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510(k) Data Aggregation
(368 days)
The Nova Max Uric Acid Monitoring System consists of Nova Max Uric Acid Monitor, Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions. The Nova Max Uric Acid Monitoring System is intended to the quantitative measurement of Uric Acid in fresh capillary whole blood obtained from the fingertip of gout patients. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of Uric Acid control. It is intended for use by patients undergoing treatment for gout or the order of a treating healthcare professional. This system should not be used to alter gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional. This system should only be used with single-use, auto-disabling Lancing Devices. It should only be used with Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions.
The Nova Max Uric Acid Monitoring System uses selective mediated enzymatic action (uricase biosensor) to generate current across the electrodes. The current generated is proportional to the concentration of Uric Acid in the whole blood sample. The device, which is amperometric, measures the Uric Acid concentration in the whole blood sample by measuring the amount of current that was generated and flows through the electrodes on the Test Strips.
The Nova Max Uric Acid Monitoring System is comprised of Nova Max Uric Acid Test Strips, a portable handheld Nova Max Uric Acid Monitor, and Nova Max Uric Acid Control Solutions.
Monitor Power Supply: The monitor uses single (3V) lithium, non-rechargeable battery. The battery life is approximately 1,000 tests.
No-Coding System: The user is not required to enter a Test Strip lot-specific Calibration Code into the monitor by pressing a button or by inserting a Code Key.
Uric Acid Control Solutions are aqueous assayed solutions, containing buffered Uric Acid, preservatives, FD & C dye, and viscosity additive. They contain no products of human origin. There are three levels of controls (level 1, 2, and 3).
Safety Lancets are provided as an accessory to the Nova Max Uric Acid Monitoring System. They are commercially available single-use, auto disabling sterilized Lancing Devices.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:
Device Name: Nova Max Uric Acid Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Study Accuracy | |
| Linear Regression Correlation Coefficient (R²) ≥ 0.95 | The "Clinical Study Conclusion" states: "The results of the layperson clinical study confirmed that the Nova Max Uric Acid Monitoring System is safe and effective for the intended use populations (persons diagnosed with Gout) and the Nova Max Uric Acid Monitoring System is substantially equivalent to the predicate device." While a specific R² value isn't explicitly stated in the summary, the conclusion implies this criterion was met. |
| Linear Regression Slope of 0.94 - 1.06 | As above, the clinical study conclusion indicates this criterion was met, even if the specific numerical result is not in the provided text. |
| Bench Testing (Sample Criteria) | |
| Precision: Within-run CV% < 10% | Reported in Table 2-1 as "Within run CV% < 10%." |
| Measuring Range: 3-18 mg/dL | Reported in Table 2-1 as "3-18 mg/dL." |
| Human Factors Study (Ease-of-Use/Comprehension) | |
| Subjects' ability to demonstrate understanding of system/use (successful performance of a Uric Acid whole blood capillary fingerstick test and a Uric Acid control solution test) | "Conclusions were based on the subjects' ability to demonstrate by action, their understanding of the system, and their understanding of how to use the system (Successful performance of a Uric Acid whole blood capillary fingerstick test and a Uric Acid control solution test)..." The study "demonstrates ease-of-use of the device as well as effectiveness of the Nova Max Uric Acid Monitoring System instructions for use." |
| Comprehension of contents of instructions for use | "Conclusions were based on...comprehension of the contents of the instructions for use..." The study "demonstrates...effectiveness of the Nova Max Uric Acid Monitoring System instructions for use." |
| User assessment questionnaire of ease-of-use | "The response to the questionnaire indicates that the participants were comfortable with the Nova Max Uric Acid Monitoring System, and lead to the conclusion that a typical layperson diagnosed with gout will find the monitor easy to operate, and the labeling easy to understand." |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set:
- Phase 1: 120 layperson subjects previously diagnosed with gout.
- Phase 2: An additional 25 layperson subjects previously diagnosed with gout (total 145 subjects for clinical studies).
- Human Factors Study Test Set: 120 layperson intended use subjects previously diagnosed with gout.
- Data Provenance: The studies were conducted in the U.S. (explicitly stated for the Human Factors study, implied for the clinical study given the FDA submission). The studies were prospective, involving direct testing of subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth. The ground truth was established by comparison to a legally marketed predicate device:
- Clinical Study:
- Phase 1: Comparison to measurements from a venous (lithium heparin) whole blood sample from the same patient by the Siemens Dimension RxL Max Clinical Chemistry System (K043546).
- Phase 2: Comparison with venous plasma specimens measured on the URCA method on the Siemens Dimension RxL Max Clinical Chemistry System (predicate device, reference method).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for establishing ground truth from the reference methods (Siemens Dimension RxL Max Clinical Chemistry System). In this type of diagnostic device submission, the predicate device itself serves as the 'gold standard' reference, and no expert adjudication of its results would typically be required or performed beyond its own validated performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This is an in-vitro diagnostic (IVD) device, and the performance is evaluated by comparing its quantitative measurements to a reference method, not by assessing human reader improvement with AI assistance. The "Human Factors Study" assesses user performance and comprehension, which is related to human interaction with the device, but it is not an MRMC study in the context of image interpretation or other similar diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance evaluation for this IVD device is its standalone performance in measuring uric acid. The "Clinical Study" directly compares the device's measured uric acid levels to those obtained by a reference method (the predicate device), demonstrating the algorithm's accuracy in producing a numerical result without direct human interpretation influencing the measurement itself (though human interaction is required for sample collection and initiation). The Human Factors study assesses the user's ability to operate the device correctly, which is a separate but critical component of the overall system's effectiveness.
7. The Type of Ground Truth Used
The ground truth used was comparative measurement against a validated predicate device/reference method: the Siemens Dimension RxL Max Clinical Chemistry System (K043546). This is a common approach for establishing substantial equivalence for new IVD devices.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate "training set" or its sample size. For IVD devices like this one, studies typically focus on demonstrating performance on a test set (clinical and bench studies) rather than describing a separate training phase for an AI/ML model. The device's underlying technology is described as an "enzymatic biosensor" and amperometric measurement, implying a biochemical and electrical principle rather than a machine learning algorithm that requires extensive "training data" in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described (as detailed in point 8), the method for establishing its ground truth is also not applicable/not provided in this document.
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