(173 days)
Intended Use: The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Indications for Use: The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.
The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
The provided document describes the IRMA® SL Blood Analysis System CR Creatinine Cartridge, a device for in vitro measurement of creatinine in whole blood. The study presented focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in a typical AI/ML medical device submission format.
However, based on the performance data provided, we can infer some "acceptance criteria" through comparison with the reported device performance, particularly in the context of demonstrating substantial equivalence to a predicate device.
Here's an attempt to structure the information according to your request, with a strong caveat that this is an interpretation of the provided regulatory submission format.
Acceptance Criteria and Study Details for the IRMA® SL Blood Analysis System CR Creatinine Cartridge
The provided document, a 510(k) summary, demonstrates the substantial equivalence of the IRMA® SL Blood Analysis System CR Creatinine Cartridge to a predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides). The acceptance criteria are implicitly derived from the performance deemed acceptable for equivalence in the context of an in vitro diagnostic device, specifically regarding accuracy, precision, and linearity.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not stated as pass/fail thresholds but rather performance characteristics for substantial equivalence, the "acceptance criteria" are represented by the demonstrated performance itself, showing it is comparable to or better than the predicate device and within clinically acceptable ranges.
| Performance Metric | Implied Acceptance Criteria (via predicate comparison/clinical expectation) | Reported Device Performance (IRMA® CR Creatinine Cartridge) |
|---|---|---|
| Accuracy (vs. Predicate) | High correlation (R value close to 1), low bias (slope close to 1, intercept close to 0). | Slope: 0.94 |
| Intercept: 0.16 | ||
| R (correlation coefficient): 0.98 | ||
| Sy.x (Standard Error of the Estimate): 0.55 | ||
| Precision (Total Precision %CV) | Acceptable variability across clinically relevant concentrations. Lower %CV indicates better precision. | Level 1 (0.67 mg/dl): 12.6% |
| Level 2 (1.93 mg/dl): 3.8% | ||
| Level 3 (4.41 mg/dl): 9.1% | ||
| Level 4 (10.17 mg/dl): 6.9% | ||
| Level 5 (17.80 mg/dl): 7.7% | ||
| Level 6 (22.68 mg/dl): 7.3% | ||
| Linearity | Device measurements should be linear across its claimed measuring range. | Assessment: Linear across 0.2 – 20.0 mg/dl |
| Measuring Range | Must cover clinically relevant creatinine concentrations. | 0.2 - 20.0 mg/dL (17.7 - 1768.5 mmol/L) |
| Minimum Detection Limit | Sufficiently low to detect clinically relevant low creatinine levels. | 0.04 mg/dl (3.5 mmol/L) |
2. Sample Size Used for the Test Set and Data Provenance:
- Accuracy Test Set (Correlation Study): The number of samples for the accuracy study is ambiguously reported as
1. However, the range evaluated was 0.5 - 10.1 mg/dl, suggesting multiple samples were indeed used to calculate the slope, intercept, and correlation coefficient. The exact number of individual patient samples in the test set is not explicitly stated in the provided text. - Precision Test Set: The number of replicates (N) for each level ranged from 12 to 60.
- Level 1: N=12
- Level 2: N=56
- Level 3: N=54
- Level 4: N=58
- Level 5: N=60
- Level 6: N=52
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it's typically prospective clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This device is an in vitro diagnostic (IVD) based on enzymatic methods, not an AI/ML device relying on expert image interpretation. Therefore, "experts" in the context of establishing ground truth (e.g., radiologists, pathologists) are not applicable in the same way. The ground truth (reference values) would have been established by the predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides) and/or other established laboratory methods, which are inherently "expert" systems in the sense of being widely accepted and validated.
4. Adjudication Method for the Test Set:
- Not applicable as this is a biochemical measurement comparison, not a diagnostic interpretation from human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this is not an MRMC study. It is a comparison of an IVD device's performance to a predicate IVD device. The concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The performance data presented is standalone performance, as it represents the analytical performance of the IRMA® SL Blood Analysis System CR Creatinine Cartridge itself (accuracy, precision, linearity). Although it's an IVD test and operators are involved in sample handling, the "algorithm" (enzymatic method) performance is evaluated directly.
7. The Type of Ground Truth Used:
- Accuracy Study: The ground truth for the accuracy study was established by comparing the IRMA® device's results to those of the predicate device, the Vitros DT60 II Chemistry System / Vitros CRSC DT Slides.
- Precision and Linearity Studies: Ground truth (reference values) would be established using known control materials or dilutions of samples with known concentrations, or by reference methods, though specific details are not provided.
8. The Sample Size for the Training Set:
- Not applicable in the context of this device and study. This device uses an enzymatic chemical method, not a machine learning algorithm that requires a "training set" in the conventional sense. The "calibration" process mentioned (combining factory-determined information with measurements during calibration) serves a similar function to training in some ways, but it's not a data-driven training set like in AI/ML.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as there is no "training set" in the AI/ML context. Calibration for the cartridge is described as combining "information determined at the factory for each lot of cartridges" with "measurements taken during the calibration process" using a calibrant packaged with the sensor. This factory information and calibrant effectively establish the "ground truth" for the device's internal calibration.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.