(65 days)
The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG), turbidity, and color. The AUTION MAX is intended for use only with the AUTION Sticks 9EB multi-parameter test strips.
The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers an external printer and hand-held Bar Code Reader for use with the AUTION MAX. The sample-handling capacity of the AUTION MAX can be expanded through the use of the Extensional Sampler. The AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multiparameter test strips.
The proposed AUTION MAX Analyzer contains:
- Mechanical systems for handling the test strips, urine specimens, wash solution, and system waste
- Measurement units for reading the test strips and analyzing the physical properties of the urine
- Software control system for automation of Analyzer and Sampler operation, processing commands and information input by the user, displaying system and specimen information, and monitoring system functions
- RS-232C interface for exporting measurement results and urine specimen identification information
The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification.
The proposed AUTION MAX Analyzer uses reflectance spectroscopy for the measurement of the urine analytes GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and urine color. Urine SG is determined using the refractive index method, and turbidity is evaluated by measuring the transmission and scattering of light passing through the urine specimen.
Here's an analysis of the acceptance criteria and study information provided for the AUTION MAX™ AX-4280 Urinalysis System:
Acceptance Criteria and Device Performance Study for AUTION MAX™ AX-4280 Urinalysis System
The provided documentation states that "Several studies were conducted to evaluate the performance characteristics of the AUTION MAX Urinalysis System. A correlation study demonstrated excellent agreement when results from the AUTION MAX were compared to those from a commercially available automated urine analyzer. Additional studies for precision, carryover, and linearity demonstrated acceptable performance of the AUTION MAX System for its intended use."
However, specific acceptance criteria values (e.g., specific thresholds for correlation coefficients, precision limits, carryover percentages, or linearity ranges) are not explicitly detailed in the provided text. Similarly, the reported numerical device performance against these non-specified criteria is also not given. The statement merely indicates "excellent agreement" and "acceptable performance."
Therefore, the table below reflects what can be inferred from the provided text, acknowledging the lack of quantitative detail.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Correlation | Excellent agreement with a commercially available automated urine analyzer. | Demonstrated excellent agreement with a commercially available automated urine analyzer (e.g., Clinitek Atlas or Chemstrip Super UA). |
| Precision | Acceptable performance for intended use. | Demonstrated acceptable performance. |
| Carryover | Acceptable performance for intended use. | Demonstrated acceptable performance. |
| Linearity | Acceptable performance for intended use. | Demonstrated acceptable performance. |
Additional Study Information:
Due to the limited detail in the provided 510(k) summary, specific answers for many of the requested categories are not available.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study primarily focused on comparison with another automated analyzer rather than expert-established ground truth for individual analytes in this context.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the comparative nature with existing automated devices, a traditional expert adjudication method for ground truth might not have been the primary method for this type of performance testing in this context.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is an automated urinalysis system, not an AI-assisted diagnostic tool for human readers. Its purpose is to perform the analysis independently.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance testing described (correlation, precision, carryover, linearity) evaluates the AUTION MAX™ AX-4280 Urinalysis System as a standalone automated device without direct human-in-the-loop performance influencing the measurement of the analytes. The system is designed to provide automated results.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "correlation study," the "ground truth" was established by the results from a commercially available automated urine analyzer (specifically a predicate device like the Clinitek Atlas or Chemstrip Super UA). For precision, carryover, and linearity studies, the ground truth would be based on known concentrations or control materials as per standard laboratory validation protocols, though not explicitly stated as "ground truth."
-
The sample size for the training set:
- Not applicable/Not specified. This is a medical device, not a machine learning model that undergoes a distinct "training" phase with a specific training set in the context of typical AI model development. The system's "training" would be its inherent design, calibration, and manufacturing process.
-
How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons stated above. Its performance is validated against predicate devices and standard analytical measurements.
§ 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.