(60 days)
The GLUCOCARD™ 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. 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 clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
GLUCOCARD™ 01-mini consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.
The provided text describes the ARKRAY GLUCOCARD™ 01-mini Blood Glucose Monitoring System and mentions a clinical study to evaluate system accuracy. However, it does not provide specific acceptance criteria or detailed results of that study, nor does it include information about sample sizes, ground truth establishment, or expert involvement in the way an AI/ML device study would.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will indicate where information is missing.
Here's a breakdown based on the provided text, with missing information noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (From "Functional and Safety Testing" section) |
|---|---|
| Specific accuracy metrics (e.g., % within ±X mg/dL of reference, ISO 15197 compliance, etc.) are not provided. | A clinical study was done with persons with diabetes to evaluate system accuracy. |
| Analytical verification testing was performed to evaluate precision, dynamic range, and linearity. |
2. Sample size used for the test set and data provenance
- Sample Size (Test Set): Not specified in the provided text. The text only mentions "A clinical study was done with persons with diabetes."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "persons with diabetes." Given the submitter's location (Minneapolis, MN, USA), it's highly likely the study was conducted in the USA, but this is an inference, not stated fact. The study was retrospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Not applicable/Not specified. For a blood glucose monitoring system, the "ground truth" is typically established by a laboratory reference method, not by expert consensus on images or interpretations.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified. This concept (e.g., 2+1, 3+1) is relevant for studies involving human readers and interpretations (like radiology), not for direct measurement devices where a reference standard provides the "truth."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a blood glucose monitoring system, not an AI/ML diagnostic tool meant to assist human readers in interpreting complex data.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "system accuracy" evaluated in the clinical study likely refers to the standalone performance of the device (meter + test strips) against a laboratory reference method. The text states: "A clinical study was done... to evaluate system accuracy." Analytical verification also covered precision, dynamic range, and linearity, which relate to standalone performance characteristics.
7. The type of ground truth used
- Type of Ground Truth: For blood glucose monitors, the ground truth is typically a laboratory reference method (e.g., a YSI Analyzer or equivalent) that is highly accurate and precise, performed on the same blood samples as the device under test. The document does not explicitly name the reference method but implies one was used to determine "system accuracy."
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not specified. This device is not described as involving machine learning or AI that would require a distinct "training set" in the conventional sense. The "Functional and Safety Testing" likely refers to validation cohorts.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. Since there's no mention of a training set for an AI/ML algorithm, this question is not relevant to the provided text.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.