(75 days)
The Ferrara 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.
The Ferrara Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Ferrara Blood Glucose Test Strips.
Here's an analysis of the acceptance criteria and the study conducted for the Ferrara Blood Glucose Monitoring System, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on a qualitative assessment of "good correlation" and "substantially equivalent" performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Good correlation between fingertip and alternate site results | Linear regression statistics, Clarke Error Grid Analysis, and Bias Analysis showed good correlation. |
| Substantial equivalence of palm alternate site to fingertip site | Testing demonstrated that the performance of Ferrara at the palm alternate site was substantially equivalent to that at fingertip. |
Study Information
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Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated as a numerical value, but the study included "both men and women, with both Type 1 and Type 2 diabetes, ages from 20 to 83 years." The tested blood glucose values encompassed the "45-328 mg/dL glucose range."
- Data Provenance: The document does not specify the country of origin. It was a clinical study comparing "fingertip results obtained by clinicians with alternate site results (palm) results obtained by participants with diabetes," implying a prospective clinical trial design.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document implies that "clinicians" obtained the fingertip results, which served as a reference point for comparison. However, the exact number of clinicians or their specific qualifications (e.g., years of experience, specialty) are not provided.
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Adjudication method for the test set:
- The document does not describe any specific adjudication method. The comparison was between clinician-obtained fingertip results and participant-obtained palm results.
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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:
- This was not an MRMC comparative effectiveness study involving AI. It was a diagnostic device validation study comparing two different sample collection sites for a blood glucose monitor.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This was a standalone device performance study, in the sense that the device itself (Ferrara Blood Glucose Monitoring System) was being evaluated for its accuracy at different sites. There is no mention of a separate "algorithm" being tested independently from the device.
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The type of ground truth used:
- The "ground truth" for the alternate site measurements (palm) was the "fingertip results obtained by clinicians." This represents a reference method comparison, where one measurement (fingertip) is considered the accepted standard against which the new method (palm) is evaluated.
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The sample size for the training set:
- The document does not mention a separate "training set" or "training data" as this is not an AI/machine learning device. The study described is a clinical validation study.
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How the ground truth for the training set was established:
- See above, not applicable for this type of device and study.
§ 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.