(136 days)
The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) is a semi-automated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™ JET Analyzer and AUTION™ Sticks 10EA test strips are intended for mutually exclusive use as a system.
The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) consists of an analyzer and accessories. ARKRAY also offers a hand-held Bar Code Reader for use with the AUTION™ JET. The AUTION™ JET Analyzer is designed for use only with the AUTIONTM Sticks 10EA multi-parameter test strips.
The provided text doesn't explicitly state quantitative acceptance criteria or a detailed study report with specific performance metrics beyond general statements. However, based on the information given, here's a structured response outlining what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Excellent Agreement (Correlation) | "excellent agreement when results from the AUTION™ JET were compared to those from a commercially available automated urine analyzer." |
| Acceptable Precision | "precision... demonstrated acceptable performance of the AUTION™ JET System for its intended use." |
| Acceptable Linearity | "linearity... demonstrated acceptable performance of the AUTION™ JET System for its intended use." |
| Substantial Equivalence to Predicate Devices | Device found substantially equivalent to predicate devices (Chemstrip 101 Urine Analyzer, AUTION MAX™ AX-4280 Urine Analyzer, Clinitek Atlas Automated Urine Chemistry Analyzer) after performance testing. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin or whether it was retrospective or prospective). It only states that "Several studies were conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication method for the test set
The document does not mention any adjudication method used for the test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The AUTION™ JET AJ-4270 Urine Analyzer is an automated device, not an AI system designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted, as the AUTION™ JET is an automated urine analyzer designed to perform measurements "semi-automated," meaning it processes the test strips and provides results without continuous human interpretation of the actual measurement process.
7. The type of ground truth used
The document implies that the ground truth for the performance studies was established by comparing the AUTION™ JET's results to those of "a commercially available automated urine analyzer," which would serve as a reference or "gold standard" for the correlation study. For precision and linearity, the ground truth would typically be based on known concentrations or repeated measurements from controlled samples.
8. The sample size for the training set
The document does not specify a training set sample size. This device is not described as a machine learning or AI-driven system that would typically undergo a "training" phase in the conventional sense. Its performance is based on established reflectance spectroscopy principles and chemical reactions.
9. How the ground truth for the training set was established
Not applicable for this device as it's not described as an AI/machine learning system with a distinct training phase. Its performance is based on its inherent design, and its accuracy validated against established methods or reference standards.
§ 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.