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The Dario LC Blood Glucose Monitoring System consists of the Dario LC Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario LC Blood Glucose Monitoring System. The Dario LC 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 LC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Dario LC 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 LC 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 LC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.

The provided text describes the 510(k) premarket notification for the Dario LC Blood Glucose Monitoring System. The relevant sections for acceptance criteria and study details are found primarily in the "Summary of Non-Clinical Data" and "Summary of Clinical Data" within the 510(k) Summary.

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

Important Note: The provided text is a summary (510(k) Summary) and does not contain the full details of the studies. Therefore, specific numerical acceptance criteria (e.g., exact precision targets, linearity ranges, etc.) and comprehensive study methodologies (like detailed sample sizes for specific tests, expert qualifications, or adjudication methods) are not explicitly stated. The document focuses on confirming that testing was done and the device "meets all of its associated specifications" or "successfully passed."

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Summary of Non-Clinical Data," the acceptance criteria are implicitly linked to the "associated specifications" for each tested category. The performance is stated as meeting these specifications or successfully passing the tests.

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

• Sample Size for Test Set:

  • In Vitro Testing (Repeatability, Intermediate Precision, Linearity, Operating Conditions, Environmental Conditions, Hardware, Communication Accuracy): Not explicitly stated. The summary only says these were "assessed."
  • Clinical Data (User Evaluation and Method Comparison study): Not explicitly stated. The summary only mentions "A User Evaluation and Method Comparison study was completed."

• Data Provenance (e.g., country of origin of the data, retrospective or prospective):

  • The submitter, LabStyle Innovation, Ltd., is located in Caesarea, Israel. This suggests the studies may have been conducted in Israel or a location convenient for the manufacturer.
  • The "User Evaluation and Method Comparison study" implies a prospective study involving human subjects.
  • Other performance tests (In Vitro, Electrical Safety, EMI) are laboratory-based and inherently prospective for the device under evaluation.

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

Not applicable for this device type (blood glucose monitor). Ground truth for a blood glucose monitor is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) or a predicate device, not by expert consensus on image interpretation or similar qualitative assessments.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is quantitative measurement against a reference, not subject to human interpretation requiring adjudication.

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 diagnostic measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers. The "Dario App" is described as merely the "display component of the Dario LC Blood Glucose Monitoring System," providing an "external display for the user to review blood glucose testing results." It does not perform "any diagnostic or clinical analysis function."

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

The device itself is a standalone (algorithm only) measurement system. The performance assessments listed (In Vitro, Repeatability Precision, Linearity, Electrical Safety, EMI, Communication Accuracy) evaluate the device's inherent performance. The "User Evaluation" aspect would typically relate to usability and user performance in obtaining a measurement, but the core accuracy is independent of the user interface per se, as the app is only a display. The clinical study confirmed the device's performance as used but the underlying measurement is standalone.

7. The Type of Ground Truth Used

• For the In Vitro performance, Repeatability, Intermediate Precision, Linearity, Communication Accuracy, the presumed ground truth is a highly accurate laboratory reference method for glucose measurement (e.g., YSI 2300 STAT Plus Glucose & L-Lactate Analyzer, often considered a gold standard for glucose in blood). The summary states the device "meets all of its associated specifications," implying comparison to such a reference.
• For the User Evaluation and Method Comparison study, the ground truth would be established by comparing the Dario LC Blood Glucose Monitoring System's readings to those obtained from a laboratory reference method or the legally marketed predicate device (Dario Blood Glucose Monitoring System K150817) on the same blood samples. The goal was to prove "substantial equivalence."

8. The Sample Size for the Training Set

No information about a "training set" is provided. This terminology is typically associated with machine learning or AI models. Given that the Dario LC is a blood glucose monitoring system, it likely uses established electrochemical measurement principles rather than a trainable algorithm in the AI sense. Therefore, there wouldn't be a "training set" in the context of typical AI device development. The device's internal calibration and algorithms would be developed and validated internally by the manufacturer, not "trained" on a dataset in the way an AI model is.

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

Not applicable, as there's no indication of a "training set" in the context of an AI/ML model for this device.

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