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iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System is intended to be used for:
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh

• . single person measurement only and should not be shared
  . 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
  iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
  Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
  The AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
  The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
  The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.

iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG5 and BG5L Wireless Smart Glucose meters are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.

Here's an analysis of the provided text regarding the iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iHealth BG5 and BG5L systems are based on the international standard ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. The document explicitly states that the system "conforms to... ISO 15197."

While the document mentions adherence to ISO 15197, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) from that standard, nor does it present a detailed table of reported device performance against those specific criteria. It states that "Non-clinical test and the clinical test are done according to the above standard."

Therefore, based only on the provided text, we can infer the acceptance criteria are those outlined in ISO 15197, but the numerical targets and direct performance comparison are not presented.

Summary of the Study Information from the Provided Text

1. Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Based on ISO 15197)	Reported Device Performance
   Not explicitly detailed in the document, but is implicitly the requirements of ISO 15197 for blood glucose monitoring systems.	"Non-clinical test and the clinical test are done according to the above standard (ISO 15197)." (Specific performance metrics against ISO 15197 are not numerically provided in this summary.)

   Note: The document states the device "conforms to... ISO 15197," implying that it meets the standard's performance requirements, but the specific numerical accuracy data is not presented in this 510(k) summary.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). While it mentions "clinical test," it doesn't elaborate on the study design or patient demographics.

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

   • Not specified in the provided text.

4. Adjudication Method for the Test Set:

   • Not specified in the provided text.

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

   • No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. This device is a blood glucose monitoring system, not an imaging device typically subject to MRMC studies. The primary evaluation is device accuracy against a reference method.

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

   • Yes, a standalone performance evaluation was done. The document describes "Non-clinical test and the clinical test" performed to demonstrate conformity to ISO 15197. This includes evaluating the accuracy of the device itself (the meter and test strips) in measuring glucose levels against a reference method. The device is intended for "self-testing" and "in vitro diagnostic use," implying its accuracy is evaluated independently of a healthcare professional's interpretation where the result itself is the "output."

7. Type of Ground Truth Used:

   • Not explicitly stated, but for blood glucose monitoring systems conforming to ISO 15197, the ground truth is typically a laboratory reference method (e.g., a YSI analyzer or similar). This is inferred from the standard's requirements for accuracy studies.

8. Sample Size for the Training Set:

   • Not applicable/Not specified. Blood glucose meters do not typically use "training sets" in the same way machine learning algorithms do. Their performance is established through analytical and clinical accuracy studies where the device's measurements are compared to a reference method on a set of clinical samples.

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

   • Not applicable/Not specified, as "training sets" are not typically used for this type of device. The accuracy of the device (meter and strips) would be assessed against a laboratory reference method during its development and validation.

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iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
· quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
· single person measurement only and should not be shared
• 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 iHealth BG3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter

iHealth BG3 Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG3 Smart Gluco-Monitoring System is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The appearance of iHealth BG3 meter is different from the predicate device. More over, the new device iHealth BG3 Smart Gluco-Monitoring System can not display the test results itself, it has to connect an iPhone or iPod touch to complete its function.

The iHealth BG3 Smart Gluco-Monitoring System's acceptance criteria are based on ISO 15197 for in vitro diagnostic test systems, specifically for blood-glucose monitoring systems used for self-testing in managing diabetes mellitus. The information provided does not contain specific numerical acceptance criteria (e.g., accuracy percentages or error grids) or detailed study results to demonstrate compliance with these criteria beyond a general statement that "Non-clinical test and the clinical test are done according to the above standard."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numbers.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that "Non-clinical test and the clinical test are done according to the [ISO 15197] standard."

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

• This information is not provided in the given text.

4. Adjudication method for the test set

• This information is not provided in the given text.

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 blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• The iHealth BG3 Smart Gluco-Monitoring System is an in-vitro diagnostic device that provides a direct numerical measurement of glucose. Its performance is inherently standalone in the sense that the device itself generates the glucose reading. It connects to an iPhone or iPod touch to display results, but the measurement itself is performed by the device and test strip. The performance evaluation would measure the accuracy of these readings against a reference method.

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

• For blood glucose monitoring systems complying with ISO 15197, the "ground truth" (or reference method) typically involves laboratory-grade glucose analyzers, often using methods like hexokinase or glucose oxidase reactions, which are considered highly accurate for quantitative glucose measurement. While not explicitly stated, it's highly probable that a laboratory reference method was used for comparison in the clinical and non-clinical tests.

8. The sample size for the training set

• This information is not provided in the given text. Blood glucose meters do not typically have "training sets" in the same way machine learning algorithms do. Instead, their development involves calibration and characterization using a range of known glucose concentrations.

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

• As mentioned above, the concept of a "training set" with ground truth in the context of machine learning isn't directly applicable here. The development and calibration of blood glucose meters involve rigorous testing against laboratory reference methods across the device's intended measurement range and various interfering substances to ensure accuracy.

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The AG-608N single 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 fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-608N single Blood Glucose Monitoring System 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 AG-608N single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.

The AG-608N MULTI 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 fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is only used with single-use lancing devices.

The AG-608N MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

AG-608N Single Blood Glucose Monitoring System and AG-608N MULTI Blood Glucose Monitoring System measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. Your meter measures the current, calculates the blood qlucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

Here's an analysis of the AG-608N Single and AG-608N Multi Blood Glucose Monitoring System, focusing on its acceptance criteria and the study that proves its performance, based on the provided FDA 510(k) files:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the AG-608N Single and AG-608N MULTI Blood Glucose Monitoring System conforms to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

While the specific numeric acceptance criteria for bias, precision, and accuracy as defined by ISO 15197 are not explicitly detailed in the provided text, the standard itself outlines these requirements. For instance, the 2003 version of ISO 15197 (which would likely be applicable around the 2011 submission date) typically requires:

• Accuracy: For glucose concentrations

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Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, AG-6081 Single Blood Glucose Monitoring System and AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System and AG-6951 Multi Blood Glucose Monitoring System. When used with the above Blood Glucose Monitoring Systems, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

Here's an analysis of the provided text regarding the Andon Health Care Management System Software's acceptance criteria and studies:

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

The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics beyond functional descriptions. The "Performance specifications, including any testing" section lists functionalities rather than measurable criteria with associated performance targets.

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

The document does not specify the sample size used for any test set or the data provenance. It only states, "Testing of Andon Health Care Management System Software included system test and unit test."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As the device is for data management and not diagnostic interpretation, it's unlikely a ground truth established by medical experts in the traditional sense would be applicable for the software's functional testing.

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

The document does not describe any adjudication 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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is a data management software, not an AI-powered diagnostic or assistive tool for human readers. Its purpose is to transfer, store, and display blood glucose data.

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

This refers to the software's inherent functional performance. The document states, "Testing of Andon Health Care Management System Software included system test and unit test," which implies standalone testing of the software's functions (e.g., data transfer, storage, display, printing). However, no specific details on the methodology or results of these tests are provided.

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

For software like this, "ground truth" would typically refer to the expected functional behavior and data integrity. The document does not explicitly state how this ground truth was established, but it would presumably be based on software requirements and specifications (e.g., if the meter stores X data points, the software should always accurately display X data points).

8. The sample size for the training set

This information is not provided. The software described does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. It's an application for data management.

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

Not applicable as the device is not described as an AI/machine learning model requiring a training set.

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Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

The AG-608 MULTI 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 fingertips. The AG-608 MULTI Blood Glucose Monitoring System is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-608 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-608 MULT1 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

The AG-608 Single 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 fingertips. The AG-608 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-608 Single Blood Glucose Monitoring System 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 AG-608 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

The AGS-1000 Single Blood Glucose Test Strips are for use with the AG-608 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System. When used with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

The provided text describes the 510(k) submission for the "Andon Health Care Management System Software" and its associated blood glucose monitoring systems. However, it does not contain detailed acceptance criteria and the results of a study designed to prove the device meets these criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy against a well-defined ground truth with sample sizes, expert qualifications, and adjudication methods for AI/software performance).

The submission focuses primarily on demonstrating substantial equivalence to a predicate device ("Clever Chek Health Care System Software") based on shared technological characteristics and intended use. The "Performance summary" section (8.0) simply states: "Testing of Andon Health Care Management System Software included system test and unit test," which is insufficient to extract the requested information.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication methods for a test set.
3. Effect size of human readers with/without AI assistance.
4. Standalone algorithm performance.
5. Type of ground truth used.
6. Sample size and ground truth establishment for a training set.

The document is a regulatory submission for a data management software accessory for blood glucose monitors, not an AI/ML device requiring rigorous clinical performance studies against a diagnostic ground truth. The "testing" mentioned is likely related to software functionality and safety, rather than diagnostic accuracy.

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The AG-6081 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.

The AG-6081 Single Blood Glucose Monitoring System 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 AG-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.

The AG-6951 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.

The AG-6951 Single Blood Glucose Monitoring System 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 AG-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AG-6081 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.

The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.

The AG-6951 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.

The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

AG-6081 and AG-6951 Single Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

While AG-6081 and AG-6951 MULTI Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, MULT! use test strips, Auto-disabling Lancing device and the control solutions.

The four blood Glucose Monitoring system AG-6081 Single, AG-6951 Single, AG-6081 MULTI and AG-6951 MULTI are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing with their predicate device. Only the appearance is different from their predicate device, and the new devices can test the blood glucose at the alternative site: the palm, the forearm, the upper arm, the calf and the thigh.

More over, AG-6951 Single and AG-6951 MULTI Blood Glucose Monitoring Systems have a voice function, which is also different from their predicate device.

This document describes the AG-6081 Single, AG-6081 MULTI, AG-6951 Single, and AG-6951 MULTI Blood Glucose Monitoring Systems (BGMS). These devices are intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The document focuses on comparing the new devices to a predicate device (AG-606 Blood Glucose Monitoring System, K073030) and claims conformity to relevant standards, but provides very limited details about the specific studies.

Here's an attempt to answer your questions based on the provided text, while acknowledging the severe limitations in the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the devices conform to the following standards:

• ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
• FDA Draft Guidance Document-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006
• CLSI/NCCLS Guideline, EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second edition

However, the specific "acceptance criteria" (e.g., accuracy percentages, bias limits) from these standards and the "reported device performance" in relation to these criteria are not explicitly provided in the text. The document only states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," implying that the devices met the performance requirements referenced in these standards without detailing the actual results.

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

This information is not provided in the document. There is no mention of the number of samples, participants, or the type of study (retrospective or prospective) used for performance evaluation. The country of origin of the data is also not specified, though the submitter is based in Tianjin, China.

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

This information is not provided in the document. The text does not detail any expert involvement in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader, multi-case comparative effectiveness study with human readers and AI assistance is not applicable to this type of medical device (blood glucose monitoring system). These devices are standalone measurement tools and do not involve human interpretation of complex images or data that AI would assist with in the usual sense of an MRMC study.

6. Standalone Performance Study

Based on the claim of conformity to ISO 15197 and FDA guidance for blood glucose monitoring systems, a standalone performance study would have been conducted. ISO 15197 specifies accuracy requirements for glucose meters, which are assessed by comparing meter readings to a reference method (e.g., laboratory analyzer). While the document states "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," the detailed results of such a standalone study are not explicitly presented.

7. Type of Ground Truth Used

For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., hexokinase method on a clinical chemistry analyzer) to measure blood glucose concentrations. The device's readings are then compared against these highly accurate reference values. This is implied by the nature of such devices and the standards cited, but not directly stated in the provided text.

8. Sample Size for the Training Set

This information is not applicable as blood glucose monitoring systems of this type (electrochemical biosensors) are not typically "trained" in the machine learning sense. Their performance is inherent to their design and manufacturing, rather than learned from a dataset.

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

This information is not applicable for the reasons stated above.

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The AG-695 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-695 Single Blood Glucose Monitoring System 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 AG-695 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a qlucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-695 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

The AG-695 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip.. The AG-695 MULT! Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-695 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a alucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-695 MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

The AG-696 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 Single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-696 Single Blood Glucose Monitoring System 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 AG-696 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 single Blood Glucose Test Strips are for use with the AG-696 Single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

The AG-696 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample from the fingertip. The AG-696 MULTI Blood Glucose Monitoring System is intended for testing outside the body ( in vitro diagnostic use) and is intended to be used by healthcare professionals for multiple patients in a professional healthcare setting as an aid in monitoring the effectiveness of diabetes control.

The AG-696 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AGS-1000 MULTI Blood Glucose Test Strips are for use with the AG-696 MULT! Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood sample.

This system should only be used with single-use, auto-disabling lancing devices.

The four blood Glucose Monitoring system AG-695 Single, AG-695 MULTI, AG-696 Single and AG-696 MILTI are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing but the appearance is different from their predicate device. More over, all of the four systems have a voice function.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG-695/AG-696 Blood Glucose Monitoring Systems:

The provided document is a 510(k) Summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of accuracy, sensitivity, and specificity in the way one might for a diagnostic imaging AI. For blood glucose monitoring systems (BGMS), the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a laboratory reference method, as defined by standards like ISO 15197.

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with ISO 15197 and FDA Draft Guidance Document "Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006." These standards set forth the acceptance criteria for accuracy. While the document mentions compliance, it does not explicitly present a table of acceptance criteria or detailed device performance statistics (e.g., mean absolute relative difference, percentage of results within specific error margins) in the provided text.

However, based on typical ISO 15197 (2003) guidelines (the likely version for a 2011 submission), common acceptance criteria for accuracy are:

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KD-5966 series Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-5966 series Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systelic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

For KD-5966, the operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the results can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 2×60 times. If any irregular heartbeat is detected, it can also be stapular the LCD. More over, it also has the function of averaging the last three measurements.

The provided 510(k) summary for the KD-5966 series Fully Automatic Electronic Blood Pressure Monitor does not contain sufficient information to comprehensively answer all aspects of your request regarding acceptance criteria and the study proving device performance in the format you've requested.

Specifically, it states that the device "conforms to the following standards," which implies that meeting these standards constitutes the acceptance criteria. However, it does not explicitly detail the performance metrics or numerical thresholds that comprise these criteria, nor does it provide a detailed study report that proves the device met those criteria.

Here's what can be extracted and what information is missing:

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

The document states that the device "conforms to the following standards" and that "appropriate test will be conducted and specified acceptance criteria will be met before KD-5966 is marketed." This implies the acceptance criteria are defined by these standards. However, the specific numerical performance targets (e.g., mean difference in mmHg, standard deviation) from these standards are not explicitly stated in this document. Thus, a table of "reported device performance" as direct numerical results is not available in the provided text.

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

This information is not provided in the document. The document only mentions that "appropriate test will be conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The determination of ground truth for a blood pressure monitor typically involves comparison against a reference method (e.g., auscultation by trained observers), not "experts" in the sense of image interpretation. However, the details of such a comparison are missing.

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

This information is not provided.

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 Fully Automatic Electronic Blood Pressure Monitor, which is a standalone measurement device, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study is not applicable and was not performed.

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

Yes, implicitly. As an "Automatic Electronic Blood Pressure Monitor," the device operates in a standalone mode to measure blood pressure. Its performance would have been evaluated directly against a reference standard to demonstrate its accuracy. However, the details of this standalone performance evaluation, beyond stating conformance to standards, are not provided in this summary.

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

The ground truth for a blood pressure monitor is typically established by comparative measurements using a standardized oscillometric or auscultatory reference method, often involving simultaneous readings by trained observers using a mercury sphygmomanometer or validated automated oscillometric device. The document does not explicitly state the type of ground truth method used, but it would be based on these established clinical measurement practices.

8. The sample size for the training set

This device is an automated blood pressure monitor based on oscillometric principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set for this device is not applicable. The device's underlying algorithm is based on physiological principles and validated engineering rather than data-driven learning.

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

As previously stated, the concept of a training set is not applicable for this type of device.

In summary: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized performance and safety standards for blood pressure monitors. It does not provide the detailed study reports or specific numerical performance data against acceptance criteria that would typically be found in a more comprehensive clinical or validation study report. The document relies on the implicitly defined performance criteria within the cited AAMI SP10 standard.

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AG-608, AG-610 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger only. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates. It is not intended for the diagnosis of or screening for diabetes mellitus.

AG-608, AG-610 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, lancets, lancing device and the control solutions (available if user requests). The AG-608, AG-610 blood Glucose Monitoring system is based on an electrochemical biosensor technology(electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available are used to test the performance of the device.

The provided 510(k) summary for the AG-608 and AG-610 Blood Glucose Monitoring Systems states that the devices conform to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. This standard specifies the acceptance criteria for blood glucose monitoring systems.

However, the summary does not explicitly list the specific acceptance criteria within ISO 15197, nor does it present a detailed table of the reported device performance against those criteria. It only generally states that "Non-clinical test and the clinical test are done according to the above standard."

Therefore, based solely on the provided text, a comprehensive table of acceptance criteria and reported device performance cannot be fully constructed. The other requested information is also largely absent from this specific summary.

Here's a breakdown of what can and cannot be extracted from the provided text, addressing each point of your request:

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

As mentioned above, the document states conformity to ISO 15197 but does not provide a specific table of acceptance criteria from that standard or the device's performance against them.

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

• Sample Size for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary.
• Retrospective or Prospective: Not specified in the provided summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified in the provided summary. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory instrument (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer), not typically by human experts.

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

Not applicable/specified. Adjudication methods are usually relevant for subjective interpretations (e.g., radiology reads), not for quantitative measurements like blood glucose, where a reference method is typically used to establish ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this is implicitly a standalone performance study. The device measures blood glucose levels without human interpretation of the measurement; the user reads the displayed numerical result. The performance data would be for the algorithm/device itself compared to a reference standard. However, the specific data is not provided.

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

Implicitly, the ground truth for blood glucose monitoring systems is established using a reference laboratory method (e.g., a highly accurate glucose analyzer) that is traceable to an internationally recognized standard. The document mentions "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]," and ISO 15197 requires comparison to a laboratory reference method.

8. The sample size for the training set

Not specified in the provided summary. For blood glucose meters, the "training set" doesn't refer to machine learning model training but rather to the data and calibration used during the device's development and manufacturing. This information is not typically detailed in 510(k) summaries.

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

Not specified in the provided summary. Similar to the test set, it would be established using a reference laboratory method for glucose measurement.

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