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The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express 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 system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Connex 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 system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Connex Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

Both candidate devices are used with the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Glucose Control Solution, which are the same in chemical composition, fundamental scientific technology, intended use and operating principle as with the components of the predicate device, cleared in K170614. The only difference between the test strip & control solution of the candidate device and the ones of the predicate device is the brand name.

This is a medical device application for two blood glucose monitoring systems, GLUCOCARD Shine Connex and GLUCOCARD Shine Express. As such, the acceptance criteria are based on established performance standards for blood glucose meters, primarily ISO 15197:2013 or equivalent.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for accuracy or precision, nor does it provide specific numerical performance results for the new devices. However, it does refer to "pre-determined Pass/Fail criteria" and concludes that the device passed "all of the tests."

For blood glucose monitoring systems, a common standard for accuracy is ISO 15197:2013, which typically requires:

• **For glucose concentrations

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The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).

The On Callo Express Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.

The On Call® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.

The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.

The On Call Express Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the On Call Express Blood Glucose Monitoring System are based on the EN ISO 15197:2003 standard. The document states that the device "meets the accuracy requirements per EN ISO 15197:2003." Unfortunately, the specific numerical acceptance criteria from EN ISO 15197:2003 and the exact corresponding reported device performance values (e.g., % of results within ±15% or ±20% of reference for specific glucose ranges) are not detailed within the provided text. The text only provides a list of performance characteristics tested.

Therefore, the table below will list the relevant performance characteristics mentioned as being evaluated against the ISO standard in the "Laboratory Testing" section, and indicate that the exact reported performance values are not provided, but that the device meets the ISO standard.

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

• Test Set Sample Size: The document does not explicitly state the sample size (number of patients or measurements) for the clinical studies involving lay persons and trained laboratory technicians. It simply mentions "clinical studies were conducted with lay persons and trained laboratory technicians."
• Data Provenance: The document does not specify the country of origin for the data. The study involved "lay persons" and "trained technicians" using the device. It is a prospective study as it involved conducting clinical studies and laboratory testing for the device.

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

• Number of Experts: One "expert" device was used: the YSI Model 2300 STAT PLUS. The document does not specify a number of human experts involved in establishing the ground truth, but rather refers to readings obtained by "trained technicians."
• Qualifications of Experts: The ground truth was established by comparing the On Call Express Blood Glucose Monitoring System's readings to those from the YSI Model 2300 STAT PLUS (K913806), which is a laboratory reference method. The text mentions that "trained technicians" were involved in obtaining readings, implying they are qualified to operate such equipment and conduct these tests accurately. There is no mention of specific medical qualifications (e.g., radiologist with X years of experience) as this is a blood glucose monitoring device.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1 consensus). Instead, the method involved direct comparison of the test device's readings with a recognized laboratory reference method (YSI Model 2300 STAT PLUS). The goal was to establish accuracy by demonstrating concordance, not to resolve discrepancies between multiple human readers.

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 explicitly mentioned or described. This type of study typically involves assessing the performance of multiple human readers on multiple cases, often with and without AI assistance. The study described focuses on the accuracy of the device itself and its usability by lay persons compared to trained technicians using a reference method. It does not evaluate human reader improvement with AI assistance. The device itself is a standalone glucose monitor, not an AI assistant to human readers.

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

Yes, a standalone performance evaluation was conducted. The "Laboratory Testing" section lists numerous tests (repeatability, precision, accuracy, linearity, interfering agents, etc.) that evaluate the system's performance independently. The "clinical studies" also assess the device's ability to provide accurate blood glucose readings on its own, with lay persons simply operating it according to instructions. The comparison to the YSI Model 2300 STAT PLUS explicitly assesses the algorithm's (and integrated system's) accuracy against a gold standard.

7. The Type of Ground Truth Used

The ground truth used was reference laboratory measurement. Specifically, the On Call Express Blood Glucose Monitoring System's results were compared to those obtained from the YSI Model 2300 STAT PLUS (K913806), which is a widely accepted laboratory reference instrument for glucose measurement.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific training set or its sample size. This device is a blood glucose monitoring system, not a machine learning model that typically undergoes explicit "training" on a separate dataset in the way an AI diagnostic algorithm would. The development and calibration of such devices usually involve internal studies by the manufacturer, but the specific details of these are not disclosed as "training set" information in this 510(k) summary.

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

As no specific "training set" is mentioned in the context of a machine learning model, this question is not directly applicable. For the device's internal calibration and development, it's highly probable that similar reference laboratory methods (like YSI) would have been used, but the document does not elaborate on this.

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The Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.

The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

Here's an analysis of the provided text regarding the Express Blood Glucose Monitoring System, formatted to address your specific points:

Since this is a blood glucose monitoring system, the "acceptance criteria" are typically related to the accuracy and precision of glucose measurements, often compared against a reference method (like a YSI analyzer) or a predicate device. The "device performance" refers to the results obtained from the non-clinical and clinical testing sections.

Acceptance Criteria and Reported Device Performance

Additional Information Addressing Your Request:

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

   • Precision Study:
     • Within-run: Twenty replicates.
     • Between-run: Twenty replicates per day.
     • Blood Donors: Six different blood donors (for between-run).
   • Hematocrit Study: Not specified how many samples or donors were used for the hematocrit range evaluation, only the range of hematocrit (30-55%).
   • Altitude Study: Not specified, only mentions "two control solutions and capillary whole blood spiked to three different levels."
   • Dynamic Range/Linearity: Not specified how many samples/replicates were used, only that venous blood was spiked to cover the range.
   • Accuracy/Method Correlation: Not explicitly stated, but implies a diverse group of "both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighties, and a wide range of educational levels" was included.
   • Data Provenance: Not explicitly stated, but typically clinical studies for 510(k) submissions in the US are conducted in the US. The reference to "YSI plasma-referenced data" suggests a well-established laboratory method for comparison. The studies appear to be prospective as they describe specific testing protocols.

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

   • Not applicable as this is an in-vitro diagnostic device measuring a quantitative analyte (glucose). The "ground truth" is established by a highly accurate reference instrument (YSI 2300 analyzer) or by comparing against the predicate device. No human expert consensus for image interpretation is involved.

3. Adjudication method for the test set:

   • Not applicable. The "ground truth" (reference method) for glucose measurement doesn't involve subjective human adjudication. It's an objective measurement compared against another objective measurement.

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

   • Not applicable. This is not an imaging AI device requiring human reader interpretation or assistance. The study evaluates the device's accuracy in measuring glucose, which is a standalone quantitative measurement. The "patient use" aspect of the accuracy study implies that both clinicians and patients used the device, suggesting a form of usability/performance evaluation for different user groups, but not an MRMC study in the typical AI sense.

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

   • Yes, this entire study is effectively a standalone performance evaluation of the device (Express Strip Reader) itself. While patients and clinicians used the device, their role was as the users performing the test, not as "human-in-the-loop" for an algorithm's decision-making process. The system provides a direct blood glucose measurement.

6. The type of ground truth used:

   • Reference Method: YSI 2300 analyzer (for accuracy/method correlation, hematocrit, and dynamic range).
   • Predicate Device: Hypoguard Advance™ Blood Glucose Monitoring System (for substantial equivalence claims in precision and accuracy).
   • Spiked Samples: Used in precision, altitude, and dynamic range studies where known concentrations of glucose were introduced into blood samples or control solutions.

7. The sample size for the training set:

   • This is a traditional medical device (blood glucose meter), not an AI/machine learning product. Therefore, there is no "training set" in the context of machine learning model development. The device relies on a pre-programmed electrochemical or optical methodology, not a learned algorithm.

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

   • Not applicable for the same reason as point 7.

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