set was established: Not detailed.

For these details, one would typically need to refer to the full 510(k) submission or supporting clinical validation reports, which are not included in this FDA clearance letter. The letter confirms clearance based on substantial equivalence, but not the detailed study results that led to that determination.

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The Upper Arm Blood pressure Monitor 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 oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.

Upper Arm Blood pressure Monitor, Model SP10A

The provided text is a U.S. FDA 510(k) clearance letter for an "Upper Arm Blood Pressure Monitor, Model SP10A." It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or training set information.

Instead, the document primarily focuses on:

• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: References to applicable regulations (e.g., 21 CFR 870.1130 for noninvasive blood pressure measurement systems), general controls, and other requirements.
• Indications for Use: Describes the intended use of the device for measuring diastolic and systolic blood pressure and pulse rate in adults using an oscillometric technique, for use in hospital or home environments.
• Type of Use: Specifies that it is intended for Over-The-Counter Use.

To answer your request, a different type of document, such as a summary of safety and effectiveness, clinical study report, or specific test results, would be needed. The current document does not provide the detailed performance and study information you're asking for.

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This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.

The Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function. The four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.

This document describes the 510(k) summary for the "Upper Arm Blood Pressure Monitor" (Models: ZK-B868, ZK-B869, ZK-B872, ZK-B876) by ShenZhen ZhengKang Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to blood pressure measurement accuracy.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document mentions compliance with the standard ISO 81060-2 (Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type). This standard sets widely accepted accuracy criteria for blood pressure monitors.

While the document doesn't explicitly present a table of acceptance criteria and reported performance in a single table, it states the device "passed" the performance testing according to ISO 81060-2.

The Accuracy section within the comparison table (page 5) lists the following for the targeted device, which are the inherent performance characteristics the device aims to meet:

These values are consistent with the requirements of ISO 81060-2. The statement that the performance testing was "performed to, and passed" these standards implies that the device achieved these accuracies within the limits defined by ISO 81060-2.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for the clinical validation according to ISO 81060-2. It also does not specify the country of origin of the data, nor whether the study was retrospective or prospective.

ISO 81060-2 typically requires a prospective study with a specific number of subjects (usually 85 subjects with specific blood pressure ranges) for clinical validation. However, these specific details are not present 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)

For a blood pressure monitor, the "ground truth" (or reference measurement) is typically established by trained observers (often physicians or nurses) using a standardized auscultatory method, with the accuracy verified against a mercury sphygmomanometer or highly accurate validated electronic device.

The document does not specify the number of experts or their specific qualifications used to establish the ground truth for the clinical validation. ISO 81060-2 mandates specific procedures for reference measurements, involving two trained observers, but these details are not stated here.

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

The document does not describe any adjudication method for the test set. For clinical validation of blood pressure monitors, the ISO 81060-2 standard outlines a specific methodology for collecting simultaneous reference measurements from two trained observers, and if there are significant discrepancies, a third observer might be involved. However, this level of detail is not present in the provided text.

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 section is not applicable to this device. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.

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

The device is inherently a "standalone" automated measurement system. Its performance, as validated against ISO 81060-2, represents its algorithm-only performance in measuring blood pressure and pulse rate. The study is a standalone performance evaluation.

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

The ground truth for blood pressure measurement is established through:

• Simultaneous auscultatory measurements by trained observers using a reference sphygmomanometer (mercury or a highly accurate validated electronic device). This is the standard method prescribed by ISO 81060-2.

While the document doesn't explicitly state "auscultatory measurements," the reference to ISO 81060-2 implies this methodology for ground truth establishment.

8. The sample size for the training set

This device is a hardware product with embedded software/firmware for an established measurement principle (oscillometric). It is not an AI/ML device that undergoes "training" in the typical sense of a deep learning model. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no information on a training set size is provided.

9. How the ground truth for the training set was established

As explained above, there is no "training set" in the AI/ML context for this type of device. The accuracy of the device is assessed through clinical validation against established ground truth measurements from human observers, as per ISO 81060-2, not "trained" on a dataset.

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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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