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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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The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). Thev are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Based on an electrochemical biosensor technology and the principle of capillary action, DS-A 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 is displayed in 6 seconds.

The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of blood glucose in fingertip capillary whole blood. When the blood is applied to the edge of reaction zone, the blood is drawn into the reaction chamber and will display a reading on the meter. Only a small amount of blood is needed. The test strip for the quantitative measurement of blood glucose in the range is from 20-600 mg/dL (1.1-33.3 mmol/L).

This document describes the DS-A Blood Glucose Monitoring System and its adherence to acceptance criteria, supported by various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems typically involve accuracy compared to a laboratory reference method. The document presents results based on "lay user" (home user) and "professional" (clinical setting) studies, comparing the device to the YSI 2300 STAT Plus 1M glucose analyzer.

Acceptance Criteria (Commonly accepted for Blood Glucose Monitors):

• For Glucose Concentration < 75 mg/dL (4.2 mmol/L):
  • ≥95% of results within ±15 mg/dL of the reference method.
• For Glucose Concentration ≥ 75 mg/dL (4.2 mmol/L):
  • ≥95% of results within ±15% of the reference method.

Reported Device Performance (from the provided studies):

A. For Home Users (Lay User Study):

B. For Professionals (Accuracy Study):

Precision (Repeatability) Study Results:

2. Sample Size and Data Provenance

• Test Set for Lay User Study: 150 patients.
• Test Set for Professional Accuracy Study: 178 patients.
• Test Set for Precision Study: 40 tests per glucose concentration level (40, 80, 120, 200, 300 mg/dL), using oxygenated Heparin-venous blood.
• Data Provenance: The document does not explicitly state the country of origin for the patient data for the lay user and professional accuracy studies, but the manufacturer is from Taiwan, ROC. The studies appear to be prospective clinical studies where human blood samples were tested.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, the reference method used for comparison is the YSI 2300 STAT Plus 1M glucose analyzer, which is a widely accepted laboratory reference instrument for measuring blood glucose. This implies that the 'ground truth' is established by a highly accurate laboratory method, overseen by laboratory professionals, rather than by human expert consensus (e.g., radiologists, pathologists).

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by a reference laboratory instrument (YSI 2300), not by human interpretation or consensus that would require an adjudication method.

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

Not performed. This study focuses on the standalone performance of a medical device (blood glucose monitor) compared to a reference standard, not on the comparative effectiveness of human readers with or without AI assistance. Therefore, there is no effect size reported for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The device, the DS-A Blood Glucose Monitoring System, was tested on its own to measure blood glucose levels, and its readings were directly compared to the YSI 2300 reference analyzer. The "Lay User" and "Accuracy" sections provide these standalone performance metrics.

7. Type of Ground Truth Used

The ground truth used was laboratory reference method data, specifically readings from the YSI 2300 STAT Plus 1M glucose analyzer. This instrument is an established device for highly accurate glucose measurement in a controlled laboratory setting.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of device (blood glucose monitor) likely does not involve machine learning algorithms that require a distinct training phase with labeled data in the same way an AI diagnostic tool would. The studies described are validation studies for the finished product.

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

As there is no explicit training set mentioned for an AI/ML algorithm, this question is not directly applicable. If developmental testing was done, the ground truth would have similarly been established against a highly accurate laboratory reference method (like the YSI 2300) during the design and development phases of the device.

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