(131 days)
The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem10 SG Urine Chemistry Strips.
The provided text is a 510(k) summary for the Iris Diagnostics iChem 100 Urine Chemistry Analyzer. It details the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical performance studies. However, it does not provide detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.
Here's an analysis based on the information provided, highlighting what is and is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the provided text. The document states:
- "A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device."
- "Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use."
However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, concordance rates, or quantitative limits for precision and linearity) or their corresponding acceptance criteria are presented in a table format or even as narrative descriptions.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the text. There is no mention of the number of samples used in the "correlation study" or "additional studies for precision and linearity," nor the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. The document refers to "non-clinical studies" and comparisons to a "predicate device." It does not mention the involvement of human experts for establishing ground truth, as would be typical for evaluating diagnostic device performance against a gold standard.
4. Adjudication Method for the Test Set
This information is not provided in the text. Since no experts are mentioned for establishing ground truth, no adjudication method would be detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This is not applicable and not provided. The iChem 100 is described as a "semi-automated benchtop instrument" and an "algorithm only" device for analyzing urine test strips (reflectance spectroscopy). It does not appear to involve human interpretation of images or data that would be augmented by AI, hence an MRMC study with human readers assisting AI is not relevant to this device's evaluation as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The description of the iChem 100 as a "semi-automated benchtop instrument" that "automatically move the test strip to the Optical Block for analysis" and "designed to analyze and generate results" strongly suggests a standalone, algorithm-only performance evaluation. The "correlation study" and "precision and linearity" studies would have evaluated the performance of the instrument itself.
7. The Type of Ground Truth Used
The text indicates that the performance was evaluated by comparing it to a "predicate device" and through "precision and linearity" studies. Therefore, the "ground truth" implicitly relies on:
- Predicate Device Performance: For the correlation study, the results from the ARKRAY AUTION JET "AJ-4270 Urine Analyzer (K030600)" served as the comparator or "ground truth" for establishing substantial equivalence.
- Established Analytical Methods: For precision and linearity, the ground truth would typically be established through controlled samples with known target values, using established analytical methods to determine accuracy and reproducibility.
8. The Sample Size for the Training Set
This information is not provided in the text. The iChem 100 is presented as a medical device for chemical analysis (reflectance spectroscopy), not explicitly as an AI/ML device that requires a distinct "training set" in the common AI sense. While such devices are calibrated and developed using data, the document does not use the terminology of "training set" or specify its size.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the text. As mentioned above, the concept of a "training set" with established ground truth as understood in AI/ML is not explicitly discussed for this device. The development and calibration processes for chemical analyzers typically involve reference materials and established analytical methods.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and general acceptable performance through non-clinical studies (correlation, precision, linearity). However, it lacks the detailed quantitative performance metrics, specific acceptance criteria, sample sizes, and expert ground truth establishment information typically required to fully answer the detailed questions posed about acceptance criteria and study proving its fulfillment.
§ 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.