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The SEIOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Sejoy HCG One Step Pregnancy Test will be sold in three different formats:Strip,Cassette,and Midstream.The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device,a disposable plastic dropper,and a package insert.

The provided document is a 510(k) summary for the SEJOY hCG One Step Pregnancy Test, a medical device for qualitative detection of hCG in urine. It details the device's performance characteristics, including analytical performance and method comparison studies.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific positive/negative compliance rate targets for a combined "test set" in the way a rigorous AI/ML performance study might. Instead, it presents performance data from multiple analytical and comparative studies. However, for a qualitative test like this, the implicit acceptance criteria are generally 100% agreement for negative and sufficiently high agreement (often 95% or higher) for positive cases, especially at and above the claimed sensitivity. The performance tables demonstrate this.

Here’s a summary of the relevant performance data, interpreted as meeting implicit acceptance criteria:

Device Performance Summary (Based on provided data):

Detailed Performance Tables from the text (Acceptance Criteria met where "100%"):

Analytical Performance (Precision/Reproducibility/Sensitivity) - Combined Operator Data:

Strip Format: Operator 1&2&3

Cassette Format: Operator 1&2&3

Midstream Format: Operator 1&2&3

Method Comparison Study (N agreement with predicate device):

• Strip Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
• Cassette Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
• Midstream Format (dip): Positive: 63/63 (100%), Negative: 72/72 (100%)
• Midstream Format (simulate stream): Positive: 63/63 (100%), Negative: 72/72 (100%)

Lay Person Study (N agreement with professional results):

• Strip Format: Positive: 46/46 (100%), Negative: 64/64 (100%)
• Cassette Format: Positive: 44/44 (100%), Negative: 66/66 (100%)
• Midstream Format (dip): Positive: 42/42 (100%), Negative: 68/68 (100%)
• Midstream Format (simulate stream): Positive: 45/45 (100%), Negative: 65/65 (100%)

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

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • Sample Size: For each format (Strip, Cassette, Midstream), and for each hCG concentration (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 3 different lots were tested. For each lot and concentration, 3 operators performed tests, with 2 runs per day for 15 days. This means for each operator, lot, and concentration, 30 replicates were performed (2 runs/day * 15 days = 30).
  • Total replicates per hCG concentration per format: 3 lots * 30 replicates/lot/operator * 3 operators = 270 replicates.
  • Total replicates across all concentrations for one format: 8 concentrations * 270 replicates = 2160 replicates.
  • Data Provenance: Not explicitly stated, but given the company is based in China (Hangzhou), the testing was likely conducted in China. The study is prospective as it involves controlled spiking of urine samples and systematic testing.

• Method Comparison Study (Clinical Performance in real samples):

  • Sample Size:
    • Strip and Cassette formats: Urine samples from 150 women. Approximately half (around 75) were suspected to be pregnant.
    • Midstream format: Urine samples from 135 women. Approximately half (around 67 or 68) were suspected to be pregnant.
  • Data Provenance: Not explicitly stated for the source of these patient samples. Implied to be clinical samples from patients presenting for pregnancy testing. The study design (comparing device to a predicate at POC sites) suggests a prospective clinical study.

• Lay Person Study:

  • Sample Size: 440 women.
  • Data Provenance: Not explicitly stated, but it describes "women's individual pregnancy status was self-tested, varying educational and occupational backgrounds were chosen for the study." This implies a prospective study involving real users.

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

• Analytical Performance: The ground truth for spiked samples (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL) is intrinsically defined by the known hCG concentrations. The hCG standard is "Traceable to the 5th WHO," indicating a robust and internationally recognized standard. The device's reading sensitivity is 25 mIU/mL. Human "experts" are not needed to establish this ground truth, as it's a precisely formulated laboratory experiment.
• Method Comparison Study: The ground truth for the clinical samples was established by the predicate device (CLUNGENE HCG Pregnancy Rapid Test, K193132). The study aimed to show conformity with this established method. "Three different health professionals for each format at the 3 POC sites for a total of 12 POC operators" were involved in testing the samples with both the proposed and predicate devices. Their qualifications (e.g., specific medical titles, years of experience) are not detailed, but they are referred to as "health professionals."
• Lay Person Study: The ground truth for the lay person study was "professional testing." This professional testing served as the reference standard against which the lay person's self-test results were compared. The specific qualifications of these "professionals" are not detailed.

4. Adjudication Method for the Test Set:

• Analytical Performance: No adjudication method as the ground truth is based on precise spiked concentrations. Results are reported directly based on optical interpretation of the test strips.
• Method Comparison Study: Not explicitly stated. However, given that multiple "health professionals" at "3 POC sites" tested the samples, it is implied that the results were compared directly between the proposed device and the predicate device. If there were discrepancies, the document does not describe a formal adjudication process (e.g., by a third, blinded reader). The results simply state 100% conformity, suggesting no discrepancies or that any discrepancies were resolved in a non-specified manner.
• Lay Person Study: Not explicitly stated. The lay person's self-test results were compared to "professional testing." It's implied that discrepancies (if any) would highlight issues with lay user interpretation. The reported 100% conformity suggests no discrepancies between lay user and professional results.

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 device is a simple, qualitative immunoassay (lateral flow test), not an AI/ML-driven diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable to this device. The studies were designed to confirm the device's accuracy against known concentrations, a predicate device, and lay user interpretation.

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

This is not a software-based AI algorithm. The device is a physical test strip/cassette/midstream that provides a visual reading (presence or absence of control and test lines). Its "performance" is inherently tied to the chemical reaction and the visual interpretation, whether by an operator (analytical/method comparison studies) or a lay person (lay person study). There is no "algorithm only" component that would perform independently of human interaction or a physical sample.

7. The Type of Ground Truth Used:

• Analytical Performance: Known, precisely titrated hCG concentrations (traceable to WHO International Standard 5th edition). This is a strong, objective ground truth for analytical sensitivity.
• Method Comparison Study: Predicate device results (CLUNGENE HCG Pregnancy Rapid Test, K193132). This is a comparative "gold standard" for regulatory purposes, showing equivalence to an already approved device.
• Lay Person Study: Professional testing results. This acts as the "gold standard" for the interpretation study, ensuring that device performance under lay use conditions is objectively assessed against trained personnel.

8. The Sample Size for the Training Set:

This document describes a K-number premarket notification for a medical device (hCG pregnancy test) that is based on a chemical immunoassay, not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" as would be relevant for an AI/ML model. The studies described are for validation and performance testing of the physical device.

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

As there is no training set for this type of device (non-AI/ML), this question is not applicable. The ground truth for the test and validation studies (as described in point 7) was established through known concentrations, predicate device results, and professional testing.

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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

The Arm-Type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

For BP-46 and BP-1304, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification. which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, and pulse rate information. They will display an irregular heartbeat symbol "《♥》" if an irregular heartbeat was detected during the measurement process. BP-46 can display average results in three ways.

The device is designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009. medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

The provided text describes a 510(k) submission for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) study regarding acceptance criteria, performance metrics, ground truth establishment, or multi-reader studies.

Therefore, I cannot extract the specific information requested in your prompt as it pertains to a different type of medical device clearance and study methodology. The document is for a non-AI, hardware-based blood pressure monitor and focuses on compliance with general safety and performance standards for such devices, rather than AI model performance or clinical utility compared to human readers.

Specifically, the following points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document states "The test result all meet or exceed the requirement of the standards" for non-clinical tests and "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" for clinical tests, but it does not provide specific numerical acceptance criteria or reported performance values.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 as there is no AI component or human reader element.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a device for direct measurement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a blood pressure monitor, "ground truth" typically refers to reference measurements (e.g., from an oscillometric or auscultatory method) rather than expert consensus on images or pathology. The document mentions compliance with ISO 81060-2, which dictates clinical validation methods for non-invasive sphygmomanometers, implying a comparison to a referencestandard, but the specific details are not provided.
8. The sample size for the training set: Not applicable as there is no AI or machine learning model for training.
9. How the ground truth for the training set was established: Not applicable.

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The Digital Thermometers MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages.

Models MT-1027, MT-4127, MT-4132, MT-4132, MT-4335, MT-4335, MT-4326, MT-09, MT-30, MT-31, and MT-36 are non-predictive digital thermometers. Models MT-4726 and MT-4735 are predictive digital thermometers. Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory. Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.

The provided document describes the Sejoy Electronics & Instruments Co., Ltd. Digital Thermometer MT series (Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36) and its substantial equivalence to predicate devices (MT-4119 and MT-4320).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. The key performance acceptance criteria can be inferred from the "Accuracy" row in the comparison table and the clinical accuracy evaluation for predictive models.

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

• Test Set Sample Size: The document does not explicitly state the sample size (number of subjects or measurements) for the "clinical accuracy evaluation" mentioned for predictive models MT-4726 and MT-4735. It only states that the evaluation was conducted "according to clause 201.102 of ISO 80601-2-56:2009". This standard would typically define the required sample size and testing methodology.
• Data Provenance: Not specified in the document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document only references compliance with ISO 80601-2-56:2009 for the clinical accuracy evaluation. This standard would define the requirements for reference temperature measurements, which would implicitly involve qualified personnel, but their role as "experts to establish ground truth" in the context of an AI device is not directly applicable here as it's a device measuring a physical quantity.

4. Adjudication Method for the Test Set

• Not applicable as this is a medical device for measuring a physical parameter (temperature), not an AI device making a diagnostic or interpretive output that would typically require expert adjudication for ground truth. The "ground truth" for temperature measurement would be established by a primary reference thermometer meeting metrological standards as outlined in ISO 80601-2-56.

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 relevant for AI systems that assist human readers in interpreting medical images or data. The device in question is a standalone digital thermometer, not an AI-assisted diagnostic tool.

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

• Yes, a standalone performance evaluation was done. The entire submission describes the standalone performance of the digital thermometers. Specifically for the "predictive models MT-4726 and MT-4735," a "clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009." This evaluation assesses the device's accuracy in measuring temperature without human interpretation of its output beyond reading the displayed value. The predictive algorithm itself is a "standalone" component of the device's operation.

7. The Type of Ground Truth Used

• Reference standard/metrological ground truth: For temperature measurement, the ground truth would be established using reference thermometers or calibrated temperature baths as per the requirements of ISO 80601-2-56 and ASTM E1112. The specific details, like the type of reference standard and its traceability, are not provided but would be implied by adherence to these standards. For the predictive models, the proprietary algorithm aims to predict the "balanced temperature after 5 minutes," which would be the "ground truth" target for the prediction.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly mentioned. The document describes a traditional medical device (digital thermometer), even with a predictive algorithm for some models. The term "training set" is typically used for machine learning models. While the predictive algorithm must have been developed and validated, the document does not present it as a machine learning model that would require a distinct "training set" in the sense of AI. The development of the proprietary algorithm would involve calibration and empirical data, but it's not described as a "training set" for an AI model.

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

• Not applicable / Not explicitly mentioned. As mentioned above, the concept of a "training set" with established "ground truth" for an AI model is not directly applied in the document's description of a digital thermometer, even for models with a predictive algorithm. The accuracy of the predictive algorithm would be validated against empirically measured "balanced temperatures" in a clinical setting as outlined by the ISO standard.

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Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It's intended for use on people of all ages.

The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient. Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover. The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.

Here's a breakdown of the acceptance criteria and study information for the Infrared Ear Thermometer (models ET-101D and ET-101H) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the precision (laboratory accuracy) and clinical accuracy, which align with the ASTM E1965-98 standard.

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

The document states that "Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965." However, specific sample sizes for the clinical test set are not provided in this document. The geographic provenance of the data (country of origin) is also not explicitly stated, but given the manufacturer is Sejoy Electronics & Instruments Co., Ltd. from China, it is highly probable the study was conducted there. The document does not specify if the study was retrospective or prospective, but clinical evaluations for device approvals are typically prospective.

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 evaluation. For temperature measurement devices, the ground truth is typically assessed against a highly accurate reference thermometer (e.g., rectal thermometer in a controlled setting) rather than subjective expert opinion.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

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

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 MRMC comparative effectiveness study was mentioned or conducted. This device is a diagnostic tool (thermometer) and does not involve human readers interpreting images or data where AI assistance would be relevant in that context. The "readers" are the users of the thermometer, and the output is a direct temperature reading.

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

This is an inherently standalone device in terms of its core function: the device measures temperature and provides a reading. The clinical accuracy and precision tests are essentially standalone performance evaluations in a clinical setting. There is no "human-in-the-loop" performance in the sense of a human interpreting the device's output and making a further diagnosis/decision that needs to be assessed for improvement with AI. The user reads the temperature; the device algorithm calculates it.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For clinical accuracy, the ground truth for temperature measurement devices is typically established by simultaneous measurements using a highly accurate and calibrated reference thermometer (often a rectal thermometer in a controlled environment) to which the investigational device's readings are compared. The document mentions compliance with ISO 80601-2-56 and ASTM E1965, which both define rigorous methods for establishing clinical accuracy against reference standards. While not explicitly stated as "rectal thermometer readings," this is the industry standard for such evaluations.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For a device like an infrared ear thermometer, there typically isn't a "training set" in the machine learning sense. The device's algorithm for converting infrared radiation to temperature is based on established physical principles and calibrated during manufacturing, rather than learned from a large dataset. The "training" for such a device would be more analogous to calibration and validation against physical standards.

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

Since a "training set" in the machine learning context is not applicable here, the concept of establishing ground truth for it is also not relevant. The device's underlying physics and algorithms are validated through bench testing and calibration against known temperature standards in a laboratory setting, and then confirmed for clinical accuracy against reference thermometers in human subjects.

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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.

The wrist-type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by "oscillometric method" and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure in the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minutes. There is a maximum pressure safety setting at 300 mmHg, the device will not inflate the pressure of cuff higher than 300 mmHg.

For BP-2220, BSP-22, 120 memories are divided into two groups as the predicate device BP-2206, with 60 memories each group. For BP-2116, BSP-21, 120 memories are for one group. For BP-2116, BP-2220, BSP-21, BSP-22, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic and pulse rate information. BP-2220 , BSP-21 , BSP-22 can calculate the average of the last three measurements as the predicate device BP-2206. BP-2220, BSP-21, BSP-22 will display an irregular heartbeat symbol "(♥)" if an irregular heartbeat was detected during the measurement process. BP-2116 cancels Irregular Heartbeat Detection and "Last 3 results average". For BP-2220, BSP-22, there are 3 optional functions and there is 2 optional functions for BSP-21 as BP-2206, and there is no optional function for BP-2116.

The devices are all designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

The document describes a 510(k) submission for the Sejoy Electronics & Instruments Co., Ltd. Wrist - Type Fully Automatic Digital Blood Pressure Monitors (models BP-2116, BP-2220, BSP-21, BSP-22). The submission aims to demonstrate substantial equivalence to a predicate device (Blood Pressure Monitor, Model BP-2206, K121355).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that clinical tests were performed to comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in a table within this document, ISO 81060-2 outlines detailed requirements for blood pressure device accuracy. Generally, for blood pressure measurement devices, the acceptance criteria are related to:

• Mean Difference: The average difference between the device readings and reference measurements (typically auscultation with a sphygmomanometer performed by trained observers). The standard usually requires this to be within a few mmHg (e.g., ±5 mmHg).
• Standard Deviation (or Variance): The variability of these differences. The standard usually requires this to be below a certain threshold (e.g., 8 mmHg).
• Individual Differences: A certain percentage of individual differences must fall within predefined limits.

The document reports that the "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." This statement serves as the reported device performance, indicating that the device met the specified accuracy criteria defined by the ISO standard.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical validation study. ISO 81060-2, however, specifies minimum sample sizes for clinical validation (e.g., typically a minimum of 85 subjects with specific distributions across age, gender, and blood pressure ranges). The assertion of compliance implies these minimums were met.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Clinical validation studies according to ISO 81060-2 are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: The document does not explicitly state the number of experts used. However, for clinical validation studies of blood pressure devices generally performed according to ISO 81060-2, at least two trained observers (experts) are required to take independent auscultatory measurements simultaneously to establish the reference blood pressure.
• Qualifications of Experts: The document does not explicitly state the specific qualifications of the experts. In the context of ISO 81060-2, these experts would typically be trained clinicians (e.g., physicians, nurses, or technicians) competent in the auscultatory method of blood pressure measurement.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not explicitly describe the adjudication method. For blood pressure validation studies using two observers, if there are significant disagreements between their readings, a third observer might be involved, or a specific predefined method for resolving discrepancies is used (e.g., averaging, excluding outliers). ISO 81060-2 provides guidelines for such situations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document pertains to a blood pressure monitor, which is a measurement device, not an imaging interpretation tool. Therefore, an MRMC study with "human readers improve with AI vs without AI assistance" is not applicable in this context.

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

• Standalone Performance: Yes, the clinical validation described is essentially a standalone performance assessment of the device's accuracy against a known reference standard (auscultatory measurements). The device operates automatically without direct human intervention in the measurement process after initiation. The comparison is between the automated device's output and the expert human measurements, making it an assessment of the algorithm/device's performance on its own.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is expert auscultatory blood pressure measurements. These are considered the gold standard for clinical validation of automated blood pressure devices according to ISO 81060-2.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a training set size. Blood pressure monitors typically do not involve "training sets" in the same way as AI/ML algorithms that learn from data. The device's algorithm for determining blood pressure (oscillometric method) is typically pre-programmed and validated, rather than continuously "trained" on new data in the field.

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

• Training Set Ground Truth: As there's no mention of a traditional "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for calibrating or developing the oscillometric algorithm during its initial design would have been established through controlled experimental settings and comparisons to invasive arterial measurements or highly accurate auscultatory methods. However, this document pertains to the validation of a finished device against the ISO standard, not its internal development process.

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Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with arm circumference of 22- 42cm.

The Arm-Type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-35, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension. Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-35 will display an irregular heartbeat symbol " (♥) " if an irregular heartbeat was detected during the measurement process. It can display average results in three ways.

The provided text describes the Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The device's performance is assessed against the accuracy requirements of ISO 81060-2:2013-05-01, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

Study Details

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

   • Sample Size: Not explicitly stated in the provided text for the clinical test set.
   • Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, the clinical validation study would inherently be prospective in nature.

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

   • Not explicitly stated in the provided text. ISO 81060-2 typically requires measurements from trained observers using mercury sphygmomanometers or an equivalent calibrated standard device as the reference (ground truth).

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

   • Not explicitly stated in the provided text. ISO 81060-2 specifies a protocol for obtaining reference blood pressure measurements, often involving multiple observers.

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, a MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, a standalone performance study was done. The clinical tests were performed to validate the accuracy of the automated device itself, which operates without human intervention during the measurement process.

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

   • The ground truth for blood pressure monitor validation studies is typically established by trained observers using a calibrated reference method, such as a mercury sphygmomanometer or an equivalent standard. This is an implied requirement of ISO 81060-2.

7. The sample size for the training set:

   • This is not applicable as the device is a standalone blood pressure monitor based on oscillometric technology and does not involve machine learning algorithms that require a separate training set. The "training" in this context refers to the development and calibration of the device's internal algorithms, not a data-driven machine learning training set.

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

   • Not applicable for the reason stated above. The device's internal algorithms are based on established physiological principles and engineering design, not a machine learning training process with an external ground truth dataset.

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Measure blood pressure (systolic and diastolic) and pulse rate.
The Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic and diastolic blood pressure and pulse rate.

The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-1305, BP-1307,BP-1211, BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-1305,BP-1307,BP-1312, BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13will display an irregular heartbeat symbol " " if an irregular heartbeat was detected during the measurement process. BP-1305,BP-1318, BP-1319, BP-1326, BSP-11, BSP-12, BSP-13 can display average results in three ways: BP-1307 can display the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements.

The Sejoy Electronics & Instruments Co., Ltd. Arm-type Fully Automatic Digital Blood Pressure Monitor (multiple models listed) underwent a clinical study to demonstrate its accuracy and substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The device aimed to meet the accuracy requirements of ISO 81060-2:2013, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

Note: The detailed numerical results for each criterion were not explicitly provided in the document, but the statement "Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01" implies that all these criteria were successfully met.

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

The document does not explicitly state the sample size used for the clinical test set. However, a clinical validation study following ISO 81060-2:2013 typically requires a minimum of 85 participants for accuracy assessment. Given the nature of a 510(k) submission, it is highly probable that the study was prospective and conducted with participants whose blood pressure measurements were taken specifically for the validation of this device. The country of origin of the data is not specified.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. According to ISO 81060-2:2013, oscillometric blood pressure monitor validation requires measurements by trained observers (typically two or more) using a mercury sphygmomanometer or an equivalent reference device. These observers usually have specific training and certification in blood pressure measurement to ensure accuracy and inter-observer reliability.

4. Adjudication Method for the Test Set:

The document does not explicitly state the adjudication method. In clinical validation studies for blood pressure monitors following ISO 81060-2:2013, the ground truth is typically established by simultaneous or sequential measurements by two or more trained observers. Discrepancies between observers are often resolved by a third trained observer, or through averaging if within an acceptable range, or by re-measurement. This often aligns with a "2+1" or similar consensus-based method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. The purpose of this submission was to demonstrate substantial equivalence and meet specific accuracy standards for a medical device, not to compare human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance evaluation was done. The clinical validation study described, which complied with ISO 81060-2:2013, assesses the device's ability to accurately measure blood pressure independently, without human intervention in the measurement process itself. The device is an "Arm-type Fully Automatic Digital Blood Pressure Monitor," implying it operates without a human 'in the loop' for the actual pressure measurement and reading.

7. Type of Ground Truth Used:

The ground truth used was expert consensus (or highly accurate reference measurements). Specifically, for blood pressure monitor validation according to ISO 81060-2:2013, the reference standard for comparison is typically simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference blood pressure device.

8. Sample Size for the Training Set:

The document does not specify a separate training set or its sample size. For medical devices like blood pressure monitors, the "training" (i.e., algorithm development and internal testing) is typically conducted by the manufacturer using internal data or publicly available physiological datasets. The clinical validation study, as described, serves as the independent test set for regulatory submission.

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

As no specific training set and its ground truth establishment are detailed in the document, this information is not available from the provided text. However, for internal development, manufacturers would likely use similar methods as the test set: expert auscultatory measurements against which the device's algorithms are refined.

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Measure blood pressure (systolic and diastolic) and pulse rate.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The letter confirms that the device, Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35, is substantially equivalent to legally marketed predicate devices. This determination is based on a review of the manufacturer's 510(k) submission, which would have included performance data, but that data is not present in this regulatory correspondence.

To answer your request, I would need access to the actual 510(k) submission or a separate study report for the Sejoy BP-35 device. The current document only provides:

• Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35
• Intended Use: Measure blood pressure (systolic and diastolic) and pulse rate.
• Regulatory Class: Class II
• Product Code: DXN

Without the actual performance data and study details, I cannot fill out the requested table or address the specific points about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies.

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The Fully Automatic Blood Pressure Monitors BP series and BM 40 are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.

The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-103H, BP-1304, BP-1305, BP-1307, BM 40, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-103H, BP-1304, BP-1307, BM 40 will display an irregular heartbeat symbol "( if an irregular heartbeat was detected during the measurement process. BM 40, BP-1307 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-103H, BP-1304, BP-1305 can calculates the average of the last three measurements. In addition, BP-1307 has LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

The provided document describes the Sejoy Electronics & Instruments Co., Ltd. Fully Automatic Digital Blood Pressure Monitor (BP series and BM 40 models) and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against the requirements of the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standards for manual, electronic or automated sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between the device and a reference measurement) are not explicitly stated in the document, it does state that the device meets or exceeds these requirements.

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

The document states that "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 National Standard for Manual, Electronic or Automated Sphygmomanometers."

However, the specific sample size for the test set is not provided in this document.
The data provenance (country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide details on the number of experts used or their qualifications for establishing the ground truth. It simply states that performance tests were conducted according to the ANSI/AAMI SP10 standard, which typically involves comparison against a reference measurement performed by trained observers (oscillometric vs. auscultatory method).

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. In the context of blood pressure monitor accuracy testing per AAMI SP10, the "ground truth" is typically established by trained observers taking auscultatory measurements simultaneously or in strict sequence with the automated device. The standard itself specifies the statistical comparison methods.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging algorithms where human readers interpret medical images. Blood pressure monitors are standalone measurement devices, and their accuracy is typically evaluated by comparing their readings against a validated reference method (e.g., auscultation by trained professionals).

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

Yes, a standalone performance evaluation was done. The document refers to "Performance Test according to ANSI/AAMI SP10:2002/(R) 2008..." and "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10...". These tests assess the device's accuracy in measuring blood pressure and pulse rate without necessarily involving human interpretation of the device's output in the loop, beyond reading the displayed values. The device itself is designed to provide automated measurements.

7. The Type of Ground Truth Used

The ground truth used for performance testing (as implied by adherence to ANSI/AAMI SP10) would be reference blood pressure measurements obtained by trained observers using a validated method, typically auscultation with a mercury or aneroid sphygmomanometer. The standard specifies the requirements for this reference method.

8. The Sample Size for the Training Set

This information is not provided in the document. Blood pressure monitors like these do not typically have an "AI algorithm" in the sense of requiring a large, separate training set for a machine learning model. Their design is based on established oscillometric principles.

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

As noted above, the concept of a "training set" in the context of an AI algorithm is largely not applicable to this device. The device operates based on a physical measurement principle (oscillometry) and its internal algorithms process these physical signals. Any calibration data or internal parameters would be established through engineering design and validation, not through a separate "training set" with ground truth in the AI sense.

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The Wrist-type Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

Measure blood pressure (systolic and diastolic) and pulse rate.

The wrist-type fully automatic digital blood pressure monitors uses an inflatable cuff which is wrapped around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-202H, BP-2208, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-202H, BP-2206, BP-2208 will display an irregular heartbeat symbol " if an irregular heartbeat was detected during the measurement process. BP-2208 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-202H, BP-2206 can calculate the average of the last three measurements. In addition, BP-2208 have LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission references the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standard for performance and clinical accuracy requirements. However, the document does not explicitly list the specific numerical acceptance criteria from this standard nor does it present a detailed table of the device's reported performance against these criteria. It only states:

"The test result all meet or exceed the requirement of the standards." (Non-clinical tests)
"Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10..." (Clinical tests)

To provide a hypothetical example of what such a table would look like if the specific values were provided in the submission (based on general knowledge of NIBP standards like AAMI SP10):

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The document only mentions that "Clinical tests were performed."
• Data Provenance: Not explicitly stated. Given the manufacturer's location (Hangzhou, China), it is plausible the data was collected there, but this is not confirmed. The document does not specify if the study was retrospective or prospective.

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

• Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard typically requires a minimum of two trained observers to establish reference blood pressure measurements.
• Qualifications of Experts: Not explicitly stated. The standard generally requires observers to be trained and validated in auscultatory blood pressure measurement using a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. For clinical validation according to ANSI/AAMI SP10, referent blood pressure is typically determined by trained observers using an auscultatory method. If multiple observers are used, their readings are usually averaged or adjudicated if they differ significantly. The document does not detail this.

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

• MRMC Study: No, this type of study was not conducted or mentioned. The device described is an automated 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

• Standalone Performance: Yes, the clinical tests performed evaluate the standalone performance of the device itself (the "algorithm only," as it's an automated device). The accuracy requirements of ANSI/AAMI SP10 validate the device's ability to measure blood pressure independently.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the clinical accuracy studies (as per ANSI/AAMI SP10), the ground truth for blood pressure measurements is established by expert auscultatory measurements (typically using a mercury sphygmomanometer) conducted by trained observers.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires distinct training and testing datasets for algorithm development. The "training" of such a device is inherent in its design, calibration, and manufacturing process based on established oscillometric principles.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a separate training set or AI/ML algorithm development in the provided document. The device operates on established physiological principles and engineering.

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