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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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The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.

The Arm Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa.

The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low.

The FDA 510(k) clearance letter for the Arm Blood Pressure Monitor does not explicitly state acceptance criteria in a quantitative table or the specific performance metrics achieved in a typical "device performance" section as one might expect for a software-based or diagnostic device. Instead, it refers to compliance with established medical device standards, particularly ISO 81060-2:2018 (and its amendment from 2020) for clinical accuracy.

However, based on the context of the clinical data and the requirements of ISO 81060-2, we can infer the acceptance criteria for accuracy.

Here's a breakdown of the requested information based on the provided document:

Implied Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated by its adherence to the clinical accuracy requirements of ISO 81060-2 Third edition 2018-11 (including AMD1:2020).

Implied Acceptance Criteria of ISO 81060-2:2018 (and AMD1:2020):

The ISO 81060-2 standard consists of two parts for accuracy assessment:

• Criterion 1 (Mean Difference and Standard Deviation):
  • The mean difference between the device and the reference measurement for both systolic and diastolic blood pressure shall be $\leq \pm 5$ mmHg.
  • The standard deviation of these differences shall be $\leq 8$ mmHg.
• Criterion 2 (Cumulative Percentage of Differences):
  • For each subject, the absolute difference between the device and the reference measurement should be calculated.
  • The cumulative percentage of devices should have absolute differences within certain thresholds:
    • $\leq 5$ mmHg for at least 65% of measurements.
    • $\leq 10$ mmHg for at least 85% of measurements.
    • $\leq 15$ mmHg for at least 95% of measurements.

Table of Acceptance Criteria and Reported Device Performance (Inferred from ISO 81060-2)

Note: The document explicitly states, "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2 Third edition 2018-11 [Including AMD1:2020]." This confirms the device met the numerical precision requirements of the standard for mean difference and standard deviation. While it doesn't provide the exact numbers for each group, it confirms compliance with the key statistical thresholds.

Study Details

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

   • Total Sample Size: The 28 models were grouped into 7 categories for clinical accuracy testing. Each of these 7 groups had a test set of 100 subjects, except for Group 7, which had 92 subjects.
     • Group 1: 100 subjects
     • Group 2: 100 subjects
     • Group 3: 100 subjects
     • Group 4: 100 subjects
     • Group 5: 100 subjects
     • Group 6: 100 subjects
     • Group 7: 92 subjects
   • Male/Female Distribution: Each group had a participant distribution of at least 30% male and at least 30% female.
   • Age Range: Subjects were "adult person" with an age range of "> 12 years old," specifically noted ranges from 15 to 80 years old across the groups.
   • Data Provenance: The document does not explicitly state the country of origin for the clinical data. It also does not explicitly state if the study was retrospective or prospective, but clinical accuracy studies adhering to ISO 81060-2 are typically prospective and involve simultaneous, sequential measurements.

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

   • The document does not specify the number or qualifications of experts (e.g., radiologists) for establishing ground truth in this context. For blood pressure monitors, "ground truth" is typically established by trained technicians or clinicians using a validated reference method (e.g., mercury sphygmomanometer) following a rigorous protocol (like the auscultatory method per ISO 81060-2). The standard requires independent observers for reference measurements.

3. Adjudication Method for the Test Set:

   • The document states, "The clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2 Third edition 2018-11 [Including AMD1:2020]. The Same Arm Sequential Method was chosen for all studies."
   • ISO 81060-2 outlines a specific method for ground truth establishment for blood pressure. It typically involves multiple independent observers (at least two trained observers) who simultaneously or sequentially measure blood pressure using a validated reference device. Discrepancies between these observers are resolved in accordance with the standard, which usually involves specific rules for averaging or discarding measurements based on predefined variability criteria, rather than a formal "adjudication panel" in the sense of image interpretation.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. For a non-invasive blood pressure monitor, the study focus is on the device's measurement accuracy against a reference standard, not on how it assists human interpretation.

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

   • Yes, in essence, a "standalone" or "algorithm only" performance was evaluated. The device (Arm Blood Pressure Monitor) is an automated system that measures blood pressure. Its clinical accuracy study measures its direct output (systolic and diastolic pressure) against a reference standard. There isn't a "human-in-the-loop" component in the operational measurement process that would affect its core accuracy, as it's an automated device.

6. The Type of Ground Truth Used:

   • The ground truth was established by comparison with a validated reference measurement method, as prescribed by ISO 81060-2. This typically involves the auscultatory method using a mercury sphygmomanometer or an equivalent validated reference device, with measurements performed by trained observers.

7. The Sample Size for the Training Set:

   • Not applicable / Not provided. This device is a hardware-based blood pressure monitor that uses an oscillometric technique and a "blood pressure core algorithm." It is not described as a machine learning or AI algorithm that requires a separate "training set" in the conventional sense of deep learning. Its performance is based on its engineering design and the embedded validated algorithm.

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

   • Not applicable / Not provided. As mentioned above, there isn't a "training set" in the common understanding for a typical medical AI device. The core algorithm is likely developed and validated internally by the manufacturer through engineering principles and extensive testing, not necessarily through a separate clinical "training set" with ground truth in the AI context. The clinical data presented is for validation (test set) of the final device, demonstrating its accuracy.

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The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.

Arm blood pressure monitor, models(models ARM-30H, ARM-30J, ARM-30K and AOJ-90B), are designed as a battery driven automatic no-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. All the models included in this submission follow the similar software, same measurement principle and same specifications. All the models can be used with one cuff size 2242 cm (8.616.5 inches). AOJ90B has extra 4G network except for other models.

Here's an analysis of the provided FDA 510(k) clearance letter to extract information on acceptance criteria and the study proving device performance:

Summary of Device and Context:

The submission K250116 concerns several models of Arm Blood Pressure Monitors (ARM-30H, ARM-30J, ARM-30K, ARM-90B) manufactured by Shenzhen AOJ Medical Technology Co., Ltd. These devices are intended for non-invasive oscillometric measurement of systolic and diastolic blood pressure and pulse rate in adults, for both medical facilities and home use. The predicate device is the Arm Blood Pressure Monitor, model AOJ-30B (K222125).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set (Clinical Studies)

• Clinical Study for ARM-90B:

  • Sample Size: 100 adult subjects (61 females, 39 males)
  • Age Range: 19 to 77 years
  • Data Provenance: Not explicitly stated (e.g., country of origin). Since Shenzhen AOJ Medical Technology Co., Ltd. is based in China, it's highly probable the study was conducted there, but this is not confirmed in the provided text. The study method was prospective, as subjects were enrolled for the purpose of the study.

• Clinical Study for ARM-30H:

  • Sample Size: 100 adult subjects (54 females, 46 males)
  • Age Range: 18 to 80 years
  • Data Provenance: Not explicitly stated. Likely prospective, similar to ARM-90B.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For blood pressure monitor clinical studies, ground truth is typically established by trained technicians or clinicians using validated reference devices, but the specific details are not present.

4. Adjudication Method for Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1). For blood pressure studies following ISO 81060-2, the ground truth measurements are usually taken by trained observers using mercury sphygmomanometers or other validated reference methods. The standard itself outlines the procedures for taking these measurements, which inherently involves multiple measurements and comparisons, but not necessarily a formal adjudication process in the sense of resolving conflicting interpretations of images or complex diagnostic results. The "Same Arm Sequential Method" was chosen for both studies, indicating a direct comparison of the device's readings against reference readings on the same arm of the subject.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done.
This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers are making diagnoses. For a blood pressure monitor, the device provides a direct measurement, not an interpretation that a human would then refine. The clinical studies directly evaluate the device's accuracy against a recognized reference standard.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done for the device. The clinical studies performed according to ISO 81060-2 directly assess the performance of the device itself (the algorithm within the device) against a reference standard without human intervention in interpreting the device's output. The device is the algorithm in this context, automatically performing inflation, deflation, and measurement.

7. Type of Ground Truth Used

The ground truth used for the clinical studies was established by comparison with a reference method defined by ISO 81060-2. This standard outlines precise procedures for obtaining reference blood pressure measurements (typically using a mercury sphygmomanometer or other validated reference devices operated by trained observers) against which the automated device's readings are compared. The criteria state "mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2," which implies the ground truth is based on reference measurements adhering to this international standard.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set.
510(k) submissions typically focus on the performance of the final device, not the details of its development or training data for its internal algorithms, unless the device explicitly uses machine learning algorithms that are updated or adapt. For a standard oscillometric blood pressure monitor, the algorithm is generally fixed and designed based on established physiological principles and extensive validation, rather than being "trained" on a dataset in the modern sense of machine learning.

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

As with the training set sample size, the document does not provide information on how the ground truth for any potential training set was established. Given the nature of a blood pressure monitor, the "training" (if it occurs in a machine learning context) would likely involve extensive data collection with reference ground truth from validated sphygmomanometers, similar to the clinical validation studies, but specifically for internal algorithm development and refinement. However, this is speculative as the document does not detail the development process.

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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.

The Arm Blood Pressure Monitor, including XY-B01, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference of 220-320mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The Arm Blood Pressure Monitor is composed of monitor unit and arm cuff. Of which, the main unit contains main control circuit board, air pump, deflation valve, LCD and shell. The seven models have the same intended use, working principle, measuring range, cuff, and conformance standard, except for appearance and power supply. The devices are powered by 4AA batteries (XY-B02) or 4AAA batteries (other models). The Arm Blood Pressure Monitor has a memory function that automatically stores 2*60 sets data of the latest measurements.

Based on the provided FDA 510(k) summary for the Arm Blood Pressure Monitor (XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09), here's a description of the acceptance criteria and the study that proves the device meets them:

Device: Arm Blood Pressure Monitor (XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
Purpose: Noninvasive Blood Pressure Measurement System

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the primary acceptance criteria are based on recognized international standards for non-invasive blood pressure monitors, specifically ISO 81060-2:2018 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers). The acceptance criteria and the device's performance against them are:

Additionally, the device must comply with several other non-clinical standards for safety and performance:

• IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
• IEC 60601-1-11:2015 (Requirements for medical electrical equipment and systems used in the home healthcare environment)
• IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
• ISO 10993-10:2010 (Biological evaluation - irritation and skin sensitization)
• ISO 10993-5:2009 (Biological evaluation - in vitro cytotoxicity)

The "Performance Data" section states that the Arm Blood Pressure Monitor "comply with" these standards, indicating they met the acceptance criteria for these non-clinical aspects.

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

• Sample Size: 120 subjects (55 female and 65 male).
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective or Prospective: The study was a prospective clinical test conducted to verify compliance with ISO 81060-2:2018.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test data. For blood pressure clinical validation studies following ISO 81060-2, ground truth is typically established by trained and certified medical professionals (e.g., physicians, nurses) using a reference sphygmomanometer (mercury sphygmomanometer or highly accurate oscillometric device) in a strict protocol.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. For blood pressure validation, ground truth readings are often taken by multiple observers, and the average or a specific methodology is used to minimize observer bias, but this is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this type of study was not conducted. This device is a standalone measurement device, not an AI-assisted diagnostic tool where human readers assess cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical test described is essentially a standalone performance validation of the device's measurement algorithm. The study validates the accuracy of the device itself (analogous to "algorithm only" in this context) against a known reference standard, without human interpretation of complex outputs beyond reading the blood pressure values.

7. The Type of Ground Truth Used

The ground truth for the accuracy validation was established through comparison with reference measurements taken from the 120 subjects. This is standard for blood pressure device validation, where the device's readings are compared against simultaneously obtained, highly accurate reference blood pressure measurements (e.g., using a auscultatory method with a mercury sphygmomanometer or another validated reference device). The summary explicitly states the test was conducted to verify that the proposed device met the requirements of ISO 81060-2:2018, which outlines the methodology for establishing this ground truth.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" because this device is a hardware medical device with an embedded algorithm for blood pressure measurement, rather than a machine learning model developed with a distinct training and test dataset. The performance "training" (i.e., design and calibration) is part of the engineering and manufacturing process, and the clinical test is the validation of the final product's performance.

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

As noted above, there isn't a "training set" in the sense of a machine learning dataset. The "ground truth" used during the device's development, calibration, and internal testing phases would have been established through a rigorous process of clinical measurements and calibration against reference standards in a controlled environment, consistent with the principles of blood pressure measurement accuracy outlined in relevant standards.

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Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.

Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm33cm and cuff of size 33cm47cm.

The provided text describes a 510(k) submission for an Arm Blood Pressure Monitor (model: BPM-A7VL). This is a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are primarily focused on its clinical accuracy, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and software performance.

Here's a breakdown based on the provided information:

Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2 and IEC 80601-2-30. The text explicitly states that the device's performance complies with these standards.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

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

   • Sample Size: 85 subjects were used for the clinical accuracy test.
   • Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2," implying a formal clinical study. The submission is from Shenzhen IMDK Medical Technology Co., Ltd. (China), so it's highly probable the study was conducted retrospectively or prospectively in China, but this is not definitively stated. The study type is prospective clinical accuracy testing, as it involves a concurrent comparison with a reference standard.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The clinical accuracy testing for blood pressure monitors, as per ISO 81060-2, typically involves a comparison against a reference method (usually auscultatory measurements using a mercury or aneroid sphygmomanometer by trained observers). The document mentions "Aneroid sphygmomanometer" and "Measuring Method: Aneroid/auscultation method" as the reference equipment.
   • ISO 81060-2 requires at least two trained observers (experts) to simultaneously and independently measure blood pressure using the reference method, usually blinded to each other's readings and the device's readings. The document does not explicitly state the number or qualifications of these observers, but their involvement is a fundamental requirement for ISO 81060-2 compliance. They would be healthcare professionals (e.g., physicians, nurses, technicians) specially trained and certified for accurate auscultatory blood pressure measurement.

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

   • For ISO 81060-2, the standard adjudication method typically involves the simultaneous independent measurements by two trained observers. If their readings differ by a certain threshold (e.g., > 4 mmHg), a third observer or a consensus reading might be involved for specific cases, or those readings might be discarded. The document does not detail the exact adjudication criteria but implies adherence to the ISO standard.

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 document is for a non-invasive blood pressure monitor, which is a physical measurement device, not an AI-assisted diagnostic imaging tool where MRMC studies are typically performed. The "AI" component mentioned refers to the automated measurement algorithm within the device, not a separate AI for interpretation assistance to human readers.

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

   • Yes, in essence, standalone performance was evaluated. The clinical accuracy study evaluates the device's (algorithm's) ability to accurately measure blood pressure independently of direct human interpretation, comparing its output directly against a highly accurate reference standard. The device itself is "standalone" in its measurement function.

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

   • The ground truth for the clinical accuracy study was established using expert auscultatory measurements (performed by trained observers) from a validated reference device (Aneroid sphygmomanometer, Model: CM-BPM-D, K211084), following the methodology prescribed by ISO 81060-2.

7. The sample size for the training set:

   • Not applicable / Not specified. This submission is for a medical device that uses an oscillometric measurement principle and internal algorithms. It is not an AI/ML device that typically undergoes explicit "training" on a separate dataset in the same way as, for example, an image classification model. The software component mentioned underwent "verification and validation," which implies testing against requirements and design specifications, not training on a dataset. The algorithms are likely fixed based on established oscillometric principles.

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

   • Not applicable. As explained above, there isn't a "training set" in the context of an AI/ML model for this type of device. The ground truth for the performance verification (clinical accuracy testing) was established via expert auscultatory measurements against a reference device, as detailed above.

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The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Not Found

I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for an Arm Blood Pressure Monitor. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain any information about acceptance criteria, device performance details, or a study proving that the device meets acceptance criteria.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, data provenance, or details about ground truth establishment.
• Information on expert involvement, adjudication methods, or MRMC studies.
• Any data related to standalone algorithm performance.

Therefore, I cannot extract the requested information from the provided input.

Ask a specific question about this device

The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.

Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.

Based on the provided FDA 510(k) clearance letter for the Alicn Medical Shenzhen, Inc. Arm Blood Pressure Monitor, I cannot extract the specific details requested regarding acceptance criteria and study data because this document does not contain that information.

The FDA 510(k) clearance letter is a regulatory document that confirms substantial equivalence to a predicate device. It indicates that the device has met the FDA's requirements for marketing, but it typically does not include the granular details of the performance study results, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. These details are usually found in the manufacturer's 510(k) submission, which is not publicly available in this letter.

Therefore, many of your questions, particularly those related to the study design and results (points 1-9), cannot be answered from the provided text.

Here's what I can tell you based on the document:

• Device: Arm Blood Pressure Monitor, Model: AES-U112, AES-U122, AES-U132, AES-U312, AES-U322, and AES-U332.
• Intended Use: To measure systolic blood pressure and pulse rate via non-invasive oscillometric technique using an inflatable cuff on the upper arm. Can be used at medical facilities or at home. Suitable for adults and adolescents over 12, with an upper arm circumference of 22-42cm.
• Regulatory Class: Class II
• Product Code: DXN (Noninvasive Blood Pressure Measurement System)

Regarding your specific questions, and why I cannot answer them from this document:

1. A table of acceptance criteria and the reported device performance: This information is not in the FDA clearance letter. It would be in the manufacturer's internal test reports and the 510(k) submission.
2. Sample sized used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
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 is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm; this is a direct measurement device. Its performance is its "standalone" performance. The specific study details are not here.
7. The type of ground truth used: Not specified in this document, but for blood pressure monitors, ground truth is typically established against a reference method, such as invasive arterial pressure measurement or a highly accurate auscultatory method performed by trained observers.
8. The sample size for the training set: Not applicable and not mentioned. This device likely relies on a fixed algorithm based on oscillometric principles, not machine learning (training sets).
9. How the ground truth for the training set was established: Not applicable for this type of device.

To obtain the detailed study information, one would typically need to refer to the full 510(k) submission (which is proprietary and not released publicly with the clearance letter) or a published clinical validation study by the manufacturer, if available.

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The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.

AOJ-33series arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device. AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.

The provided text describes the acceptance criteria and the study that proves the Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B, meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. The document states that the device was tested to ISO 81060-2:2018.

2. Sample size used for the test set and the data provenance

• Sample Size: 100 adult subjects (49 female, 51 male).
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a clinical validation study performed on AOJ-33A, implying it was a prospective study conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document refers to a "Same Arm Sequential Method" clinical validation study in accordance with ISO 81060-2:2018. This standard typically involves multiple trained observers (experts) taking sequential measurements using a reference sphygmomanometer. However, the document does not specify the exact number of experts or their qualifications.

4. Adjudication method for the test set

The document states "The Same Arm Sequential Method was chosen." This method, as described in ISO 81060-2, involves comparing the automated device measurements to those taken by trained observers using a reference manual sphygmomanometer on the same arm. While it implies a comparison against expert readings, the document does not explicitly detail an adjudication method (e.g., 2+1, 3+1). The standard outlines procedures for obtaining reference measurements, which inherently involve a form of expert consensus or highly standardized measurement to establish ground truth.

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 question is not applicable as the device is an automated blood pressure monitor and not an AI-assisted diagnostic tool for human readers. It directly measures and displays blood pressure and pulse rate.

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

Yes, a standalone performance evaluation was done. The clinical validation study described is for the device (AOJ-33A) functioning independently to measure blood pressure and pulse rate, without human interpretation or assistance during the measurement process.

7. The type of ground truth used

The ground truth for the clinical study was established by comparison with established reference measurements, likely from a manual sphygmomanometer operated by trained observers, as per the ISO 81060-2:2018 standard for non-invasive sphygmomanometers. This effectively represents a validated, expert-derived measurement.

8. The sample size for the training set

The document does not specify a separate training set sample size. The clinical data mentioned (100 adult subjects) refers to the testing or validation set for the device's performance against the standard. For medical devices like blood pressure monitors, the "training" (i.e., calibration and algorithm development) often occurs internally during the device design phase, and explicit "training set" data for regulatory submission in the same way as an AI algorithm is typically not detailed.

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

As there is no explicit mention of a separate "training set" in the context of data for regulatory submission (beyond the device's inherent design and calibration), this information is not provided in the document. The general principle for developing such devices involves engineering and clinical testing to ensure accurate readings, which implicitly leverages previous data and established hemodynamic principles to calibrate the oscillometric algorithm.

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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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