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The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Test Strips. Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

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

Device Description

The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Dario is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

The Dario Blood Glucose Monitoring System consists of a device housing that includes a blood glucose meter and lancing device. The system also includes test strips, lancets, control solutions and a mobile application. The Dario meter does not require coding or separate batteries. The Dario meter is powered via the 3.5mm audio headphone jack of the smart mobile device. Users are instructed to insert the test strip into the meter, apply the blood or control solution to the test strip, after which the meter will process the test in approximately six (6) seconds and display the test result on the smart mobile device screen via the mobile application.

The Dario Blood Glucose Monitoring System uses Apple's iOS smart mobile device technology to view the glucose test results via a mobile application. This application is available for download via the smart mobile device's application store.

Test Principle:

The Dario Blood Glucose Monitoring System is an in vitro diagnostic device intended for the measurement of glucose in fresh whole capillary blood. The principle of the test relies upon a reaction between a specific type of sugar (glucose) in the blood sample and the glucose oxidase in the test strip. This reaction generates a small electrical current, which is measured by the meter. The meter calculates the blood glucose level based on an internal algorithm. The Dario application displays the test result via the smart mobile device display.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text for the Dario Blood Glucose Monitoring System, structured according to your request:

Acceptance Criteria and Device Performance

A key study for glucose monitoring systems is System Accuracy. The ISO 15197:2003 standard defines acceptance criteria for system accuracy. The device performance is reported against this standard.

Acceptance Criteria (ISO 15197:2003 for System Accuracy)	Reported Device Performance (Dario Blood Glucose Monitoring System)
For glucose concentrations < 75 mg/dL: At least 95% of the individual glucose results shall fall within ± 15 mg/dL of the reference method results.	System Accuracy Study: 100% of individual glucose results fell within 15 mg/dL of the YSI reference at glucose concentrations < 75 mg/dL. User Performance Study: 100% of individual glucose results fell within ± 15 mg/dL for glucose concentrations less than 75 mg/dL (11 out of 11 samples).
For glucose concentrations ≥ 75 mg/dL: At least 95% of the individual glucose results shall fall within ± 20% of the reference method results.	System Accuracy Study: 99.6% of individual glucose results fell within 20% of the results of YSI at glucose concentrations ≥ 75mg/dL. User Performance Study: 98.88% of individual glucose results fell within ± 20% for glucose concentrations greater than or equal to 75 mg/dL (88 out of 89 samples).
Precision/Repeatability: - CV ≤ 5% at blood glucose concentrations ≥ 100 mg/dL - Standard Deviation ≤ 5 mg/dL at blood glucose concentrations <100 mg/dL (typical industry expectation based on similar standards for repeatability, though not explicitly stated with these exact numbers in the provided text as 'acceptance criteria')	Precision/Repeatability Study: CV ≤ 4% at blood glucose concentrations ≥ 100 mg/dL and a standard deviation of ≤ 3 mg/dL at blood glucose concentrations <100 mg/dL. (This meets and exceeds typical precision expectations).
Linearity: A high correlation (R^2 value close to 1) between the device and reference method over the claimed measuring range.	Linearity Study: R^2 value of 0.998, demonstrating that the Dario Blood Glucose Meter is linear over the claimed blood glucose measuring range of 20-600 mg/dL.
Hematocrit Study: Acceptable bias relative to the reference method within the claimed hematocrit range.	Hematocrit Study: The % biases relative to the reference method were acceptable within the claimed hematocrit range of 20% to 60%.
Operating Conditions Study: Accurate results over the claimed temperature and humidity range.	Operating Conditions Study: Demonstrated that the Dario Blood Glucose Monitoring System produces accurate results over the claimed temperature range of 50-113°F (10-45°C) and claimed humidity range of 10-90%.
Altitude Study: Acceptable bias and performance at the claimed altitude.	Altitude Study: The results demonstrate acceptable bias and indicate acceptable performance at the claimed altitude of 10,000 feet.
Interference Study: No significant interference (within ± 10% difference in glucose measurement) from commonly found interfering substances at specified concentrations.	Interference Study: Defined 'no significant interference' as within ± 10% difference in glucose measurement. Limiting concentrations for various compounds (Ascorbic Acid, Uric Acid, Acetaminophen, Total bilirubin, Triglycerides, Cholesterol, Galactose, Ibuprofen, Lactose, Maltose, Methyl-DOPA, Xylose) were established and added to the labeling.

Study Details

Here's the breakdown of the study details as requested, based on the provided text:

Sample Size used for the test set and the data provenance:
- System Accuracy Study: 100 samples with glucose concentrations ranging from 24 to 479 mg/dL.
  - Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "venous whole blood samples" and "capillary whole blood samples" which implies human biological samples. The study is prospective in the sense that the device was tested against these samples as part of its performance validation.
- Precision/Repeatability Study:
  - Within-run: Venous whole blood samples spiked to five different glucose concentration ranges. 10 repeats for each level, 3 test strip lots, 10 meters, totaling 300 results per glucose level.
  - Between-day: Three levels of glucose control solutions. Each sample measured with 3 test strip lots and 10 meters, over 10 days, totaling 300 results per glucose level.
- Linearity Study: Six test strip lots and 17 glucose concentration samples. Each level measured in replicates of five using three test strip lots.
- Hematocrit Study: Venous whole blood samples with 11 different hematocrit levels, spiked to three glucose concentrations. Tested using 10 Dario meters and three lots of test strips.
- Operating Conditions Study: Five meters and three test strip lots. Five glucose levels of venous blood samples tested.
- Altitude Study: Capillary whole blood samples with glucose concentrations ranging between 49 to 424 mg/dL. Three different test strip lots and six Dario meters.
- User Performance Study:
  - Glucose concentrations < 75 mg/dL: 11 samples.
  - Glucose concentrations ≥ 75 mg/dL: 89 samples.
  - Data Provenance: Not explicitly stated, but implies human users testing blood samples (likely capillary whole blood from fingertips based on the device's indications for use).
- Interference Study: Venous blood spiked with two levels of glucose concentrations, further spiked with varying levels of potentially interfering substances.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth in all these studies was established using a "reference method," specifically mentioned as the YSI reference for the System Accuracy Study.
- For blood glucose meters, the reference method (like YSI) itself is a highly accurate laboratory instrument. The "experts" in this context are the trained laboratory personnel operating these reference instruments, not medical professionals providing clinical diagnoses.
Adjudication method for the test set:
- Not applicable as the ground truth is established by a highly accurate laboratory reference instrument (YSI) which provides a direct quantitative measurement. There is no subjective interpretation requiring adjudication among multiple human readers.
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, this is not an MRMC study. The Dario Blood Glucose Monitoring System is a standalone in-vitro diagnostic device that provides a direct numerical reading. It does not involve human "readers" interpreting images or data that an AI might assist with. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the device's core performance (e.g., System Accuracy, Precision, Linearity, Hematocrit, Operating Conditions, Altitude, Interference studies) was evaluated in a standalone manner against a reference method. The "algorithm only" aspect refers to the meter calculating the glucose level based on the electrochemical reaction; human interaction is limited to taking the sample and initiating the test. The "User Performance Study" does involve human users, but it's evaluating the system's accuracy when operated by lay users, not an "AI algorithm" in the conventional sense.
The type of ground truth used:
- Reference Method: Exclusively the "YSI reference" (or similar highly accurate laboratory method) for glucose measurement. This is considered a gold standard for in vitro glucose determination.
The sample size for the training set:
- The provided text describes performance validation studies. Information about the specific "training set" for the device's internal algorithm is not provided. Blood glucose meters typically use pre-calibrated sensor technology and algorithms developed through extensive R&D, but the details of that training data (if any in the "machine learning" sense) are not part of this 510(k) summary focused on post-development performance testing.
How the ground truth for the training set was established:
- As noted above, details regarding a "training set" for the algorithm are not provided. For this type of electrochemical device, the "ground truth" for calibration and algorithm development would be established through highly accurate laboratory reference methods (like YSI) for various glucose concentrations.

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K Number

K151658

Device Name

Gmate Origin Blood Glucose Monitoring System

Manufacturer

Philosys Inc.

Date Cleared

2015-12-01

(165 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K131230,K083468

Predicate For

N/A

Intended Use

The Gmate® Origin Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, thigh or calf. The Gmate® Origin Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Gmate® Origin 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 Gmate® Origin Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Gmate® Blood Glucose Test Strips are for use with the Gmate® Origin Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, thigh or calf.

Device Description

The Gmate® Origin Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® Origin System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management.

The Gmate® Origin Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The Gmate® Origin Blood Glucose Monitoring System do not require coding or calibration and uses 1 CR2032 (Lithium Ion Battery). Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds countdown to display the test result.

The test principle is:
This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs ar electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level.

AI/ML Overview

The document provided describes the Gmate® Origin Blood Glucose Monitoring System and 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 for blood glucose meters typically follow ISO 15197 standards. While the specific numerical thresholds for each criterion are not explicitly stated in this document, it refers to "pre-determined Pass/Fail Criteria" and meeting "all the reliability requirements and performance claims." The performance is compared against the YSI 2300 Glucose Analyzer as a reference.

Acceptance Criterion	Reported Device Performance (Summary)
System Accuracy	Demonstrated to meet reliability requirements and performance claims.
User Performance	Demonstrated to meet reliability requirements and performance claims.
Alternate-Site Blood Glucose Measurement	Demonstrated to meet reliability requirements and performance claims.
Precision	Passed test based on pre-determined Pass/Fail Criteria.
Linearity	Passed test based on pre-determined Pass/Fail Criteria.
Interference	Passed test based on pre-determined Pass/Fail Criteria.
Hematocrit	Passed test based on pre-determined Pass/Fail Criteria.
Altitude	Passed test based on pre-determined Pass/Fail Criteria.
Temperature/Humidity	Passed test based on pre-determined Pass/Fail Criteria.

Note: The document states that the device "met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria." However, the exact numerical acceptance limits and detailed results (e.g., percentage within ±15% or ±20% of reference) are not provided in this summary.

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

Sample Size for Test Set: 100 persons.
Data Provenance: The study involved 100 persons with diabetes and healthcare professionals "at a clinic center." The manufacturer's address includes "Republic of Korea" and "New York, NY, USA." Without further detail, it's not definitively clear if the clinical testing was conducted in Korea, the USA, or both. The study appears to be prospective as it involved measurements "obtained by patients with those obtained using the YSI 2300 Glucose Analyzer."

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

The document mentions that the test set data was collected from "100 persons with diabetes and healthcare professionals at a clinic center." The ground truth was established by comparing the device readings to results from a "YSI 2300 Glucose Analyzer, a laboratory instrument." The YSI 2300 is a highly accurate laboratory reference method for glucose measurement, and its calibration and operation would typically be performed by trained laboratory technicians or clinical staff, who could be considered experts in reference glucose measurement. However, the exact number and specific qualifications of the experts directly involved in establishing the "ground truth" (i.e., operating the YSI analyzer and interpreting its results for the study) are not specified.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Instead, it directly compares the Gmate® Origin readings to the laboratory reference standard (YSI 2300 Glucose Analyzer). Adjudication methods are more commonly used in studies involving subjective interpretations (e.g., medical imaging) to resolve discrepancies between readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or designed for this device. This type of study focuses on the diagnostic accuracy of human readers with and without AI assistance, which is generally not applicable to a blood glucose monitoring system that provides a direct numerical reading. The study focuses on the accuracy of the device itself compared to a reference standard.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "clinical performance evaluation testing included system accuracy, user performance, and alternative-site blood glucose measurement." These evaluations assessed the Gmate® Origin system's performance by comparing its readings directly with those obtained from the YSI 2300 Glucose Analyzer. This is a standalone evaluation of the algorithm/device as it functions independently to provide a glucose reading.

7. Type of Ground Truth Used

The type of ground truth used was a laboratory reference method – specifically, the YSI 2300 Glucose Analyzer. This is considered a highly accurate and reliable method for determining blood glucose concentration.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It primarily describes the performance evaluation studies. For devices like blood glucose meters with electrochemical principles, extensive "training data" in the AI/machine learning sense is not typically a primary component of their development and validation as it would be for pattern recognition or image analysis algorithms. Instead, their development relies on chemical and electrochemical engineering, and their validation on analytical performance studies. If there were any internal calibration or algorithm refinement using data, that information is not disclosed in this summary.

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

As noted above, information about a "training set" in the context of machine learning (and its associated ground truth) is not provided. The development and validation of this device likely relied on standard analytical chemistry and engineering principles, with performance validated through clinical and non-clinical studies against a laboratory reference.

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