(431 days)
The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
This document describes the performance of the TC-Thunderbolt Automated Urine Analyzer System, an in vitro diagnostic device for semi-quantitative analysis of urine chemistry. The studies presented focus on the analytical performance of the device and its associated test strips (TC-Thunderbolt URS-10 strips) rather than human-in-the-loop performance with an AI. Therefore, sections related to human reader improvement with AI assistance (MRMC studies) and expert consensus in the typical sense for AI model ground truth are not directly applicable to this type of device submission.
Here's a breakdown of the requested information based on the provided text, focusing on the device's analytical performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by the results of the precision and method comparison studies, generally aiming for high agreement with either the expected control values or a predicate device. The tables below summarize the reported device performance for selected analytes from the precision (within-run and run-to-run) and method comparison studies.
Precision Study Acceptance Criteria & Performance (Within-Run & Run-to-Run for Urine Controls):
The acceptance criteria for precision studies are generally for high exact match agreement and 100% agreement within +/- one color block.
| Analyte | Study Type | Target Level | Acceptance Criteria (Exact Match) | Reported Performance (% Exact Match) | Acceptance Criteria (+/- Color Block) | Reported Performance (% +/- Color Block) |
|---|---|---|---|---|---|---|
| Glucose | Within Run | 500 mg/dL | High Agreement (e.g.,>95%) | 96.67% | 100% | 100% |
| Within Run | 100 mg/dL | High Agreement (e.g.,>95%) | 96.67% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 500 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 100 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Bilirubin | Within Run | Moderate | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | Small | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Moderate | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Small | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Ketone | Within Run | 40 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | 40 mg/dL | High Agreement (e.g.,>95%) | 98.83% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 40 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 40 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Specific Gravity | Within Run | 1.015 | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | 1.015 | High Agreement (e.g.,>95%) | 95% | 100% | 100% | |
| Within Run | 1.005 | High Agreement (e.g.,>95%) | 96.67% | 100% | 100% | |
| Run to Run | 1.015 | High Agreement (e.g.,>95%) | 98.83% | 100% | 100% | |
| Run to Run | 1.015 | High Agreement (e.g.,>95%) | 93.34% | 100% | 100% | |
| Run to Run | 1.005 | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Blood | Within Run | Moderate | High Agreement (e.g.,>95%) | 98.34% | 100% | 100% |
| Within Run | Trace | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Moderate | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Trace | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Nitrite | Within Run | Positive | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | Positive | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Positive | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Positive | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Protein | Within Run | 300 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 300 mg/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Urobilinogen | Within Run | 8 EU/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | 0.2 EU/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | 0.2 EU/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 8 EU/dL | High Agreement (e.g.,>95%) | 98.83% | 100% | 100% | |
| Run to Run | 0.2 EU/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 0.2 EU/dL | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Leukocyte | Within Run | Moderate | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | Small | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Moderate | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | Small | High Agreement (e.g.,>95%) | 96.67% | 100% | 100% | |
| Run to Run | Negative | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| pH | Within Run | 7.5 | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
| Within Run | 7.5 | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Within Run | 6.5 | High Agreement (e.g.,>95%) | 96.67% | 100% | 100% | |
| Run to Run | 7.5 | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 7.5 | High Agreement (e.g.,>95%) | 100% | 100% | 100% | |
| Run to Run | 6.5 | High Agreement (e.g.,>95%) | 100% | 100% | 100% |
Method Comparison Study Acceptance Criteria & Performance (vs. Predicate Device):
The acceptance criteria for method comparison studies are generally for high overall agreement, with a specific note for SG.
| Analyte | Acceptance Criteria (Overall Exact Match) | Reported Overall Exact Match | Acceptance Criteria (Overall +/- Color Block) | Reported Overall +/- Color Block |
|---|---|---|---|---|
| Glucose | High Agreement (e.g., >95%) | 98.36% | High Agreement (e.g., 100%) | 100% |
| Bilirubin | High Agreement (e.g., >95%) | 99.59% | High Agreement (e.g., 100%) | 100% |
| Ketone | High Agreement (e.g., >95%) | 97.74% | High Agreement (e.g., 100%) | 100% |
| Specific Gravity | High Agreement (e.g., >75%) | 79.88% | +/- 0.005 (note) | 99.18% |
| Blood | High Agreement (e.g., >95%) | 95.48% | High Agreement (e.g., 100%) | 100% |
| Protein | High Agreement (e.g., >95%) | 97.95% | High Agreement (e.g., 100%) | 100% |
| Urobilinogen | High Agreement (e.g., >95%) | 95.69% | High Agreement (e.g., 100%) | 100% |
| pH | High Agreement (e.g., >85%) | 86.45% | High Agreement (e.g., >99%) | 99.59% |
| Nitrite | High Agreement (e.g., >99%) | 99.79% | High Agreement (e.g., 100%) | 100% |
| Leukocyte | High Agreement (e.g., >95%) | 96.71% | High Agreement (e.g., 100%) | 100% |
2. Sample Size Used for the Test Set and Data Provenance
Precision Study (Test Set):
For Within Run precision: 60 strips per control level (20 replicates x 1 day x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
For Run to Run precision: 60 strips per control level (2 replicates x 2 runs x 5 days x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
Data Provenance: Not explicitly stated for all samples, but the "Method Comparison Study Summary" states: "This comparison study testing was performed at Teco Diagnostics, Anaheim CA in United States." It also mentions "The urine samples for analysis in these method comparison studies were provided by external clinical sites." This implies a prospective data collection for the method comparison, and likely also for the precision studies, as real-time control solutions were used.
Method Comparison Study (Test Set):
A total of 487 urine samples were used for the method comparison study.
Data Provenance: The study was performed at Teco Diagnostics, Anaheim, CA, United States. Samples were collected from external clinical sites. These could be considered a mix of retrospective and prospective, as some samples might have been collected specifically for the study (prospective), and others could have been existing samples (retrospective), but the description implies a prospective approach to sample collection and testing for the study. Spiked samples were also prepared.
Sensitivity/Cutoff Point Determination Study & Linearity Study (Test Set):
For Sensitivity: 21 data points for each level (7 strips x 3 operators/strip lots). This study used spiked urine samples.
For Linearity: 21 measurements for every sample tested (7 strips x 3 operators/strip lots). This study used negative urine and spiked negative urine.
Data Provenance: Performed at Teco Diagnostics, Anaheim, CA, United States. Samples were negative urine, with many spiked to achieve various concentrations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in vitro diagnostic device, "ground truth" is typically established by:
- Reference materials/control solutions: For precision studies, commercially available urine control solutions with confirmed target analyte concentrations were used.
- Comparative method (Predicate Device or Reference Method): For method comparison, the predicate device (Uritek-720+ Urine Analyzer) served as the comparative method against which the new device's performance was evaluated.
- Known concentrations: For sensitivity and linearity studies, samples were prepared by spiking known concentrations of analytes into negative urine. For pH, a pH meter confirmed results, and for Specific Gravity, a clinical, handheld refractometer confirmed values.
Therefore, the ground truth is established by analytical reference methods and known chemical concentrations, rather than human expert reads of images. There is no mention of human experts establishing ground truth in the context of image interpretation or reading. The studies mentioned involve operators performing tests, but their role is to execute the protocol and collect data, not to adjudicate ground truth. The number of operators (3) is mentioned for precision and sensitivity/linearity studies, indicating consistency checks across different users of the device.
4. Adjudication Method for the Test Set
Adjudication as typically understood in the context of human reader disagreement for AI models is not directly applicable here. The "ground truth" for these analytical tests is based on the known concentrations of controls, the results from a predicate device, or measurements by reference instruments (pH meter, refractometer). Discrepancies in device readings are analyzed as agreement percentages (exact match and +/- color block) against these pre-established analytical references, rather than being arbitrated by human experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This submission is for an automated in vitro diagnostic device (urine analyzer) that produces semi-quantitative results by measuring chemical reactions on test strips. It is not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies are essentially standalone performance evaluations of the automated device (TC-Thunderbolt Automated Urine Analyzer System). While operators conduct the tests, the output is generated by the instrument's sensing and processing of the chemical reactions on the strips. The tables presented show the performance of the device itself (e.g., % agreement with controls or predicate device), representing its standalone analytical capability.
7. The Type of Ground Truth Used
The types of ground truth used are:
- Defined Control Solutions/Reference Materials: For precision studies, commercially available urine control solutions with certified analyte concentrations were used.
- Predicate Device Gold Standard: For method comparison, the Uritek-720+ Urine Analyzer (the predicate device) served as the reference against which the new device was compared.
- Known Chemical Concentrations: For sensitivity/cutoff point determination and linearity studies, samples were prepared by spiking urine with precise, known concentrations of analytes.
- Reference Instruments: For pH, a pH meter was used as the ground truth. For specific gravity, a clinical, handheld refractometer was used as the ground truth.
8. The Sample Size for the Training Set
This document only describes analytical performance studies for a medical device submitted for 510(k) clearance, which demonstrates substantial equivalence to a predicate device. It does not provide information about a "training set" in the context of machine learning. The device's operation is based on established chemical principles and optical measurement, not on a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a machine learning model or a "training set" in the context of AI development, this question is not applicable. The device relies on chemical reactions and optical measurement, for which the underlying scientific principles and performance are validated through the analytical studies described.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.