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Rightest Blood Glucose Monitoring System Wiz 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. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Wiz 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

Rightest Blood Glucose Monitoring System Wiz Plus 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. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Wiz Plus 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Rightest Blood Glucose Test Strip Wiz is used with Rightest Blood Glucose Meter Wiz Plus for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm.

Rightest Blood Glucose Monitoring System Wiz and Wiz Plus are identical with the exception of Bluetooth function for Rightest Blood Glucose Monitoring System Wiz Plus, which allows for wireless information transfer.

Rightest Blood Glucose Monitoring System Wiz and Wiz Plus consists of the following devices: Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, Lancing Device, and Sterile Lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

The provided text describes the 510(k) premarket notification for the Rightest Blood Glucose Monitoring System Wiz and Wiz Plus. It includes details about the device, its intended use, comparison to a predicate device, and summaries of non-clinical and clinical tests performed.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance (Implicit)

The document heavily relies on demonstrating "substantial equivalence" to a predicate device (Rightest GM280 Blood Glucose Monitoring System, K170143). While explicit numerical acceptance criteria for accuracy are not provided in the summary sections, the discussion of non-clinical and clinical tests implies that the device performance must be comparable to or within acceptable limits relative to the predicate device and established standards for glucose monitoring systems. Key performance aspects tested, which would imply related acceptance criteria, include:

Study Details

Based solely on the provided text, the information is limited, especially regarding detailed methodologies and numerical study outcomes beyond general statements of equivalence.

1. A table of acceptance criteria and the reported device performance: See the table above. Explicit numerical acceptance criteria are not provided in this summary. The performance is summarized as demonstrating "substantial equivalence" to the predicate.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for any of the non-clinical or clinical tests. For the User Performance Study, it mentions "capillary whole blood from fingertip, palm and forearm sample sites" but does not give a number of participants or samples.
   • Data Provenance: Not explicitly stated. Given the submitter's address (Taiwan), the studies were likely conducted in Taiwan, but this is not confirmed. It is a premarket notification, thus the data would be prospective for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text. The ground truth method for the "User Performance Study" is implied to be a comparison against the predicate device, but the details of the "true" glucose reference method (e.g., lab analyzer) are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned in the provided text.

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: Not applicable. This document is for a Blood Glucose Monitoring System, which is an in-vitro diagnostic device, not an imaging AI device that involves human reader interpretation. No human reader involvement or AI assistance is described for this type of device.

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

   • For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), these would inherently be standalone performance evaluations of the device's measurement capabilities.
   • The "User Performance Study" evaluates the accuracy when used by lay users, which is a human-in-the-loop performance, but the 'algorithm' (the device's internal measurement system) itself is performing the measurement.

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

   • For the non-clinical tests (precision, linearity, interference, sample volume, hematocrit), the ground truth would typically be established using a traceable, highly accurate laboratory reference method (e.g., a YSI analyzer for glucose). This is not explicitly stated but is standard for such evaluations.
   • For the User Performance Study, the ground truth is implied to be a reference method (likely a lab analyzer) against which both the new device and the predicate device's readings are compared for equivalence.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the traditional sense of machine learning. It's a glucose monitoring system whose performance is established through empirical testing rather than a learned model.

9. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device.

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