(61 days)
The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use.
Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood.
Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at the factory for each lot of cartridges 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 (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
Here's a breakdown of the acceptance criteria and study information for the Diametrics Medical IRMA® SL Blood Analysis System Lactate Cartridge, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria (Type of Performance) | Acceptance Criteria (Not explicitly stated as criteria, but implied by performance data) | Reported Device Performance (IRMA® SL Lactate Cartridge) |
|---|---|---|
| Accuracy | Comparable to predicate device (YSI Model 2300 Stat Plus) | Slope: 0.97, Intercept: 1.87, r: 0.991, Sy.x: 9.11 |
| Precision | (No explicit numerical criteria given, but implied to be acceptable for clinical use) | Level 1: Mean 7.02 mg/dl, sd 1.08, %CV 15.3 |
| Level 2: Mean 80.11 mg/dl, sd 4.10, %CV 5.1 | ||
| Level 3: Mean 132.8 mg/dl, sd 8.68, %CV 6.5 | ||
| Level 4: Mean 177.5 mg/dl, sd 16.0, %CV 9.0 | ||
| Linearity | (No explicit criteria or detailed results provided in the legible text) | (Insignificant/Illegible text provided) |
Note: The document states "The data demonstrates that the Lactate Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed." This implies that the observed performance meets an unstated acceptance criterion of being comparable to the predicate device.
Study Details
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Sample sizes used for the test set and data provenance:
- Accuracy: n = 30 (Range evaluated 1 - 250 mg/dl).
- Precision: Levels 1, 2, and 3 had n = 59 each. Level 4 had n = 58.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For in vitro diagnostic devices like this, ground truth is typically established by comparative methods using a reference laboratory instrument, not by expert consensus on imaging or clinical interpretation.
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Adjudication method for the test set:
- This information is not applicable/provided for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies).
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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 is an in vitro diagnostic device (IVD) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data (accuracy, precision, linearity) presented are the standalone performance of the IRMA® SL Blood Analysis System Lactate Cartridge itself, as an automated in vitro diagnostic device without human interpretation as part of the core measurement process. Human interaction is limited to sample collection, cartridge insertion, and reading the displayed results.
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The type of ground truth used:
- For accuracy, the ground truth would have been established by comparing the device's results against a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, which is mentioned as the predicate). The "Slope," "Intercept," and "r" values indicate a regression analysis comparing the new device to a reference.
- For precision, the ground truth is statistical, derived from repeated measurements of the same sample, indicating reproducibility.
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The sample size for the training set:
- Not applicable/provided. This device is a sensor-based system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "factory derived calibration parameters" mentioned in the device description contribute to its operational accuracy, but this is a manufacturing/calibration process, not an AI training process.
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How the ground truth for the training set was established:
- Not applicable/provided for the reason stated in point 7. The calibration of the cartridge uses "information determined at the factory for each lot of cartridges" and "measurements taken during the calibration process." This involves pre-determined factory parameters and on-site calibration measurements, not a ground truth established for a "training set" in an AI context.
§ 862.1450 Lactic acid test system.
(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(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.