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The i-QARE DS-W 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, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The i-QARE DS-W 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 i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Based on an electrochemical biosensor technology and the principle of capillary action, i-QARE DS-W Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 6 seconds.

This document describes the i-QARE DS-W Blood Glucose Monitoring System. However, it does not contain a detailed study report that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily providing a comprehensive study with detailed acceptance criteria and performance against those criteria.

Here's a breakdown of what can be extracted, and what cannot:

Information that can be extracted:

• Device Name: i-QARE DS-W Blood Glucose Monitoring System
• Predicate Device: DS-A Blood Glucose Monitoring System (K082965)
• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips, forearm, or palm for self-testing by people with diabetes at home. Not for diagnosis, screening, or neonatal use.
• Test Principle: Electrochemical biosensor with carbon electrodes.
• Measuring Time: 6 seconds
• Detecting Range: 20 ~ 600 mg/dL
• Sample Volume: 0.7 µL
• Specimen Type: Capillary whole blood from fingertip, palm, and forearm.
• HCT Range: 20 ~ 60 %
• Training Set Sample Size: Not explicitly stated, however, the document mentions "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System." This indicates that some clinical data was used.
• How ground truth for the training set was established: Not explicitly stated, beyond the general statement that "Pre-clinical and clinical data are employed". For glucose meters, ground truth is typically established using a reference laboratory method, but this is not detailed here.

Information that CANNOT be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: While there are limitations listed, and a general statement about "accurate results for the larger range have been validated. The results were all within ±15% acceptable range" concerning HCT, a formal table of explicit acceptance criteria and corresponding reported performance metrics (e.g., accuracy percentages, bias, precision) is not provided. The "±15% acceptable range" related to HCT seems to be the closest to an acceptance criterion mentioned, but it's not a comprehensive set.
2. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "relevant clinical and performance tests" but does not provide specific sample sizes for the test set or the country of origin/retrospective/prospective nature of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
4. Adjudication method for the test set: Not applicable and not mentioned, as this is typically for subjective assessments, whereas glucose measurement is objective.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable and not mentioned, as this device is a standalone measurement system, not an AI-assisted interpretation tool for human readers.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: The document describes a "Blood Glucose Monitoring System" which is inherently a standalone device. While the performance of the system as a whole is discussed, the specific term "standalone algorithm-only" in the context of human-in-the-loop is not explicitly used because it's not an AI-driven image interpretation system. Its performance is its standalone performance. No separate human-in-the-loop component is described beyond the user operating the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a blood glucose monitor, the ground truth would typically be a laboratory reference method (e.g., YSI analyzer).

Summary of available and unavailable information based on the input text:

In conclusion, the provided document is a regulatory submission for substantial equivalence. It highlights the device's features, intended use, and differences from a predicate device, but it lacks the detailed study results and specific acceptance criteria typically found in a dedicated performance study report.

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