(242 days)
The CLINITEK Novus® Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument. The CLINITEK Novus analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus Cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus 10 Urinalysis Cassette is intended for the seniquantitative measurement of the following parameters in urine: bilirubin, blood (occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein, color, and urobilinogen.
These measurements are used to assist diagnosis in the following areas:
- · Carbohydrate metabolism (such as diabetes mellitus)
- · Kidney function
- · Liver function
- · Metabolic disorders
- · Urinary tract infection
For in vitro diagnostic use.
The CLINITEK Novus® Calibration Kit is intended to be used with the CLINITEK Novus Urinalysis Cassette to calibrate the CLINITEK Novus Automated Urine Chemistry analyzer. This product is for professional in vitro diagnostic use.
The CLINITEK Novus® system is a fully automated urine chemistry analyzer that is designed for use with the CLINITEK Novus® 10 Urinalysis Cassette. The analyzer automates the process of urine strip testing by dispensing urine samples onto a test pad, and then by reading the color and intensity of light reflected from the reacted test pads, converts the results into clinically meaningful units.
Test results from the test pads are qualitative and semi-quantitative; specific gravity is measured by a refractometer assembly.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% agreement"). However, it does present the results of comparison studies against a predicate device and states that "The results for overall percent agreement and within one level agreement met acceptance criteria." This implies that acceptable thresholds were achieved. Based on the presented data, we can infer the achieved performance. For specific analytes, the values vary, but they consistently show high exact match and very high agreement within +/- 1 block.
| Analyte | Performance Metric | CLINITEK Novus Result (All Sites Combined) | Implied/Achieved Acceptance Criteria (based on "met acceptance criteria") |
|---|---|---|---|
| Bilirubin | % exact match (range) | 64.4% - 99.8% | High % (exact match) |
| % within 1 block (range) | 98.2% - 100.0% | Very high % (within 1 block) | |
| Blood | % exact match (range) | 81.5% - 97.8% | High % (exact match) |
| % within 1 block (range) | 100.0% (except one at 99.7%) | Very high % (within 1 block) | |
| Glucose | % exact match (range) | 88.5% - 99.6% | High % (exact match) |
| % within 1 block (range) | 100.0% | Very high % (within 1 block) | |
| Ketone | % exact match (range) | 88.2% - 100.0% | High % (exact match) |
| % within 1 block (range) | 99.2% - 100.0% | Very high % (within 1 block) | |
| Leukocyte | % exact match (range) | 81.1% - 96.6% | High % (exact match) |
| % within 1 block (range) | 99.9% - 100.0% | Very high % (within 1 block) | |
| Nitrite | % exact match (range) | 99.3% - 100.0% | High % (exact match) |
| % within 1 block (range) | 100.0% | Very high % (within 1 block) | |
| pH | % exact match (range) | 45.4% - 99.8% | High % (exact match) |
| % within 1 block (range) | 97.5% - 100.0% | Very high % (within 1 block) | |
| Protein | % exact match (range) | 89.9% - 98.7% | High % (exact match) |
| % within 1 block (range) | 99.9% - 100.0% | Very high % (within 1 block) | |
| Urobilinogen | % exact match (range) (sites 1-3) | 85.6% - 99.9% | High % (exact match) |
| % within 1 block (range) (sites 1-3) | 100.0% | Very high % (within 1 block) | |
| Urobilinogen | % exact match (range) (site 4) | 93.8% - 100.0% | High % (exact match) |
| % within 1 block (range) (site 4) | 100.0% | Very high % (within 1 block) | |
| Specific Gravity | R2 | 0.983 | High R2 (correlation) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For the method comparison study (comparing CLINITEK Novus to the predicate CLINITEK Atlas), up to 2773 specimens were tested across 3 sites for most analytes.
- For Urobilinogen, an additional fourth site was involved due to a high number of contrived samples in the initial three sites. This fourth site tested 261 samples (187 negative, and then 48, 10, 12, 4 for various positive levels).
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted "across 3 sites" (and later a fourth), implying a multi-center study within the scope of the device manufacturer's operations/clinical trials. It is a prospective comparison study as it compared the new device (CLINITEK Novus) against an existing predicate device (CLINITEK Atlas) using actual patient specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The context of this device being an automated urine chemistry analyzer comparing its readings to a predicate automated urine chemistry analyzer suggests that the "ground truth" for the test set was established by the results from the predicate device (CLINITEK Atlas), not human experts. Therefore, the concept of a number of experts and their qualifications for establishing ground truth is not directly applicable in this context. The predicate device's established performance serves as the reference.
4. Adjudication Method for the Test Set
Since the comparison is primarily between two automated devices, and the "ground truth" is derived from the predicate device's readings, a typical adjudication method involving human readers (like 2+1 or 3+1 consensus) is not applicable. The data presented is a direct comparison of the readings obtained from the CLINITEK Novus analyzer against the readings obtained from the CLINITEK Atlas analyzer.
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?
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance was not performed. This device is an automated in vitro diagnostic (IVD) analyzer, not an AI-powered image analysis tool meant to assist human readers. Its primary function is to automatically measure chemical parameters in urine.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
Yes, the performance reported is a standalone performance of the CLINITEK Novus Automated Urine Chemistry Analyzer. It assesses the device's ability to accurately measure urine parameters independently, by comparing its results directly to those of a predicate automated device. There is no human-in-the-loop component in the reported performance evaluation.
7. The Type of Ground Truth Used
The primary "ground truth" used for the method comparison study was the results obtained from the predicate device, the CLINITEK Atlas Automated Urine Chemistry Analyzer. For the detection limit study, "ground truth" was established by spiking negative pooled human urine with known quantities of analytes.
8. The Sample Size for the Training Set
The document describes studies comparing the new device to a predicate device and analytical performance characteristics. It does not explicitly mention a "training set" or a machine learning/AI model training process for this IVD device. The description focuses on demonstrating substantial equivalence to a predicate device through analytical and method comparison studies. If the device uses algorithms derived from prior data, that information is not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly mentioned in the context of machine learning/AI for this device, the method for establishing its ground truth is not applicable/not provided in this document. The device's operation appears to be based on established reflectance photometry and refractive index principles for chemical analysis, rather than a learned model from a training set.
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.