(119 days)
The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.
Nova StatSensor Creatinine Test Strips are intended for use only with the StatSensor Creatinine Hospital Meter for quantitative tests. The Nova StatSensor Creatinine Hospital Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatSensor Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only).
Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter.
Nova StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine Hospital Meter System. There are five levels of Linearity Solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).
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Here's the analysis of the provided text regarding the Nova StatSensor Creatinine Hospital Meter, focusing on acceptance criteria and study details.
Important Note: The provided document is an FDA 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed study write-up that would typically include acceptance criteria and specific performance data. Therefore, I can only extract information that is explicitly stated or can be reasonably inferred from this type of regulatory document. Many of the requested details (sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not present in this document.
Acceptance Criteria and Device Performance Study Analysis
Based on the provided documents (FDA 510(k) clearance letter K070068 and Indications for Use), the Nova StatSensor Creatinine Hospital Meter is cleared for marketing as it has been deemed "substantially equivalent" to legally marketed predicate devices. This indicates that the device met the performance requirements necessary to demonstrate this substantial equivalence. However, the exact numerical acceptance criteria and the detailed study design proving those criteria are not present in these documents.
Missing Information: A typical detailed study report would include specific numerical targets for accuracy, precision, linearity, etc., and the results obtained against those targets. This document only confirms that such testing must have occurred to achieve 510(k) clearance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from predicate/general regulatory standards) | Reported Device Performance (as inferred from 510(k) clearance) |
|---|---|---|
| Accuracy / Bias | Must be demonstrably equivalent to a legally marketed predicate device for creatinine measurement in whole blood. | Deemed substantially equivalent to predicate devices; performs with acceptable accuracy for its intended use (quantitative measurement of creatinine in capillary, venous, and arterial whole blood, providing plasma equivalent results). |
| Precision | Must be within acceptable limits for a quantitative creatinine assay. | Achieved sufficient precision to demonstrate substantial equivalence. |
| Linearity | Must demonstrate linearity across the stated measurement range. | Linearity kit solutions are available, implying successful linearity testing across 5 levels. |
| Interfering Substances | (Not specified in document, but generally required) Minimal interference from common endogenous and exogenous substances. | Implied to be acceptable based on 510(k) clearance. |
| Reproducibility | (Not specified in document, but generally required) Consistent results across different operators, lots, and instruments. | Implied to be acceptable based on 510(k) clearance. |
| Calibrated to Plasma Equivalency | Must provide plasma equivalent results. | Explicitly stated: "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods." |
(Note: The "Acceptance Criteria" column is inferred from the general requirements for 510(k) cleared IVD devices and the nature of the predicate determination. The "Reported Device Performance" column states what the FDA's clearance implies, rather than specific numerical outcomes, as these are not provided.)
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): Not specified in the provided documents.
- Data Provenance: Not specified in the provided documents (e.g., country of origin, retrospective or prospective). Safety and effectiveness data, likely gathered prospectively from clinical or laboratory studies in the US or other regions, would have been submitted to the FDA as part of the 510(k) application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For an in vitro diagnostic device measuring a chemical analyte like creatinine, the "ground truth" would typically be established by a reference method run by trained laboratory personnel in a CLIA-certified or equivalent laboratory, not necessarily "experts" in the sense of clinicians reviewing images, but rather highly skilled laboratory technicians and clinical chemists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. This is generally not applicable in the same way for quantitative chemical assays as it would be for subjective interpretations (e.g., radiology reads). The "ground truth" for a chemical assay is typically a quantitative result from a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
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MRMC Study: No, an MRMC study is not applicable for this type of device. MRMC studies are used for devices that assist human interpretation of diagnostic images (e.g., radiologists interpreting X-rays or MRI scans). The Nova StatSensor Creatinine Hospital Meter is a quantitative assay device; it measures a biochemical marker directly, rather than assisting human readers in interpreting complex data.
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Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed or is relevant for this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: Yes, the performance testing for an in vitro diagnostic device like this is inherently "standalone" in the sense that the device measures creatinine directly without human interpretive intervention. The performance characteristics (accuracy, precision, linearity, etc.) are evaluated based on the device's output compared to a reference method. There isn't an "algorithm" in the same sense as an AI image interpretation tool, but rather the electrochemical detection and calculation within the meter.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Reference laboratory method: For quantitative diagnostic devices like this, the ground truth is established by a highly accurate and precise reference method for creatinine measurement (e.g., enzymatic or HPLC-based methods) performed in a clinical laboratory.
- The document states, "The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods," indicating that established laboratory methods serve as the standard for comparison.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not specified in the provided documents.
- For a chemical assay device, "training set" doesn't apply in the same way as for machine learning algorithms. Instead, there would be internal development and verification studies using various samples to optimize the assay chemistry, electrode design, and instrument calibration before formal validation studies. The number of samples used in these internal studies is generally proprietary and not disclosed in regulatory summaries.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified.
- Similar to the test set, during the development and calibration phases, the ground truth would have been established using reference laboratory methods for creatinine measurement on various samples to guide the optimization and calibration of the Nova StatSensor system.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.