(371 days)
The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.
CYBOW Reader 300, 720 are reflectance photometer. The strip is illuminated by white light, and there flected light from the strip is detected by a color Image Sensor. The RGB signals are digitized, and this digitized image is evaluated by the processor. The intelligent image analyzer SW locates the strip and the pads, and based on these color data the parameter values are determined. The results with the date and time of the measurement as well as the sequence number and the ID are stored and printed out by the internal printer.
The provided document is a 510(k) summary for the DFI Co., Ltd's CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers. It describes the device, its intended use, and indicates substantial equivalence to a predicate device based on non-clinical studies.
However, the summary does not explicitly state specific acceptance criteria (e.g., performance thresholds like sensitivity, specificity, accuracy targets) for the device. Instead, it broadly states that non-clinical studies for analytical performance (precision, linearity, reportable range, detection limit, analytical specificity/limitation) and comparison studies were conducted. The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that its performance met unstated internal criteria for equivalence.
Additionally, the document does not provide the detailed results of the device performance for direct comparison against any acceptance criteria. It only mentions that a "Comparison study Method comparison with predicate device, clinical study" was performed according to NCCLS EP9A guidelines.
Given these limitations, I will extract and infer information from the provided text to fulfill the request as best as possible.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific numerical acceptance criteria are not explicitly stated in the provided 510(k) summary. The document only mentions that analytical performance and comparison studies were conducted to demonstrate substantial equivalence to the predicate device.
Inferred Acceptance Criteria (based on the context of a 510(k) submission for substantial equivalence):
- Analytical Performance: Performance (precision, reproducibility, linearity, assay reportable range, detection limit, analytical specificity/limitation) should be comparable to or not worse than the predicate device.
- Method Comparison: Agreement with the predicate device should be within acceptable clinical and analytical limits, as defined by standard guidelines like NCCLS EP9A.
Reported Device Performance:
The document states that a "Non-Clinical study was conducted on the CYBOW Reader 300 and CYBOW Reader 720" including "Analytical performance" and a "Comparison study Method comparison with predicate device, clinical study."
The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that the performance met unstated criteria. No specific numerical performance results (e.g., correlation coefficients, bias, accuracy rates) are provided in this summary.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Analytical Performance: Comparable to or not worse than predicate device for: | Analytical performance studies were conducted including precision/reproducibility, linearity/assay reportable range, detection limit, and analytical specificity/limitation of test. The conclusion states the device is "safe and effective and substantially equivalent" to the predicate, implying these criteria were met. No specific performance data is provided. |
| - Precision / Reproducibility | |
| - Linearity / Assay Reportable Range, Detection Limit | |
| - Analytical Specificity / Limitation of Test | |
| Method Comparison: Agreement with predicate device within acceptable clinical/analytical limits (per NCCLS EP9A). | Comparison study was conducted: "Method comparison with predicate device, clinical study" following "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A." The conclusion of "substantial equivalence" suggests acceptable agreement. No specific comparison data is provided. |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set:
- Site A (Samsung Hospital): 255 samples
- Site B (Authoritative local university hospital at national Univ. of Pusan): 280 samples
- Site C (Authoritative local university hospital at national Univ. of Dong Ai): 332 samples
- Total Samples (across three sites): 867 samples (assuming these are distinct samples rather than samples per parameter, which is typical for method comparison studies)
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Data Provenance:
- Country of Origin: Based on the names of the hospitals (Samsung Hospital, National Univ. of Pusan, National Univ. of Dong Ai) and the submitter's address (Kimhae-city, Gyung-nam, Korea; Seoul, Korea), the data originated from South Korea.
- Retrospective or Prospective: The document implies prospective collection for the purpose of the study. It states, "Three independent laboratory evaluations of the New Device and Predicative Device were conducted... for 20 days." And also, "Three operators, reflective of the intended users of the devices, performed the testing at each site." This strongly suggests the samples were run during this 20-day study period, rather than being historical retrospective data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or a specific ground truth establishment process for the test set in the way one might see for imaging or diagnostic interpretation devices.
For a urine chemistry analyzer comparing to a predicate, the "ground truth" for the test set is typically established by the measurement results from the predicate device itself, or a recognized reference method if one exists and is specified (which is not the case here).
Therefore:
- Number of Experts: Not applicable in the context of this type of comparison study, as the ground truth is the predicate device's measurement.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. This is expected for a method comparison study of a quantitative/semi-quantitative analyte measurement device. The comparison method typically involves statistical analysis (e.g., regression, bias plots) between the new device's readings and the predicate device's readings, rather than a human adjudication process for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Was an MRMC study done? No. The study described is a method comparison study between an automated device and a predicate device, focusing on analytical performance and agreement on patient samples. While "Three operators, reflective of the intended users of the devices, performed the testing at each site," this is to assess reproducibility and routine use, not a multi-reader (human interpretation) comparative effectiveness study of diagnostic accuracy.
- Effect Size of Human Readers Improvement with AI vs. Without AI: Not applicable, as this was not an AI-assisted human interpretation study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone study was done. The CYBOW Reader 300 and CYBOW Reader 720 are described as "reflectance photometer" devices with "intelligent image analyzer SW" that "locates the strip and the pads, and based on these color data the parameter values are determined." The non-clinical studies, including analytical performance and method comparison, evaluate the performance of these devices in a standalone manner (the algorithm/system itself, without human interpretation of the final result). The human operators are involved in running the device and handling samples, but the "performance" directly refers to the device's measured output.
7. The Type of Ground Truth Used
For the comparison study, the ground truth was the measurement results from the predicate device (Clinitek 200+, 500). The evaluation explicitly states it followed "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A," which is a standard for comparing a new method to an existing method (the predicate) using patient samples.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for the training set. For reflectance photometers with "intelligent image analyzer SW," a training set would typically be used during the development phase to optimize the algorithms for color interpretation. However, this 510(k) summary focuses on the validation of the final product.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. This information is generally part of the device's internal development process and is not typically detailed in a 510(k) summary, which focuses on the validation of the finished device.
§ 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.