(155 days)
The URiSCAN S-300 Semi-Automated Urine Chemistry Analyzer is a urine analyzer for detection of Occult Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, pH, Specific Gravity, Leukocytes and Ascorbic Acid in urine specimens through the reflectance method.
The URISCAN S-300 Semi-Automated Urine Chemistry Analyzer is a line operated unit which translates color and intensity of light reflected from reacted reagent pads into clinical units and displays the results. The instrument is specifically designed to "read" YEONGDONG URiSCAN urinalysis reagent strips (See K952307). The URiSCAN S-300 Semi-Automated Urine Chemistry system includes tests for the following physical properties and chemical constituents of urine: specific gravity, pH, Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, Leukocytes and Ascorbic Acid. The instrument uses a light source produced by cold fluorescent lamp.
The provided document describes the URiSCAN S-300 Semi-Automated Urine Chemistry Analyzer and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with numerical targets or detailed results from a study demonstrating the device meets such criteria. The information is high-level and focuses on the equivalence to existing devices rather than a detailed performance study against pre-defined acceptance metrics.
Below is an attempt to structure the information based on the request, acknowledging the limitations of the provided text.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) summary for the URiSCAN S-300 Semi-Automated Urine Chemistry Analyzer describes its analytical performance evaluation to demonstrate substantial equivalence to legally marketed predicate devices. However, it does not explicitly state pre-defined numerical "acceptance criteria" for precision, accuracy, or linearity. Instead, the study's goal appears to be demonstrating "similar" performance to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit numerical acceptance criteria are not provided in the document, this table will reflect the general nature of the reported performance (similarity to predicate devices) for the evaluated metrics.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated as Numerical Targets) | Reported Device Performance |
|---|---|---|
| Precision | Performance should be similar to predicate devices | Evaluated for precision, described as performing "similarly to the predicate devices." |
| Accuracy | Performance should be similar to predicate devices | Evaluated for accuracy, described as performing "similarly to the predicate devices." |
| Linearity | Performance should be similar to predicate devices | Evaluated for linearity, described as performing "similarly to the predicate devices." |
| Correlation | Performance should be comparable to predicate devices | Evaluated for correlation with the Ames/Miles, Inc. (Bayer) Clinitek 200 Semi-automated Urinalysis System and the Boehringer Mannheim Chemstrip Super UA Urine Analyzer predicate devices. Found to perform "similarly to the predicate devices." Comparative clinical evaluations were also conducted using a Clinitek 200+ system as a reference analyzer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical tests on patient urine specimens. It mentions tests were conducted on "patient urine specimens" and "at two different laboratories."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: "Patient urine specimens." The document does not specify the country of origin of the data, but the submitter is from Seoul, Korea, and the 510(k) summary was prepared in the US, so it's possible the data could be from either or both regions. The study appears to be prospective in nature, as it describes "clinical tests performed" and "comparative clinical evaluations."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of human experts to establish ground truth. The comparison is made against existing predicate automated urinalysis systems (Ames/Miles, Inc. (Bayer) Clinitek 200 Semi-automated Urinalysis System, Boehringer Mannheim Chemstrip Super UA Urine Analyzer, and Clinitek 200+ system). Therefore, the "ground truth" for the test set appears to be derived from these established, legally marketed devices.
4. Adjudication Method for the Test Set
No adjudication method involving human experts is described, as the comparison is against predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device is a "Semi-Automated Urine Chemistry Analyzer," implying it performs the analysis rather than assisting human readers directly in interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was conducted. The "analytical performance of the URiSCAN S-300 Semi-Automated Urine Chemistry Analyzer on patient urine specimens was evaluated for precision, accuracy, linearity and correlation." This refers to the device's performance as a standalone automated system.
7. Type of Ground Truth Used
The ground truth for the performance evaluation was established by comparison to legally marketed predicate devices, specifically:
- Ames/Miles, Inc. (Bayer) Clinitek 200 Semi-automated Urinalysis System (K842237)
- Boehringer Mannheim Chemstrip Super UA Urine Analyzer (K934042)
- Clinitek 200+ system (used as a reference analyzer in comparative clinical evaluations)
These predicate devices serve as the "true" or reference measurements against which the URiSCAN S-300's results were compared.
8. Sample Size for the Training Set
The document does not mention a "training set" or a sample size for one. This device is a semi-automated chemical analyzer, not a machine learning or AI-based diagnostic tool that typically requires a separate training set. Its technology relies on reflectance spectrophotometry rather than pattern recognition or AI algorithms learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described.
§ 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.