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Venen-trainer (Model: FM150, SFM90) is intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. These devices are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Venen-Trainer (model: FM150, SFM90) is a compression therapy device, consists of two leg cuffs with integrated inflation and deflation air cushions, two air hoses and a handheld controller. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body. Squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly. The two leg cuffs are each connected to one end of an air hose, and the other end of the two air hoses is connected to the controller. The air pressure controller has a built-in vacuum pump, and the air pressure intensity can be adjusted by the air pressure controller. Turn the knob clockwise to increase the intensity. The timer of FM150 can be switched between three timings of 10 minutes, 20 minutes, and the timer of SFM90 is only one timing of 30 minutes. The two leg cuffs are inflated alternately and will not be inflated simultaneously. In addition, there are hook and loop buckles on the foot cover to adjust the leg cuff to the shape of user's leg.

This document is a 510(k) summary for the Venen-trainer (Model: FM150, SFM90), a compression therapy device. The submission aims to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in the typical format of a table with specific metrics (e.g., sensitivity, specificity, accuracy) and corresponding thresholds for device performance. Instead, the "acceptance criteria" are implied by the demonstration of conformity to established medical device standards and functional equivalence to the predicate device. The device performance is primarily assessed through a series of lab bench tests.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

1. Sample sizes used for the test set and data provenance:
   The document describes "lab bench testing" for electrical safety, EMC, biocompatibility, and software verification and validation. It does not mention a "test set" in the context of clinical or performance data involving human subjects or specific diagnostic outputs that would require a sample size. The testing appears to be hardware and software validation against technical standards. Therefore, information about sample size, country of origin, or retrospective/prospective nature is not applicable in this context.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   This information is not applicable as the document does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The testing performed is related to compliance with engineering and safety standards.

3. Adjudication method for the test set:
   This information is not applicable as there is no mention of a test set requiring adjudication in the context of diagnostic performance or clinical outcomes.

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 information is not applicable. The device described is a physical compression therapy device, not an AI-assisted diagnostic or therapeutic system involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is not an algorithm-only system. Its performance is assessed as a medical device against safety and performance standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the technical tests (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international and FDA standards (e.g., IEC 60601-1, ISO 10993) and the manufacturer's own design specifications. There is no biological or clinical "ground truth" established from patients or pathology in this submission.

7. The sample size for the training set:
   This information is not applicable. The device is not an AI/ML device that requires a training set of data.

8. How the ground truth for the training set was established:
   This information is not applicable for the same reason as point 7.

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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. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 cm and 32 cm42 cm.

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 adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: 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. It has a bar indicating function, which can indicate the World Health Organization (WHO) 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 six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.

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

The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided document describes the FDA 510(k) premarket notification for an Electronic Blood Pressure Monitor (K200716).

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a separate section, but it does list specifications the device claims to meet, which serve as acceptance criteria. The device's reported performance is directly stated as meeting these specifications or being identical to the predicate device.

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 explicitly states: "No Clinical study is included in this submission" for the proposed device (K200716). Therefore, there is no sample size for a test set, nor data provenance information for a clinical study of this specific device.

The basis for proving substantial equivalence to the predicate device (K170151) is that the blood pressure measurement function, including the measurement principle and NIBP algorithm, and cuff size are identical. The predicate device did conduct a clinical study according to ISO 81060-2 (as noted in the comparison table), but the details of that study (sample size, provenance) are not provided in this document.

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)

Since no clinical study was conducted for the proposed device (K200716), there were no experts used to establish ground truth for a test set for this submission.

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

Not applicable, as no clinical study was conducted for the proposed device.

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. The device is an automated blood pressure monitor and does not involve AI assistance for human readers/operators in its primary function of blood pressure measurement.

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

For the proposed device (K200716), a standalone performance evaluation in a clinical setting was not done. Its performance is asserted as identical to the predicate device (K170151) due to shared measurement principles and algorithms.

Non-clinical tests were conducted to verify design specifications and compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 62133), which can be considered "standalone" technical evaluations.

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

For the proposed device (K200716) submission, no new clinical ground truth was established. The submission relies on the ground truth established by the predicate device's clinical study (which was "conducted according to ISO 81060-2"). ISO 81060-2 defines the clinical investigation of non-invasive sphygmomanometers, which typically involves comparing the device's readings against a reference measurement (e.g., auscultatory method performed by trained observers).

8. The sample size for the training set

Not applicable. There is no mention of a training set for a machine learning model, as this is an automated blood pressure monitor based on an established oscillometric algorithm, not an AI/ML-based diagnostic device in the context of typical training sets. The comparison focuses on the measurement algorithm being identical to the predicate.

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

Not applicable, as there is no training set mentioned or implied for this device.

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PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 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.

The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age.

The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal.

The proposed device, Infrared Skin Thermometers, Model PG-IRT1602, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 3cm~5cm.

The proposed device, Infrared Ear/Forehead Thermometer, Model PG-IRT1603, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal or forehead. The distance of the measurement is 3~5cm while measuring the forehead temperature.

The provided document is a 510(k) Summary for an Infrared Thermometer. It describes the device's indications for use, design, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria and study results in the format requested. Specifically, it talks about clinical and non-clinical tests verifying compliance with standards like ASTM E1965-98, but it does not provide:

• A table of specific numerical acceptance criteria for performance metrics (e.g., accuracy +/- X degrees C) and the reported device performance against those specific criteria.
• The exact sample size used for the test set in the clinical study (it states 130 subjects for each clinical study, implying 3 studies for the 3 models, but doesn't break down by test set vs. training set or specific age groups for overall "clinical study" rather than a dedicated "test set").
• Data provenance beyond "clinical trial results."
• Details on expert involvement, ground truth establishment methods (beyond "clinical validation"), or adjudication methods.
• Any information regarding MRMC studies, standalone AI performance, or training set details.

The document focuses on demonstrating compliance with recognized standards and similarity to predicate devices, rather than providing raw performance data against predefined acceptance criteria for a novel AI/algorithm. This is typical for a 510(k) submission for a non-AI medical device like a thermometer, where compliance with performance standards and safety is key for substantial equivalence.

Therefore, I cannot provide the information in the requested format based on the text provided. The document is a regulatory submission for a simple medical device (infrared thermometer), not an AI algorithm.

If this were a submission for an AI/ML device, the content would have to include the specific details you've asked for because the performance evaluation of AI is very different from that of a basic electronic thermometer.

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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. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 cm and 32 cm42 cm.

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 adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: 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. 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 12 models, including PG-800B22, PG-800B23, PG-800B26, PG-800B27, PG-800B31, PG-800B32, PG-800B33, PG-800B35, PG-800B36, PG-800B37, PG-800B42 and PG-800B43. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.

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

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 the "Electronic Blood Pressure Monitor" by Shenzhen Pango Electronic Co., Ltd. It declares substantial equivalence to a predicate device. However, this document primarily focuses on regulatory compliance, outlining intended use, device description, comparison to a predicate, and non-clinical test conclusions based on various IEC standards.

Crucially, this document does NOT contain information about a clinical study involving a test set, expert readers, ground truth establishment, or any data related to diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for a typical AI/ML medical device submission.

Instead, the performance of this blood pressure monitor is assessed against standards for accuracy defined by organizations like ISO and IEC for non-invasive sphygmomanometers. Therefore, the "acceptance criteria" and "proof of meeting criteria" here refer to the device's ability to measure blood pressure within the specified accuracy limits of these standards, not against a human expert consensus.

Given this, I will interpret the requested information in the context of a blood pressure monitor's accuracy testing, as implied by the reference to IEC 80601-2-30:2009 and ISO 81060-2:2013 (which generally address accuracy requirements for automated sphygmomanometers).

Based on the provided document, here's an attempt to answer your questions, with the understanding that the "study" is likely a performance verification against a standard, not a clinical trial with human readers assisting AI.

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

The document states that the device "Comply with IEC 80601-2-30:2009 and ISO 81060-2:2013" for "Particular Performance." These standards define the accuracy requirements for automated non-invasive sphygmomanometers.

Acceptance Criteria (as per ISO 81060-2:2013 for clinical validation for blood pressure devices):

The ISO 81060-2:2013 standard typically requires two main criteria for accuracy:

• Mean difference: The mean difference between the device's measurement and the reference standard (e.g., mercury sphygmomanometer) should be $\le \pm 5$ mmHg.
• Standard deviation: The standard deviation of the difference between the device's measurement and the reference standard should be $\le 8$ mmHg.
• Individual differences (AAMI/BHS protocols often append this): A high percentage of measurements (e.g., >60% for AAMI, or various grades for BHS) must fall within certain error margins (e.g., $\pm 5, \pm 10, \pm 15$ mmHg).

Reported Device Performance:

The document states: "The test results demonstrated that the proposed device complies with the following standards: ... IEC 80601-2-30:2009, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers" and "Comply with IEC 80601-2-30:2009 and ISO 81060-2:2013".

Therefore, the reported device performance is that it met the accuracy requirements outlined in these standards. The specific numerical values (mean difference and standard deviation) are not provided in this 510(k) summary, but the declaration of compliance serves as the proof.

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 specify the sample size for the accuracy testing. ISO 81060-2:2013 typically recommends a minimum of 85 participants for a clinical validation study to assess accuracy. The data provenance (country of origin, retrospective/prospective) is also not disclosed in this summary. Such details would usually be found in the full test report, not the 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)

This is not applicable in the context of a blood pressure monitor's accuracy testing. The "ground truth" for blood pressure measurements is typically established by simultaneous measurements using a reference standard device, often a double-headed mercury sphygmomanometer, read by trained observers, not "experts" in the sense of medical specialists adjudicating an image.

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

Not applicable. Blood pressure accuracy testing does not involve adjudication of readings in the typical sense of expert consensus on an image or medical condition. Instead, it involves comparison to standard reference measurements.

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 automatic blood pressure monitor, not an AI-assisted diagnostic tool that human readers would use. There is no human-in-the-loop component or AI assistance for interpretation.

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

Yes, the fundamental performance assessment of an automated blood pressure monitor is a standalone performance evaluation. The device (algorithm and hardware) measures blood pressure and provides a reading without human intervention in the measurement process. The "standalone" performance here refers to its accuracy against a reference standard. The document confirms that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards."

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

For blood pressure monitor accuracy, the ground truth is established by simultaneous, direct comparison to a validated reference measurement method, typically a mercury sphygmomanometer or an equivalent standard, performed by two trained observers. It is a live physiological measurement, not an static image or pathology result.

8. The sample size for the training set

This device does not appear to be an AI/ML model that undergoes "training" in the conventional sense of deep learning. It uses an "oscillometric technique" and an "NIBP algorithm" (Non-Invasive Blood Pressure algorithm). While such algorithms might be refined and calibrated, the concept of a "training set" as understood in modern AI/ML development (with vast amounts of labeled data) is not explicitly stated or implied by the document for this device. It's more of a calibration and validation process against physical principles and existing data.

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

As there's no explicitly mentioned "training set" in the AI/ML sense, this question isn't directly applicable. The underlying algorithm would have been developed based on general principles of oscillometry and vast amounts of existing physiological data, where the "ground truth" would originate from reference blood pressure measurements across diverse populations.

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The Electronic Blood Pressure Monitor is intended to measure the systolic 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

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 adult 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-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A36 and PG-800A37. 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 text describes the 510(k) summary for the "Electronic Blood Pressure Monitor" (multiple models: PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, PG-800A36, PG-800A37) by Shenzhen Pango Electronic Co., Ltd. The document aims to demonstrate substantial equivalence to a predicate device (PG-800A Series Electronic Blood Pressure Monitor, Models PG-800A5, PG-800A5D, K131569).

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed against recognized standards for non-invasive sphygmomanometers. The document states compliance rather than providing specific numerical results for each criterion explicitly in a performance table. However, it specifically references ISO 81060-2:2013 for clinical validation.

It's important to note that while the document states "Complies," the specific numerical acceptance criteria (e.g., mean difference and standard deviation from reference measurements for blood pressure, as specified in ISO 81060-2) are not provided in this excerpt. The "Complies" statement indicates the device met these criteria.

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

The document states compliance with ISO 81060-2:2013, which outlines requirements for clinical validation. While the exact sample size for the test set is not explicitly stated in this summary, ISO 81060-2:2013 typically requires a minimum of 85 subjects for clinical validation studies for automated non-invasive sphygmomanometers.

The data provenance (country of origin, retrospective/prospective) is not specified in this summary. It only indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

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

For clinical validation as per ISO 81060-2, blood pressure measurements are typically taken by trained observers using a mercury sphygmomanometer or auscultatory method simultaneously or sequentially with the device under test. The standard specifies requirements for these observers, including training and demonstration of accuracy.

The number of experts/observers and their specific qualifications are not explicitly stated in this excerpt. However, it can be inferred that trained personnel, likely medical professionals, would have been involved to establish the reference measurements as per the ISO standard requirements.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method for the test set. In clinical validation studies for blood pressure monitors, the "ground truth" measurements from trained observers are generally considered the reference, and the device's readings are compared against these. There isn't typically an adjudication process in the same way as, for example, for image-based diagnostic systems.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This is a blood pressure monitor, not an AI-assisted diagnostic tool that relies on human readers interpreting cases.

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

The device is an "Electronic Blood Pressure Monitor" and measures blood pressure via an "oscillometric technique." This is inherently a standalone algorithm-only (without human-in-the-loop performance for the measurement itself) device. The algorithm processes the oscillometric signals to determine blood pressure. User interaction is for initiating the measurement and reading the displayed results. The clinical validation in ISO 81060-2 is precisely this – comparing the automated device's output against reference measurements.

7. The Type of Ground Truth Used

The ground truth used for relevant performance criteria (specifically, clinical validation) would be reference blood pressure measurements obtained by trained observers using a validated method (e.g., auscultatory method with a mercury sphygmomanometer or other validated reference device) in accordance with the ISO 81060-2:2013 standard.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For oscillometric blood pressure monitors, the core algorithm for blood pressure determination is typically developed and refined using internal data and engineering principles during the R&D phase. The information provided focuses on the validation against standards.

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

The document does not provide details on how the ground truth for any training set was established. This information is usually proprietary to the manufacturer's R&D process for algorithm development and is not typically included in FDA 510(k) summaries, which focus on compliance with recognized standards for safety and effectiveness.

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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. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

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

All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

The provided text describes the 510(k) summary for an Electronic Blood Pressure Monitor (K131558). However, it focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant standards rather than detailing a specific clinical study with granular data on acceptance criteria and study design as requested.

Based on the provided information, I can extract the following:

1. Table of acceptance criteria and the reported device performance

Note: The text states, "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... AAMI SP10:2002/(R) 2008 & A1:2003, Manual, electronic or automated sphygmomanometers."
This implies that the device achieved the accuracy requirements outlined in AAMI SP10. The value of ± 3 mmHg is explicitly listed under "BP Accuracy" in the Substantial Equivalence comparison table, indicating it's the target and achieved accuracy.

Regarding other requested information:

• 2. Sample size used for the test set and the data provenance: Not specified in the provided text. The text only mentions "bench tests."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Clinical expert involvement is not mentioned for accuracy testing.
• 4. Adjudication method for the test set: Not specified.
• 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 a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the accuracy testing for the blood pressure monitor itself is a standalone test of its algorithm and hardware performance.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy is typically established by comparing the device readings against a validated reference method, often auscultation by trained observers using a mercury sphygmomanometer, as outlined in standards like AAMI SP10. While not explicitly stated as "ground truth method," compliance with AAMI SP10 implies this type of reference measurement.
• 8. The sample size for the training set: Not applicable/Not specified. This device likely uses a deterministic algorithm based on oscillometric principles, not a machine learning model requiring a distinct "training set" in the common sense. Calibration during manufacturing takes place, but this is different from a data-driven training set.
• 9. How the ground truth for the training set was established: Not applicable/Not specified for the reasons above.

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The PG-800A Series 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 proposed device, PG-800A Series Electronic Blood Pressure Monitor, is a battery driven automatic on-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 wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance and data storage. These two differences will not affect the safety and effectiveness of the device.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

The provided document describes non-clinical bench tests conducted to verify that the proposed device (PG-800A Series Electronic Blood Pressure Monitor) met all design specifications and was Substantially Equivalent (SE) to the predicate device (Electronic Blood Pressure Monitor PG-800A, K102920).

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

   • The document states that "Bench tests were conducted." It does not specify the sample size for human subjects or the number of measurements taken during these bench tests that would be considered a "test set" in the context of clinical performance. It also does not specify the origin of any data, if human data was used, nor if it was retrospective or prospective. The tests mentioned are primarily for compliance with standards.

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):

   • This information is not provided in the document. The document refers to "bench tests" and compliance with standards like AAMI SP10, which typically involves comparison to a reference standard, not a panel of experts establishing ground truth.

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

   • This information is not provided as the study described is non-clinical bench testing for compliance. Clinical adjudication methods are not relevant here.

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. The device is an automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

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

   • The presented data is the standalone performance of the device's measurement accuracy against the claimed specifications and relevant standards. The "bench tests" confirm the device's ability to measure blood pressure and pulse rate accurately according to the stated ranges and accuracy.

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

   • For the "BP Accuracy" and "PR Range" acceptance criteria, the implicit "ground truth" for the bench tests would be a highly accurate reference measurement device or method, as specified by the AAMI SP10 standard (e.g., using a mercury sphygmomanometer or highly calibrated electronic reference). The document states compliance with AAMI SP10:2002/(R) 2008 & A1:2003, which sets out requirements for accuracy testing against a reference standard.

7. The sample size for the training set:

   • This information is not applicable as the device described is an electronic blood pressure monitor, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Its operation is based on an oscillometric principle.

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

   • This information is not applicable for the reasons stated above.

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PG-800B 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. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

The proposed device, PG-800B Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at arm within its claimed range and accuracy via the oscillometric technique. The device has the data storage function. It has an 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.

Here's a breakdown of the acceptance criteria and the study details for the PANGAO® PG-800B Electronic Blood Pressure Monitor, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary references performance and clinical verification testing per ANSI/AAMI SP10:2002+A1:2003+A2:2006. This standard outlines the accuracy requirements for automated sphygmomanometers. While the exact numerical acceptance criteria and reported performance are not explicitly detailed in the provided text, the fact that the device was cleared implies it met these standards.

Based on the ANSI/AAMI SP10 standard, the general acceptance criteria for blood pressure monitors typically require:

• Mean difference: The average difference between the device's readings and a reference standard (e.g., auscultatory measurements by trained observers) should be within a specific range (e.g., ±5 mmHg).
• Standard deviation (or overall accuracy within a range): The standard deviation of these differences should also be within a specified limit (e.g., 8 mmHg).
• These criteria usually apply independently to both systolic and diastolic blood pressure measurements.

Without the specific test report, I cannot provide the exact reported device performance values. Therefore, the table below reflects the implied acceptance criteria from the referenced standard, noting that the reported performance would have met these.

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

• Sample Size: The provided document does not explicitly state the sample size used for the clinical verification test.
• Data Provenance: The document states the sponsor is "Shenzhen Pango Electronic Co., Ltd" in Guangdong, China. The submission correspondent is "Shanghai Mid-Link Consulting Co., Ltd" also in China. This strongly suggests the data was collected in China. The study type is a clinical verification test, which typically implies prospective data collection for accuracy validation against a reference method.

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

• The document does not specify the number of experts or their qualifications.
• In the context of ANSI/AAMI SP10 testing, ground truth for blood pressure measurements is typically established by at least two, and often three, trained observers using a standardized auscultatory method, calibrated sphygmomanometers, and following strict protocols. These observers are usually medical professionals (e.g., nurses, physicians, or trained technicians).

4. Adjudication Method for the Test Set

• The document does not explicitly state the adjudication method.
• For ANSI/AAMI SP10 standards, if multiple observers are used, discrepancies are often handled by:
  • Averaging: Taking the average of the observers' readings if they are within a pre-defined acceptable range.
  • Third observer: If the initial two observers disagree beyond the acceptable range, a third independent observer's reading might be taken, or the average of the two closest readings might be used. The 2+1 or 3+1 methods are common.

5. 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 more common for diagnostic imaging AI devices, where the AI assists human readers. For a blood pressure monitor, the primary effectiveness is its standalone accuracy.

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

• Yes, a standalone study was done. The clinical verification test per ANSI/AAMI SP10 is designed to assess the accuracy of the device (algorithm and hardware combined) against a reference standard without human intervention influencing the device's measurement. The device itself is the "algorithm only" in this context of a blood pressure monitor.

7. The Type of Ground Truth Used

• The ground truth used would be "expert consensus" or "reference measurement." Specifically, it would involve auscultatory blood pressure measurements taken by trained human observers using a mercury or aneroid sphygmomanometer as the gold standard, against which the automated oscillometric readings from the PG-800B device are compared.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set sample size. For a physically-based device like a blood pressure monitor using an oscillometric technique, while calibration and internal algorithm development involve data, it's not typically a "machine learning" training set in the same way an image recognition AI would have. The "training" here would be part of the device's engineering and calibration processes.

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

• As above, the document does not provide details on a specific training set or its ground truth establishment. The development of oscillometric algorithms involves extensive engineering and physiological modeling. While large datasets of oscillometric waveforms and corresponding auscultatory readings might be used during the development and calibration phases, these are generally not described as "training sets" in regulatory documents for such devices in the same vein as AI/ML applications. The underlying physics and signal processing are the "ground truth" for the algorithm itself, validated against clinical standards like ANSI/AAMI SP10.

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PG-800A 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 proposed device, PG-800A Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function. It has an 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.

Here's a breakdown of the acceptance criteria and study information for the PG-800A Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document states that "Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was conducted. This standard outlines acceptance criteria for non-invasive automated sphygmomanometers. While the specific numerical acceptance criteria for mean difference and standard deviation are not explicitly listed in the provided text, the successful completion of the test per this standard implies that the device met its requirements. The "reported device performance" would be the results obtained from this clinical verification test; however, these specific numerical results (e.g., mean difference and standard deviation of blood pressure measurements) are not detailed in the provided document.

Therefore, I can present the information as follows, indicating where details are inferred or missing:

Study Details

Based on the provided text:

1. Sample size used for the test set and the data provenance: The document states that a "Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was performed. This standard typically mandates a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution) for clinical testing. However, the exact sample size used for the test set is not explicitly stated in the provided 510(k) summary. The data provenance (country of origin, retrospective/prospective) is also not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For blood pressure monitors, the "ground truth" is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer or another validated reference method. The ANSI/AAMI SP10 standard specifies requirements for these observers (e.g., being blinded, trained according to specific protocols). However, the number of experts and their specific qualifications are not explicitly stated in this document.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: For blood pressure measurement validation studies, ground truth is often established by multiple observers (e.g., two observers taking simultaneous measurements, with a third observer for adjudication if there's a discrepancy). While this is common practice for AAMI SP10 studies, the specific adjudication method used is not detailed in the provided text.

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 device is an electronic blood pressure monitor, not an AI-assisted diagnostic tool for imaging or complex data interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this type of device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described "Performance and Clinical Verification Test per ANSI/AAMI SP10" is a standalone performance test for the device (algorithm only), assessing its accuracy against a reference standard without human-in-the-loop interaction for interpretation, beyond the initial cuff placement and operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement accuracy studies conforming to ANSI/AAMI SP10 is established through simultaneous auscultatory measurements taken by trained expert observers using a validated reference mercury sphygmomanometer (or an equivalent validated oscillometric device).

7. The sample size for the training set: This device is a traditional electronic medical hardware device based on an oscillometric technique, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense of AI development. Therefore, the concept of a "training set" and its sample size is not applicable to this device.

8. How the ground truth for the training set was established: As the concept of a "training set" is not applicable, establishing ground truth for a training set is also not applicable. The device's measurement principle is based on established oscillometric algorithms, which are determined through physical and mathematical modeling, not empirical data training in the AI sense.

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