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The Electronic 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.
The intended arm circumference includes 22 cm~32 cm.

The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHq 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. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document is a 510(k) summary for an Electronic Blood Pressure Monitor (Model: PG-800B30, etc.) from Shenzhen Pango Medical Electronics Co., Ltd. This document does not contain information about software algorithms for intelligent analysis or AI assistance. Therefore, it does not provide the details requested for acceptance criteria and study proving device performance for such AI-based systems.

The document discusses the substantial equivalence of the new device to a predicate device (K170151), focusing on non-clinical tests (electrical safety, EMC, software verification/validation, human factors/usability) and stating that no clinical measurement performance test was needed because the blood pressure measurement function, principle, and NIBP algorithm are identical to the legally marketed predicate device.

Specifically, the document lacks the following:

• Acceptance criteria table and reported device performance for an AI/ML algorithm. The "Accuracy" row in the comparison table refers to the device's accuracy for blood pressure measurement (3mmHg), not an AI algorithm's performance metrics.
• Sample size and data provenance for an AI test set.
• Number of experts and their qualifications used for ground truth establishment for an AI algorithm.
• Adjudication method for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance data.
• Type of ground truth used for an AI algorithm.
• Training set sample size for an AI algorithm.
• Method for establishing ground truth for an AI training set.

The document states that the device's software was considered a "Moderate" level of concern, and software verification and validation testing were conducted as per FDA guidance. However, this is for the device's core functionality (non-invasive blood pressure measurement using an oscillometric technique), not an AI-driven diagnostic or analytical tool.

In summary, this document is for a standard electronic blood pressure monitor, not a device incorporating a novel AI/ML algorithm that would require the detailed performance study and acceptance criteria you've asked for.

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The Electronic 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.

The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).

The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or Kpa.

The proposed electronic blood pressure monitor has eight models, including PG-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance.

The proposed device is intended to be used in medical facilities or at home.

The provided document is a 510(k) Summary for an Electronic Blood Pressure Monitor (K223291), seeking substantial equivalence to a predicate device (K161845). It includes information about non-clinical and clinical testing performed to demonstrate device performance and safety.

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

Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Electronic Blood Pressure Monitor are related to its accuracy in measuring blood pressure and pulse rate, and its compliance with relevant medical device standards.

Table 1: Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The document describes both non-clinical and clinical testing.

Clinical Testing (Performance Study)

The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2:2018 standard.

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

   • Sample Size: Not explicitly stated in the provided text. The ISO 81060-2 standard typically requires a minimum of 85 subjects with specific demographic balance (e.g., age, sex, arm circumference, and blood pressure distribution) for a full validation.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it is a clinical test for device validation, it is generally assumed to be prospective.

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

   • Not applicable for blood pressure monitor validation studies. Ground truth in such studies is typically established by simultaneous measurements using a validated reference method (e.g., auscultatory method by trained observers with a mercury sphygmomanometer) as per the ISO 81060-2 standard, not by expert consensus on images or data interpretation.

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

   • Not applicable as the ground truth is established by simultaneous reference measurements, not by expert interpretation requiring adjudication. ISO 81060-2 involves multiple trained observers for reference measurements.

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:

   • This is not an AI-assisted device for diagnostic interpretation; it is a direct measurement device. Therefore, an MRMC study is not relevant or applicable.

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

   • The "clinical test" is essentially the "standalone" performance of the device (algorithm and hardware combined) against a reference standard. The device operates automatically once initiated.

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

   • The ground truth for blood pressure monitor validation (as per ISO 81060-2) is established by simultaneous auscultatory measurements performed by trained observers using a validated reference method (e.g., mercury sphygmomanometer with a stethoscope). This is generally considered a highly reliable and direct physiological measurement.

7. The sample size for the training set:

   • This device is an Electronic Blood Pressure Monitor using an oscillometric technique, not a machine learning/AI model that typically requires a separate "training set" in the conventional sense. The "algorithm" for blood pressure calculation from oscillometric pulses is built into the device. Therefore, a distinct "training set" like those used for AI models is not applicable or specified.

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

   • Not applicable for the reason stated above. The underlying oscillometric principle and algorithms are well-established.

Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. These tests covered various aspects of safety and performance.

• Testing Standards:
  • ISO 10993-1:2018 (Biological evaluation - risk management)
  • ISO 10993-5:2009 (Cytotoxicity)
  • ISO 10993-10:2010 (Irritation and delayed-type hypersensitivity)
  • IEC 60601-1:2005 + A1:2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
  • IEC 60601-1-11:2015 (Home healthcare environment)
  • IEC 60601-1-2:2014 (EMC)
  • IEC 80601-2-30:2018 (Automated non-invasive sphygmomanometers)

The document concludes that the non-clinical tests and the clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.

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PG-IRT1612 & PG-IRT1618

Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment.

PG-IRT1613 & PG-IRT1615

Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages at home or in hospital environment.

The proposed device includes 4 models, which are PG-IRT1613, PG-IRT1613, PG-IRT1615 and PG-IRT1618. All models of infrared thermometers are intended for people of all age.

The proposed devices, Infrared Forehead Thermometers, Model PG-IRT1612 and PG-IRT1618, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring forehead. They are non-contact infrared thermometers. The distance of the measurement is 3~5cm.

The proposed devices, Infrared Ear/Forehead Thermometers, Model PG-IRT1613 and PG-IRT1615, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring ear canal or forehead. The ear cavity mode is contact measurement. The forehead mode is non-contact measurement and the measurement distance is 1~5mm.

The proposed devices are operated in adjusted mode. The body site used to reference the adjusted temperature value displayed on the proposed device of each model is oral.

Principle of operation

The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.

The provided text describes the acceptance criteria and a clinical study conducted for the Shenzhen Pango Medical Electronics Co., Ltd. Infrared Thermometers (Models: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the infrared thermometers are primarily based on the standards ISO 80601-2-56 and ASTM E1965-98. The reported device performance indicates compliance with these standards.

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

• Sample Size (Clinical Study): A total of 120 subjects were used for each clinical study, split into three age groups:
  • Age 0-1: 40 subjects
  • Age 1-5: 40 subjects
  • Age above 5: 40 subjects
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It does state that "Controlled human clinical studies were conducted in accordance with ASTM E1965-98 (Reapproved 2016)," but the location of these studies is not specified. It is likely a prospective study as it involved actively recruiting subjects to test the device.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

No information about a Multi Reader Multi Case (MRMC) comparative effectiveness study is provided in the document. The study was a comparison to a predicate device's performance, not specifically focusing on human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, the clinical study performed can be considered a standalone performance study for the algorithm embedded within the device, as it evaluates the device's accuracy, bias, and repeatability against established clinical standards (ASTM E1965-98). The device itself is an "algorithm only" in the sense that it automatically calculates and displays temperature based on sensor readings without human interpretation of raw data.

7. Type of Ground Truth Used

The ground truth for the clinical study was established by comparison with a predicate device and compliance with standardized clinical validation methods (ASTM E1965-98). While not explicitly stated as "expert consensus" or "pathology," the ASTM E1965-98 standard defines methods for clinical accuracy assessment of intermittent thermometers, which usually involves comparing the device's readings to highly accurate reference thermometers or established clinical methods as the ground truth. The statement that "febrile persons" were included implies that actual body temperatures, including elevated ones, were measured.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This type of device (infrared thermometer) typically relies on engineering calibration and validation against physical standards and clinical studies rather than machine learning training sets in the AI sense.

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

As no training set is mentioned for this device, a method for establishing its ground truth is also not applicable or not provided. The development process likely involves engineering design, component selection, calibration, and then validation through the non-clinical and clinical tests described.

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