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The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions.

Nova One Blood Glucose Test Strips are for use with the Nova One Blood Glucose Monitors for quantitatively measuring glucose in venous, arterial and fresh capillary whole blood from the finger and forearm.

The monitor is a hand-held testing device that works in conjunction with Nova One glucose test strips to measure glucose in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose, the monitor also stores patient test and quality control test data.

The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.

A "battery low" warning will alert the user to change the batteries. Battery charge state information is available on the "monitor status screen". The user can select the auto shutoff option to conserve power when the monitor is not in use. Test data and monitor setup information will be stored in a nonvolatile format to prevent data loss.

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result.

The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls.

The provided text describes the Nova One Blood Glucose Monitoring System, which is substantially equivalent to the previously cleared Nova Max One Blood Glucose Monitor System (K112638). The Nova One system has an expanded indication for use to include whole venous and arterial blood, in addition to capillary blood.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a discrete "acceptance criteria" table with numerical targets, but instead states the device's characteristics and its equivalence to a predicate device, implying that meeting the predicate device's performance is the acceptance criterion.

The text states: "The performance of the Nova One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that medical professionals can obtain blood glucose results from venous/arterial blood that are substantially equivalent to the current methods for blood glucose measurements obtained from capillary blood and in the central laboratory." And "Results of laboratory and clinical testing demonstrate that the Nova One Blood Glucose Monitor produces results that are substantially equivalent to results obtained on the predicate device."

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

The document mentions "laboratory and clinical testing" but does not specify the sample size for the test set. It also does not explicitly state the country of origin of the data. The studies were likely prospective clinical studies given they involved healthcare professionals and lay users in "clinical settings," and "venous/arterial blood" for performance against central laboratory methods, which is typically collected prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts used or their qualifications. It refers to "current methods for blood glucose measurements obtained... in the central laboratory," implying that the ground truth was established by standard laboratory procedures, which are overseen by qualified laboratory personnel and clinicians, but specific numbers or qualifications are not provided.

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

The document does not mention any adjudication method.

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 a medical device for measuring blood glucose, not an AI-assisted diagnostic imaging or classification tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not done in this context.

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

The device (Nova One Blood Glucose Monitor) is inherently a standalone diagnostic tool. Its performance is measured directly by comparing its glucose readings against a reference method. The "algorithm" here is the electrochemical sensor and embedded software in the device, which performs its measurement without ongoing human interpretation during the actual glucose reading process. So, yes, a standalone performance evaluation was done implicitly through the "laboratory and clinical testing."

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

The ground truth for the test set was established by "current methods for blood glucose measurements obtained... in the central laboratory." This typically refers to a highly accurate reference laboratory method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement.

8. The sample size for the training set:

The document does not specify a separate "training set" or its sample size. Given this is a medical device approval for a glucose meter, the "training" typically refers to the development and calibration of the device's internal algorithms during its engineering phase, rather than a distinct machine learning "training set" in the common AI sense. The substantial equivalence argument also relies on the previous K112638 clearance.

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

As mentioned above, the concept of a "training set" with ground truth in the AI sense is not explicitly present. The device's underlying technology is stated as being "the same fundamental scientific technology" as the predicate device (K112638). This implies that the design and calibration of the device were based on established glucose measurement principles and validated against reference laboratory methods during the development of the original Nova Max One system. The current submission focuses on demonstrating equivalence and expanded indications for use.

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