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The Nova Max Plus Blood Glucose and B-Ketone Monitoring System Monitor is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (βketone) in fresh capillary whole blood. It is intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Nova Max Blood Glucose and B-Ketone Monitor is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertip, forearm and palm or B-hydroxybutvrate (8-ketone) in fresh capillary whole blood obtained from the fingertip only.

Nova Max Glucose Test Strips are intended for use only with the Nova Max Blood Glucose Monitor and the Nova Max Plus Blood Glucose and B-Ketone Monitor. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

The Nova Max Plus Ketone Test Strips are intended for use only on the Nova Max Plus Blood Glucose and B-Ketone Monitor.

Nova Max Glucose Control Solutions are intended for use with the Nova Max Blood Glucose Monitor, the Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Normal, Low and High).

Nova Max Plus Ketone Control Solutions are intended for use with Nova Max Plus Blood Glucose and B-Ketone Monitor and Nova Max B-Ketone Test Strips as a quality control check to verify the accuracy of blood ketone test results. There are three levels of controls, (Levels 1,2 and 3).

The Nova Max Plus Blood Glucose and B- Ketone Monitoring System consists of:

1. Nova Max Plus Blood Glucose and B-Ketone Monitor
2. Nova Max Glucose Test Strips
3. Nova Max Glucose Control Solutions (Normal, Low and High)
4. Nova Max Plus B-Ketone Test Strips
5. Nova Max Plus B-Ketone Control Solutions (Levels 1,2 and 3)

The provided text is a 510(k) summary for the Nova Max Plus Blood Glucose and B-Ketone Monitoring System. Medical device 510(k) summaries, especially for in vitro diagnostic (IVD) devices like this one, typically don't include the detailed statistical acceptance criteria or the full study reports. Instead, they focus on demonstrating substantial equivalence to a predicate device.

However, I can extract the information that is present and highlight what is not explicitly stated in this type of document, but would typically be part of the full submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific statistical acceptance criteria (e.g., % within +/- X mg/dL or % within +/- Y%). It states the general conclusion that the device "performs as intended" and "can produce results that are substantially equivalent to results obtained on the predicate devices."

For blood glucose meters, typical acceptance criteria often align with ISO 15197 for accuracy, which specifies standards like:

• ≥95% of results for glucose concentrations < 75 mg/dL differ by no more than ± 15 mg/dL from the reference measurement.
• ≥95% of results for glucose concentrations ≥ 75 mg/dL differ by no more than ± 20% from the reference measurement.

For β-ketone meters, similar accuracy criteria would be applied.

Since the specific criteria and detailed performance statistics (e.g., bias, precision, linearity over a range) are not provided in this summary, a table cannot be fully populated. The document only offers a high-level summary of the performance.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The performance of the Nova Max Plus Blood Glucose and B-Ketone Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users."

• Sample Size: Not explicitly stated. This would be detailed in the full performance study report within the 510(k) submission.
• Data Provenance: The studies were conducted in "the laboratory and in clinical settings" by "healthcare professionals and lay users." The country of origin is not specified, but Nova Biomedical Corporation is a U.S. company, suggesting the studies likely occurred in the U.S. The studies are implicit retrospective in the sense that they are evaluating a device that has already been developed and tested, but data collection would be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts/Reference Methods: Not explicitly stated. For IVD devices, "ground truth" (or reference method) for glucose and β-ketone is typically established using a high-precision laboratory analyzer (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer for glucose, and a specific enzymatic method for β-ketone), rather than human experts reviewing images or clinical cases. These reference methods are themselves subject to strict quality control and calibration.
• Qualifications of Experts (if applicable): Not applicable in the traditional sense of human readers. The "experts" are the validated laboratory reference instruments and the trained personnel operating them according to standard protocols.

4. Adjudication Method for the Test Set

• Not applicable for this type of IVD device where ground truth is established by a reference laboratory method. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human readers interpret data, and discrepancies need to be resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists reading X-rays). For a blood glucose and ketone monitoring system, the "reader" is essentially the device itself, and its performance is compared directly to a reference method, not to how it aids human interpretation of complex data.

6. Standalone Performance Study

• Yes, a standalone study was done. The entire "Performance Studies" section describes the evaluation of the device as a standalone system. The statement, "The studies demonstrated that lay users can obtain blood glucose and blood ß-Ketone results that are substantially equivalent to the current methods for blood glucose and blood ß-ketone measurements," directly refers to the device's independent performance.

7. Type of Ground Truth Used

• Reference Laboratory Methods: The ground truth for both glucose and β-ketonetest results would be established by highly accurate and precise laboratory reference instruments. The text mentions "current methods for blood glucose and blood ß-ketone measurements" and that the "Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods," strongly implying the use of such reference methods.

8. Sample Size for the Training Set

• Not Applicable/Not Explicitly Stated. For a traditional electrochemical blood glucose/ketone meter, there isn't a "training set" in the sense of machine learning algorithms that require vast amounts of data to learn patterns. The device's calibration curve and algorithms are developed through R&D and then validated. If any specific data were used for initial calibration curve development, that information is not provided here.

9. How Ground Truth for the Training Set Was Established

• Not Applicable/Not Explicitly Stated. As mentioned above, a "training set" with established ground truth is not typically relevant for this type of IVD device in the same way it is for AI/ML-driven devices. Device calibration and algorithm development would rely on controlled solutions and known concentrations, not a "ground truth" derived from patient samples with expert consensus.

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