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The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of a multi use blood glucose meter, test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).

The Assure Prism multi BGMS are based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.

The provided text describes the Assure Prism multi Blood Glucose Monitoring System and states its substantial equivalence to a predicate device (ACURA Plus Multi BGMS, K131419). It includes information about disinfection studies but does not report on the clinical performance or acceptance criteria of the glucose monitoring system directly. Therefore, it's not possible to populate all the requested sections.

Here's the information that can be extracted or deduced from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state the acceptance criteria for the blood glucose monitoring system's accuracy, nor does it report its performance in terms of accuracy (e.g., against a reference method). It primarily focuses on the substantial equivalence to a predicate device and disinfection validation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions disinfection studies but not clinical performance studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as no clinical performance study with expert-established ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This is not applicable as the device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers.

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

This is not applicable as the device is a blood glucose monitoring system, not an algorithm-only device. Its performance is inherent to the system (meter and test strips).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For blood glucose monitoring systems, the "ground truth" for performance studies would typically be a laboratory reference method for glucose measurement (e.g., YSI analyzer). However, the document does not detail such a study or the ground truth used.

8. The sample size for the training set

This information is not provided.

9. How the ground truth for the training set was established

This information is not provided.

Summary of available information from the document:

The document largely focuses on demonstrating "substantial equivalence" of the Assure Prism multi Blood Glucose Monitoring System to a predicate device (ACURA Plus Multi Blood Glucose Monitoring System, K131419). The main points of the submission relate to:

• Device Name: Assure Prism multi Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertips and alternative sites (forearm, palm, thigh, and calf) for multiple-patient use in professional healthcare settings to monitor diabetes control. Not for neonates or diagnosis/screening of diabetes.
• Mechanism: Electrochemical biosensor technology (glucose oxidase).
• Comparison to Predicate: The candidate device and predicate device consist of the same meter and test strips, with same measurement principle, scientific technology, operating ranges, and performance characteristics. Changes are limited to meter button symbols, strip logo, and validation of additional disinfectants.
• Disinfection Study: Performed by an outside commercial testing service to evaluate the effectiveness of three disinfectants (Dispatch® Hospital Cleaner Disinfectant Towels with Bleach, CaviWipes1, PDI ®Super Sani-Cloth® Germicidal Disposable Wipe) in preventing the spread of blood-borne pathogens (using hepatitis B virus, HBV). Results demonstrated complete inactivation of live virus.
• Durability Study: Demonstrated that 10,950 cleaning and disinfection cycles (simulating 3 years of multiple-patient use) had no effect on the performance or external materials of the meter.

The document's purpose is to obtain 510(k) clearance based on substantial equivalence, and therefore doesn't detail new clinical performance studies with specific acceptance criteria as might be seen for novel devices or software with AI components.

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