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The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V blood glucose meter and Bioland Blood Glucose Test Strips.

The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.

The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 blood glucose meter and Bioland Blood Glucose Test Strips.

The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.

The Bioland G-425-2V Blood Glucose Monitoring System consists of three main components: the meter (with voice feature , no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Glucose Control Solution (Control solution are the same as K191657) can be used with the Bioand G-425-2V Blood Glucose Monitoring System.

The Bioland G-425-2 Blood Glucose Monitoring System consists of three main components: the meter (No voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Control Solution (Control solution are the same as K191657) can be used with the Bioland G-425-2 Blood Glucose Monitoring System.

The Bioland G-425-2V / G-425-2 Blood Glucose Monitoring System consists of:

• a) Bioland G-425-2V / G-425-2 Blood Glucose Meter;
• Bioland Blood Glucose Test Strips; b)
• C) Bioland Glucose Control Solution;

The provided text describes a 510(k) premarket notification for a Blood Glucose Monitoring System, which is a medical device, not an AI/ML algorithm. Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and study details (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel and are similar in intended use, technology, and performance to devices already on the market.

However, I can extract the acceptance criteria related to the device's performance as a blood glucose monitoring system, based on the inherent requirements for such devices, and the general claims of equivalence.

Extracted Information (based on typical blood glucose monitor requirements and general claims):

• Device Name: Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-45-2 Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Not for diagnosis or screening, and not for use in neonates.
• Measurement Range: 40~600 mg/dL
• Specimen Type: Capillary whole blood from fingertip
• Enzyme: Glucose oxidase (indicating an electrochemical detection method)
• Test Principle: Amperometric glucose biosensor
• Measurement Unit: mg/dL
• Hematocrit Range: 20%~60%
• Sample Volume: ≥0.7uL
• Test strip calibration: No code function, no need to calibrate the meter
• Operating Range: 50104°F (1040°C), 15~85%RH
• Measuring Time: 6s

Regarding "Acceptance Criteria" for this type of device:

For blood glucose monitors, acceptance criteria are typically defined by accuracy standards (e.g., ISO 15197:2013). While the exact numerical criteria from such standards are not explicitly stated in this document, the submission claims that "All test results met acceptance criteria" in reference to verification and validation activities. The core of the substantial equivalence claim relies on the subject device performing equivalently to the predicate device, which itself would have met relevant performance standards.

Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly list the specific numerical acceptance criteria (e.g., X% of results must be within +/- Y mg/dL of a reference method) nor detailed efficacy performance data, I can only populate the table with the claimed functional equivalence to the predicate device and the general performance specifications provided.

Regarding the AI/ML specific questions (for which the document provides NO information):

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. This is a hardware device with an algorithm, not an AI/ML model being assessed in an independent test set in the way the prompt implies. The testing would be clinical (human subject studies) and analytical (bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for a blood glucose monitor is typically established by comparing its readings to a highly accurate laboratory reference method (e.g., YSI analyzer), not by human expert consensus or radiologists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. See point 3.
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/Not provided. This is not an AI-assisted diagnostic tool for human readers. It's a direct measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is the standalone measurement system for the user.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for blood glucose monitoring systems is established by comparison to a laboratory reference method (e.g., YSI Glucose Analyzer) which provides highly accurate and precise glucose concentration measurements. This is intrinsic to the analytical accuracy assessment of blood glucose meters.
8. The sample size for the training set: Not applicable/Not provided. Blood glucose meters use fixed algorithms based on electrochemistry, not AI/ML models that require training sets in the conventional sense. The "training" would be the initial development and calibration of the chemical and electrical components and the non-AI algorithm.
9. How the ground truth for the training set was established: Not applicable/Not provided. The ground truth in the development/calibration phase would also be established using highly accurate laboratory reference methods.

In summary: The provided document is a 510(k) summary for a conventional medical device (blood glucose monitor) demonstrating substantial equivalence. It does not pertain to an AI/ML algorithm requiring the specific types of studies and acceptance criteria outlined in the prompt for AI/ML performance. The "study that proves the device meets the acceptance criteria" in this context refers to standard analytical and clinical performance studies required for blood glucose meters, which are implicitly stated to have been successfully completed as part of the overall "verification and validation activities" that showed "All test results met acceptance criteria."

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The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.

The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features: 1) The device is intended to be used in the homecare environment; 2) The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries; 3) Switching between °C and °F; 4) Multi-functional, can measure ear and forehead temperature; 5) The 32 sets measurement data can be stored, the user can view the previous measurement results; 6) Low battery indication, and auto shut-down within 30s.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Infrared Thermometer (model: E201):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Measuring accuracy" in the comparison table and the clinical accuracy testing based on ISO 80601-2-56.

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

• Test Set Sample Size: 150 subjects total.
  • 50 subjects in the 0-1 year age group.
  • 50 subjects in the 1-5 years age group.
  • 50 subjects in the over 5 years age group.
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical accuracy study for the E201 infrared thermometer was performed," implying a prospective clinical study. It does not mention retrospective data.

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

This information is not provided in the document. The text only states that the "reference body site of infrared thermometer is oxter (axillary)" and that clinical accuracy/repeatability testing was performed. It doesn't specify how many experts established the ground truth or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable as the device is an Infrared Thermometer, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

This is not applicable in the context of an infrared thermometer. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated directly against a reference body site.

7. The Type of Ground Truth Used

• Ground Truth: The "oxter (axillary)" temperature as the reference body site.

8. The Sample Size for the Training Set

This information is not applicable as this is a traditional medical device (infrared thermometer), not an AI/ML device that requires a distinct training set. The device's algorithms are based on established physical principles of infrared radiation and temperature conversion, calibrated during manufacturing, rather than being "trained" on a dataset in the AI sense.

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

This is not applicable for the same reasons as point 8. The device's calibration and accuracy are verified against known temperature standards and clinical measurements (using oxter temperature as reference), not established through a "training set" with ground truth in the AI sense.

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The digital thermometer intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.

The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages. The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed. This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.

The provided text is a 510(k) summary for a digital thermometer (Models T103, T104). It describes the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's an analysis to extract the requested information, specifically focusing on the acceptance criteria and the study that proves the device meets them:

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

The document references compliance with several international and industry standards, including specific performance requirements related to temperature measurement accuracy. The acceptance criteria are implicit in these standards, and the reported performance is that the device "Pass[es]" the tests and "complies with the applicable requirements."

• Displayed temperature range
• Laboratory accuracy
• Ambient conditions for operation and storage
• Identification, marking, and documents
• Clinical accuracy and repeatability for axillary and oral measurements | Pass
  "The T103 and T104 digital thermometer complies applicable requirements of ISO 80601-2-56 and ASTM E1112 including displayed temperature range, laboratory accuracy, ambient conditions for operation and storage, identification, marking and documents."
  "The subject complies with the applicable requirements set forth in the referenced performance standards."
  "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." |
  | IEC 60601-1: 2005/A1: 2012 - Electrical Safety Testing
• General requirements, protection against electrical hazards, mechanical hazards, excessive temperatures, hazardous situations, fault conditions, and constructions. | Pass
  "The subject complies with the applicable requirements set forth in the referenced electric safety standard."
  "The digital thermometer complies with to applicable IEC 60601-1 requirements..." |
  | IEC 60601-1-2: 2014 - EMC Testing
• Radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, power frequency magnetic field immunity test. | Pass
  "The subject complies with the applicable requirements set forth in the referenced EMC standard."
  "The digital thermometer complicable IEC 60601-1-2 requirements..." |
  | IEC 60601-1-11: 2015 - Electrical Safety for Medical Devices in Home Healthcare Environment | Pass
  "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-11:2015."
  "For lay person, the IEC 60601-1-11 was performed and the thermometer is accordance with applicable requirements." |
  | IEC 60601-1-6 Edition 3.1 2013-10 - Usability | Pass
  "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-6:2010+A1:2013."
  "Usability testing was completed in accordance with IEC 60601-1-6 and the digital thermometer is complied with the applicable requirements of standard." |
  | ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 - Biocompatibility Testing
• Cytotoxicity, Sensitization, and Irritation for patient-contacting materials (cap and outer shell). | Pass
  "The subject complies with the applicable requirements set forth in the referenced biological evaluation standards."
  "Biocompatibility of patient-contacting materials (cap and outer shell) was performed according to ISO 10993-1/5/10..." |
  | Software Verification and Validation (according to "Guidance for the content for premarket submissions for software contained in medical devices") | "Software verification and validation report in accordance with 'Guidance for the content for premarket submissions for software contained in medical devices'." (Implicitly "Pass" as part of the overall acceptance for substantial equivalence.) |

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

• Test Set Sample Size: For clinical accuracy and repeatability testing, the study involved 150 subjects, divided into three age groups of 50 subjects each: infants (0-1 year), children (1-5 years), and adults (>5 years).
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, given the manufacturer is based in China and the nature of a 510(k) submission, it is likely that the testing (including clinical) was conducted in a controlled, prospective manner to meet regulatory requirements, potentially in China or a region where the standards are applicable.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical accuracy and repeatability testing. It simply states that "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." For a digital thermometer, the ground truth for temperature measurement is typically established by highly accurate reference thermometers or alternative validated methods under controlled clinical conditions, rather than expert consensus in the way image-based diagnoses might be.

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

The document does not mention any adjudication method for the test set. Given the nature of a digital thermometer measuring a physiological parameter (body temperature), adjudication by multiple readers is not typically applicable in the same way it would be for interpreting medical images. The "ground truth" for temperature measurement would be derived from a highly accurate reference method.

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, an MRMC comparative effectiveness study was not done. This study is for a digital thermometer, which is a direct measurement device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.

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

Yes, the primary performance evaluation for this digital thermometer is its standalone performance in measuring body temperature. This means its accuracy and repeatability are assessed directly against established standards (ISO 80601-2-56 and ASTM E1112) without human interpretation affecting the device's reading. The user simply reads the displayed temperature.

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

The ground truth for the clinical accuracy and repeatability testing for the digital thermometer would be highly accurate reference temperature measurements obtained through methods specified by the referenced standards (ISO 80601-2-56 and ASTM E1112). These standards outline precise methods for temperature measurement validation, often using known stable temperature baths or highly calibrated reference thermometers. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging AI would be.

8. The sample size for the training set

This document does not specify a training set sample size. Digital thermometers are hardware devices that perform a direct physical measurement using a thermistor and convert it to a digital display. They are not typically "trained" in the same way a machine learning algorithm would be. Their performance is inherent in their design, calibration, and manufacturing consistently across units.

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

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's performance is driven by its engineering and adherence to established physical principles and manufacturing tolerances, validated against standards using the test set described.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD.

Here's an analysis of the provided text regarding the acceptance criteria and study for the blood pressure monitor, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is gauged against established international standards. The most relevant standard for clinical accuracy is ISO 81060-2:2018.

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

• Sample Size for Test Set: 86 subjects.
• Data Provenance: The clinical data for the subject device (2008, A221-2) came from a clinical report of its predicate device (model: 2005, K number: K201467). The document does not specify the country of origin of this clinical data, nor does it explicitly state if the study was retrospective or prospective. However, given that it's a clinical validation study for a medical device according to a standard, it is highly probable that it was a prospective study.

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. ISO 81060-2:2018, the referenced standard for clinical accuracy, typically outlines requirements for independent observers and reference measurement methods, often involving trained clinicians using auscultation for comparison.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical study. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers taking reference measurements (e.g., auscultation) to compare against the automated device, and often mechanisms for resolving discrepancies. However, specific details are not provided here.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for imaging diagnostics where multiple human readers interpret cases. The clinical study performed here focuses on the accuracy and repeatability of the device itself against established reference methods per ISO 81060-2.

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

Yes, a standalone study was done. The clinical accuracy and repeatability testing, based on ISO 81060-2, assesses the device's performance directly in measuring blood pressure and pulse rate without human-in-the-loop assistance for the measurement process itself. The document states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." This refers to the device operating autonomously to take measurements.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy study would have been established by a reference method as stipulated by ISO 81060-2. This typically involves simultaneous auscultatory measurements performed by trained observers (often two) using a mercury sphygmomanometer or another validated reference device, compared against the readings from the automated blood pressure monitor.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of information is usually relevant for AI/ML-based devices. For a non-invasive blood pressure monitor, the "algorithm" refers to the signal processing and oscillometric method used to derive blood pressure values, which is based on established physiological principles and engineering, rather than a trainable machine learning model in the conventional sense that would require a distinct training set. The device's "algorithm" (the software algorithm for measurement) is stated to be the same as the predicate, suggesting it's a fixed algorithm, not one that undergoes iterative training.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

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Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above by detecting infrared heat from the forehead.

The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.

The provided document describes the Bioland Technology Ltd. Infrared Thermometer (Model E127) and its clearance through the FDA 510(k) pathway, asserting its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from international and national standards, specifying performance limits for accuracy and repeatability.

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

• Sample Size: 150 subjects for clinical testing, divided into three age groups:
  • Infants (0-1 year): 50 subjects
  • Children (1-5 years): 50 subjects
  • Adults (>5 years): 50 subjects
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "clinical accuracy and repeatability testing had been clinically assessed."

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 the ground truth in the clinical accuracy and repeatability testing. Clinical trials for thermometers, especially for substantial equivalence, often compare the device's readings against established reference methods, which serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. For clinical thermometer studies, the reference method (e.g., rectal or oral thermometer readings) typically serves as the "ground truth" against which the new device's readings are compared.

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. The study described focuses on the device's accuracy and repeatability against a reference standard, not on human reader performance with or without AI assistance. The device in question is an Infrared Thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.

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

Yes, a standalone performance assessment was done. The clinical accuracy and repeatability testing evaluated the Infrared Thermometer's ability to measure temperature directly, without human interpretation of complex data or AI assistance in a diagnostic context. The device itself is the "algorithm" in this context, directly providing a temperature reading.

7. The Type of Ground Truth Used

The ground truth for the clinical accuracy and repeatability testing would have been established by a reference method for body temperature measurement, likely an invasive or highly accurate contact thermometer (e.g., rectal temperature for infants or oral temperature for adults). The document implies this by stating the device was "clinically assessed to meet the requirements of clinical accuracy per the referenced standards" (ISO 80601-2-56 and ASTM E1965-98). These standards typically outline the methodologies for establishing such ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data" as would be relevant for machine learning algorithms. This device is an infrared thermometer, relying on physical principles of infrared radiation detection rather than a machine learning model that requires training data in the same sense. Therefore, there's no stated training set size.

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

As there is no mention of a "training set" in the context of machine learning, there is no discussion of how ground truth for a training set was established. The device measures temperature based on established physics principles and its design, which is then validated through clinical testing as described above.

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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.

The provided 510(k) summary describes the acceptance criteria and the study that proves the Bioland Technology Ltd. Blood Pressure Monitor (models 2005, 2006, 2006-2, 2006-2B) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical performance acceptance criteria for the Blood Pressure Monitor are derived from the ISO 81060-2 standard ("Non-Invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type"). While the document states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards," it doesn't explicitly list the numerical acceptance criteria from ISO 81060-2 within the summary. However, based on common interpretations of ISO 81060-2 for blood pressure monitors, the key performance metrics involve accuracy and standard deviation for both systolic and diastolic blood pressure.

A general understanding of typical ISO 81060-2 requirements suggests the following for blood pressure:

• Mean difference: within ±5 mmHg
• Standard deviation: ≤ 8 mmHg

The document only states "The subject device complies with the applicable requirements set forth in the referenced performance standard" for performance and clinical testing, implying these ISO-defined criteria were met. For pulse rate, the non-clinical comparison table mentions "Pulse Rate: Within ±5%," which is a direct performance claim.

• Mean difference: ≤ ±5 mmHg
• Standard deviation: ≤ 8 mmHg | Assessed to meet the requirements of clinical accuracy per the referenced standards (ISO 81060-2). Explicit numerical values for mean difference and standard deviation are not provided in this summary, but compliance with the standard implies these criteria were met. |
  | Pulse Rate Accuracy | Within ±5% (as per non-clinical comparison table) | "Pulse Rate: Within ±5%" (This is listed under "Measuring accuracy" in the non-clinical comparison table, implying both predicate and subject meet this. The clinical study also assesses repeatability.) The clinical study summary states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards," which would include pulse rate. |
  | Repeatability | (Criteria defined by ISO 81060-2 for repeatability) | Clinical accuracy and repeatability testing assessed to meet the requirements of clinical accuracy per the referenced standards. |

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

• Sample Size: 86 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Clinical studies for device approval are almost universally prospective, but this is not explicitly confirmed here. The manufacturer is based in China.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. Clinical validation of automated sphygmomanometers per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (at least two) as the reference method. However, this detail is missing from the summary.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method. For ISO 81060-2, it would typically involve comparing measurements from two (or more) trained observers to ensure high inter-observer agreement, or using standardized automated devices as a reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This section is not applicable to this device. This is a standalone diagnostic device for blood pressure measurement, not an AI-powered image analysis or diagnostic aid requiring human reader comparison.

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

Yes, a standalone study was done. The clinical testing described as "Clinical accuracy and repeatability testing" against the ISO 81060-2 standard is a standalone assessment of the device's algorithmic performance. The device provides automatic measurements without requiring human interpretation of raw data.

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

The ground truth for blood pressure measurement in ISO 81060-2 studies is typically established by simultaneous measurements using a reference method, usually auscultatory measurements performed by trained human observers using a mercury or an appropriate non-invasive sphygmomanometer. The document states it meets ISO 81060-2, implying this method was used, but does not explicitly detail it.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This device is likely based on established oscillometric principles and does not typically involve machine learning requiring large training datasets in the same way an AI diagnostic algorithm would. The "clinical testing" described here is for validation, not training.

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

As no training set is mentioned or directly implied for this type of device, this information is not applicable.

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The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.

The Bioland Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland Blood Glucose Monitoring System is not for use in neonates.

The Bioland Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.

The Bioland Blood Glucose Monitoring System is a device intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. It is for self-testing by people with diabetes at home.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on the FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016, and relevant CLSI and ISO standards. The studies evaluate various performance aspects of the system.

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

The document details sample sizes for various tests:

• User Performance Study (Lay User Study): The test set included 351 individual glucose measurements.
• Precision Testing (Within-run and Within-day): Tables provided show data for 3 lots of test strips, with measurements across 5 glucose concentration intervals. Although exact number of samples for each interval isn't explicitly stated, these tables typically involve multiple replicates (e.g., 10-20 replicates per lot per glucose concentration level). For example, it lists means, SDs, and CVs implying multiple measurements were taken.
• Other tests (Altitude, Hematocrit, Linearity, Interference, etc.): The specific number of individual samples for these tests is generally not explicitly quantified in the provided summary. However, these are standard laboratory tests that involve a sufficient number of replicates and samples at various concentrations to ensure statistical validity, following guidelines such as CLSI EP7-A2, CLSI EP6-A, and FDA guidelines.
• Data Provenance: The document does not explicitly state the country of origin of the data for these studies or whether they were retrospective or prospective. Given that Bioland Technology Ltd. is located in Shenzhen, Guangdong, People's Republic of China, it is highly probable that the studies were conducted in China. The studies are described as "Pre-clinical data" and "Summary of performance testing," suggesting they were specifically conducted prospectively for this 510(k) submission to demonstrate device performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts or their specific qualifications for establishing ground truth. Instead, it relies on a reference method, the Glucose Analyzer YSI 2300, which is a widely accepted and highly accurate laboratory instrument for determining blood glucose concentration. This method inherently serves as the "ground truth" comparator for the device's measurements.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned in the context of human expert review of results, as the studies primarily rely on direct comparison to a laboratory reference standard (YSI 2300) and quantitative statistical analysis. For the user performance study, the acceptance criteria are numerical (e.g., % of results within a certain bias), not subjective expert judgment that would require adjudication.

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

An MRMC study was not conducted. This device is a self-monitoring blood glucose system, not an imaging AI system where human readers assist or benefit from AI. The user performance study evaluates the lay user's ability to operate the device correctly and obtain accurate results, which is a different type of assessment than an MRMC study.

6. Standalone Performance (Algorithm Only)

The device itself (Bioland Blood Glucose Monitoring System) is an "algorithm only" or "standalone" device in the sense that it provides a direct glucose measurement without human interpretation beyond reading the displayed number. The performance tests described (Precision, Linearity, Hematocrit, etc.) directly assess this standalone performance against a proven reference method (YSI 2300). The user performance study then adds the human-in-the-loop component, evaluating the system's performance when operated by lay users.

7. Type of Ground Truth Used

The primary ground truth used for the performance studies (e.g., Altitude, Hematocrit, Linearity, Precision) is comparison to a laboratory reference method, specifically the Glucose Analyzer YSI 2300. This is a highly accurate and precise instrument that measures glucose in blood samples. For the user performance study, the "ground truth" for the glucose values themselves would also be obtained from such a reference method, against which the lay user's device readings are compared.

8. Sample Size for the Training Set

This document describes a premarket notification (510(k)) for a medical device that measures blood glucose. It is not an AI/ML device that requires a "training set" in the sense of machine learning. The device's underlying "algorithm" is the electrochemical biosensor technology. Therefore, the concept of a "training set" for an algorithm, as seen in AI/ML, does not apply here. The data presented are from verification and validation studies for a traditional in vitro diagnostic device.

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

As stated in point 8, the concept of a training set is not applicable to this type of device. The ground truth for the test and validation of the device's performance was established using a Glucose Analyzer YSI 2300 as the reference method.

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Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer ntended to be used for the indirect (non-invasive) measurement of diastohc, systolic blood pressure and pulse rate for adults only.

Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometers with Electronic Manometer intended to be used for the indirect (non-mvasive) measurement of diastohe, systolic blood pressure and pulse rate for adults only.

Bioland Blood Pressure Montor Model 2001 and Model 2004 respectively use an inflation cuff wrapped around the upper arm The cuff is inflated by a manual air pump

Bloland Blood Pressure Monitor Model 2003 and Model 2005 respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by an electrical air pump

Bioland Blood Pressure Montor Model 3000, Model 3002, respectively uses inflation cuffs wrapped around the wrists. The cuff is inflated automatically by an electrical arr pump

The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the mflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by arr pump The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement results including dastolic. systolic pressures and heart pulse rate are displayed on the LCD

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Bioland Blood Pressure Monitor models:

Acceptance Criteria and Device Performance for Bioland Blood Pressure Monitors

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Bioland Blood Pressure Monitors are primarily based on the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". The clinical performance is evaluated against the accuracy of a mercury-type sphygmomanometer.

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

• Sample Size: The clinical test involved 87 patients for each group of models (Model 2001/2003, Model 2004/2005, Model 3000/3001/3002). It is not explicitly stated if these are unique patients across all model groups or if the same 87 patients were tested with different models. Assuming 87 unique patients for each grouped model as presented.
• Data Provenance: The study was conducted in Feng Gang Overseas Chinese Hospital. The type of study (retrospective or prospective) is not explicitly stated, but clinical tests are typically prospective. The country of origin is implicitly China, given the hospital's name and location.

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

The ground truth was established by "normal mercury-type sphygmomanometers." This implies that the measurements were taken by healthcare professionals trained in using these devices. The document does not specify the number of experts, their qualifications (e.g., specific medical titles, years of experience), or if multiple experts were involved in taking reference measurements for the same patient.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1, or none) for establishing ground truth measurements from the mercury sphygmomanometers. It simply refers to "comparing to normal mercury-type sphygmomanometers," which suggests that the direct readings from these reference devices were used.

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. The study compares the device's measurements against a reference standard (mercury sphygmomanometer), not against human readers' performance with and without AI assistance. This device is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone performance study was done. The Bioland Blood Pressure Monitors are automatic devices that measure blood pressure using an oscillometric method. The clinical tests evaluate the accuracy of these devices' measurements (algorithm only) compared to the ground truth established by mercury sphygmomanometers, without human intervention in operating the device or interpreting its output.

7. The Type of Ground Truth Used

The ground truth used was "normal mercury-type sphygmomanometers." This is an accepted and common reference standard for non-invasive blood pressure measurement devices.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. This is a medical device clearance, and the focus is on the validation/test set performance against established clinical and engineering standards. For such devices, manufacturers typically use proprietary algorithms developed with internal data, and the submission primarily demonstrates performance on a separate, independent test set.

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

Since information about a specific training set is not provided, the method for establishing its ground truth is also not detailed in this summary.

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