(121 days)
The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.
The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro quantities of micro albumin in in human urine samples on Beckman's IMMAGE™ Immunochemistry System.
Here's an analysis of the provided text regarding the Beckman IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, structured according to your request:
In this case, the "device" is the IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent, an in-vitro diagnostic test. The acceptance criteria for such devices typically revolve around analytical performance metrics that demonstrate its ability to accurately and reliably measure the intended analyte compared to a predicate device.
Acceptance Criteria and Reported Device Performance for IMMAGE™ Immunochemistry System Microalbumin (MA) Reagent
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. However, based on the studies performed, the implicit acceptance criteria are that the IMMAGE MA Reagent demonstrates:
- Substantial Equivalence: Performance comparable to the predicate device (Beckman MA Microalbumin Reagent Kit).
- Analytical Performance: Acceptable linearity (demonstrated by method comparison), precision (imprecision study), and stability (shelf-life and open container stability).
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate (Beckman MA Reagent Kit), indicated by high correlation (r), slope close to 1, and intercept close to 0. | Slope: 0.957 |
| Intercept: -0.03 | ||
| Correlation (r): 0.991 | ||
| (Compared against Beckman MA Reagent on Array® 360 System) | ||
| Total Imprecision | Acceptable variability at different analyte levels. | Level 1 (0.56 mg/dL): S.D. 0.055 mg/dL, %C.V. 9.8% |
| Level 2 (2.25 mg/dL): S.D. 0.121 mg/dL, %C.V. 5.4% | ||
| Level 3 (3.19 mg/dL): S.D. 0.073 mg/dL, %C.V. 2.3% | ||
| Within-Run Imprecision | Acceptable variability within a single run. | Level 1 (0.56 mg/dL): S.D. 0.042 mg/dL, %C.V. 7.5% |
| Level 2 (2.25 mg/dL): S.D. 0.107 mg/dL, %C.V. 4.7% | ||
| Level 3 (3.19 mg/dL): S.D. 0.063 mg/dL, %C.V. 2.0% | ||
| Shelf-life Stability | Functional and accurate for a specified period. | 6 month shelf-life |
| Open Container Stability | Functional and accurate for a specified period after opening. | 14 day open container stability |
| Calibration Stability | Calibration remains valid for a specified period. | 7 day calibration stability |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison:
- Sample Size: n = 109 urine samples.
- Data Provenance: Not explicitly stated, but clinical samples are implied as "urine samples." The country of origin and whether they were retrospective or prospective is not specified in this summary.
- Imprecision Study:
- Sample Size: n = 80 measurements for each of the three levels (total 240 measurements for each imprecision type). These are likely replicates of control or spiked samples, not individual patient samples.
- Data Provenance: Not specified, but standard laboratory controls or prepared samples would be used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of in-vitro diagnostic device. The "ground truth" for analytical performance studies is established by a reference method (the predicate device in this case) or by careful preparation of known concentration standards. Expert interpretation of results is not typically the primary ground truth for an analytical performance claim.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for subjective interpretations (e.g., imaging studies) where multiple human readers are involved. For quantitative analytical tests like this, the 'ground truth' is a numerical value from a reference method or known standard, not a consensus interpretation.
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
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, not an AI-powered image analysis tool or decision support system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (method comparison, stability, imprecision) demonstrate the standalone performance of the IMMAGE MA Reagent on the IMMAGE Immunochemistry System. This is an "algorithm only" type of test in the sense that the instrument's measurement algorithm processes the chemical reaction data to produce a quantitative result without direct human interpretation of the measurement itself (beyond operating the instrument and interpreting the final numerical value).
7. The Type of Ground Truth Used
- For Method Comparison: The ground truth was established by comparing the IMMAGE MA Reagent to the Beckman MA Reagent on the Array® 360 System (the predicate method). This is a reference method comparison.
- For Imprecision Studies: The ground truth for the mean values was established by known concentrations of control or spiked samples (Level 1, Level 2, Level 3).
8. The Sample Size for the Training Set
Not explicitly stated or applicable in the traditional sense of machine learning. This is an analytical chemistry reagent, not a machine learning algorithm that requires a "training set" of data to learn patterns. The "training" for such a system would involve validating its chemical components and instrument parameters during development, but this is not typically referred to as a "training set" in regulatory submissions for these types of devices. If any 'training' data was used, it would be for internal development and optimization of the reagent and instrument parameters, not disclosed as a specific "training set" in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" with established ground truth in the context of machine learning does not directly apply here. For the development and optimization of the reagent and instrument, the ground truth would have been established through:
- Known concentrations: Prepared solutions of microalbumin at precise concentrations.
- Reference materials: Certified reference materials for albumin.
- Historical data: Performance relative to established analytical methods during development.
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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.