(246 days)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (p02), Oximetry (s02, ctHb, FCOHb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood.
The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order.
pH and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin plus reduced hemoglobin.
ctHb (Total Hemoglobin): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: Methemoglobin as a fraction of total hemoglobin.
FHHb: Reduced hemoglobin as a fraction of total hemoglobin.
The ABL90 FLEX PLUS System consists of the ABL90 FLEX PLUS analyzer, sensor cassette and solution pack consumables, and related accessories for the analyzers. The sensor cassettes, solution packs and related accessories are compatible with both analyzers. Multiple versions of the sensor cassettes are available. The sensor cassette versions vary in the maximum number of tests and availability of sensors for use. The solution pack is available in two versions, differing in the number of activities available.
The FDA 510(k) summary for the Radiometer ABL90 FLEX PLUS System provides detailed information about the device's analytical performance testing to demonstrate its substantial equivalence to its predicate device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the reported performance metrics (linearity, detection limits, precision, bias) and the comparison to the predicate device. The goal is to show that the ABL90 FLEX PLUS System performs comparably to the predicate (ABL90 FLEX PLUS, K160153) and adheres to recognized standards (CLSI guidelines).
The summary does not explicitly present a table of "acceptance criteria" and "reported performance" side-by-side in a single formatted table. However, the various tables throughout the "Analytical Performance Testing Summary" section serve this purpose by presenting the measured performance of the ABL90 FLEX PLUS System against unstated, but implied, acceptable ranges or a comparison to the predicate.
Here's a synthesized representation of the reported device performance for key analytical parameters, effectively serving as the "reported device performance":
| Parameter | Performance Aspect | Reported Value/Range (ABL90 FLEX PLUS System) | Implied Acceptance Criteria (via comparison to predicate and CLSI guidelines) |
|---|---|---|---|
| pH | Linearity Interval | 6.605-7.997 | Consistent with clinical requirements and predicate's performance. |
| Lower LoQ | 6.754 | Detectable and quantifiable at clinically relevant low levels. | |
| Upper LoQ | 7.843 | Detectable and quantifiable at clinically relevant high levels. | |
| Precision (Repeatability SD) | 0.001-0.003 (blood) | Low variability, suitable for clinical use. | |
| Bias (Method comparison to predicate) | -0.003 | Minimal bias from predicate, within clinical acceptable limits. | |
| pO2 | Linearity Interval | 0.81-75.41 kPa (or mmHg equivalent) | Consistent with clinical requirements and predicate's performance. |
| LoQ | 7.7 mmHg (1.02 kPa) | Detectable and quantifiable at clinically relevant low levels. | |
| Precision (Repeatability SD) | 0.197-1.91 (blood/QC) | Low variability, suitable for clinical use. | |
| Bias (Method comparison to predicate) | -0.454 to 0.344 | Minimal bias from predicate, within clinical acceptable limits. | |
| ctHb | Linearity Interval | 0.068-27.660 g/dL | Consistent with clinical requirements and predicate's performance. |
| LoQ | 0.09 g/dL | Detectable and quantifiable at clinically relevant low levels. | |
| Precision (Repeatability SD) | 0.01-0.091 (blood/QC) | Low variability, suitable for clinical use. | |
| Bias (Method comparison to predicate) | 0.015-0.126 | Minimal bias from predicate, within clinical acceptable limits. | |
| Oximetry (sO2, FO2Hb, FCOHb, FMetHb, FHHb) | Linearity Interval | Ranges provided for each (e.g., sO2: 2.18-100.22%) | Consistent with clinical requirements and predicate's performance. |
| LoQ | Ranges provided for each (e.g., sO2: 1.4%) | Detectable and quantifiable at clinically relevant low levels. | |
| Precision (Repeatability SD) | Low variability reported across all oximetry parameters (blood/QC) | Low variability, suitable for clinical use. | |
| Bias (Method comparison to predicate) | Minimal bias reported across all oximetry parameters | Minimal bias from predicate, within clinical acceptable limits. | |
| Interference | Various interferents (Intralipid, Bilirubin, etc.) | Reported impact on results, indicating levels where interference was not significant or error messages occurred. | Acceptable performance with common interferents, or clear warnings for known interferences. |
Key takeaway for "Acceptance Criteria": The general acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to the predicate device (ABL90 FLEX PLUS, K160153). While explicit numerical acceptance criteria are not presented in this summary document, the testing aims to show that the new device's performance (linearity, detection, precision, bias, interference) is comparable to the predicate and/or meets recognized clinical and analytical standards as outlined in CLSI guidelines.
2. Sample Sizes Used for the Test Set and Data Provenance
- Linearity Testing: Numbers of samples are not explicitly stated for linearity testing, but it was conducted "in general accordance with CLSI EP06... and EP39."
- Detection Capability (LoB, LoD, LoQ): Numbers of samples are not explicitly stated.
- Precision (using stable, aqueous ampoule-based QC material):
- N = 243 or 244 for each QC ampoule level and parameter.
- Data Provenance: Testing occurred at three external sites. The specific countries of origin are not mentioned, but "external sites" suggests a multi-site study. This appears to be a prospective study, as it's part of the premarket submission.
- Precision (using blood):
- N varies by parameter and test interval, ranging from 4 to 188 samples.
- Data Provenance: Not explicitly stated, but implies collected from blood samples (human derived). Likely prospective data collected for the study.
- Method Comparison (Bias):
- N varies by parameter, blood type, and mode (S65/SP65), ranging from 26 to 235 samples (arterial/venous blood).
- Data Provenance: Not explicitly stated, but implies collected from patient blood samples. This would be prospective data collected specifically for the method comparison study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This device (ABL90 FLEX PLUS System) is an in vitro diagnostic (IVD) analytical instrument. The ground truth for its performance is established through reference methods, defined concentrations of analytes in quality control materials, and comparison to a legally marketed predicate device, not typically through human expert adjudication of images or clinical outcomes that require multiple medical professionals.
Therefore, the concept of "experts establishing ground truth" in the way it might apply to an AI imaging device (e.g., radiologists reviewing scans) is not directly applicable here. The "experts" would be the laboratory personnel and analytical chemists who perform the testing and ensure adherence to CLSI guidelines. Their qualifications are implicitly assumed to be appropriate for performing such technical laboratory studies.
4. Adjudication Method for the Test Set
Not applicable for an IVD analytical instrument. Ground truth is established by reference methods, certified materials, and comparison with a predicate device, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are typically performed for imaging devices or diagnostic aids where human interpretation is a key component, often comparing AI-assisted vs. unassisted human performance. This device is an automated, quantitative analytical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (linearity, detection/quantitation, precision, bias, interference) are all measures of the standalone analytical performance of the ABL90 FLEX PLUS System. The device provides quantitative measurements autonomously without continuous human interpretation required for each result.
7. The Type of Ground Truth Used
The ground truth used for this device's analytical performance studies are:
- Reference materials/Certified Analytes: For linearity, detection, and precision testing. These are materials with known, precisely measured concentrations of the analytes (pH, pO2, ctHb, sO2, etc.).
- Predicate Device Measurements: For method comparison/bias studies, the measurements from the legally marketed ABL90 FLEX PLUS (K160153) served as the comparator (or "ground truth" to determine bias relative to the predicate).
- CLSI Guidelines: The studies adhere to relevant Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP06, EP39, EP17-A2, EP05-A3, EP09c, EP07, EP37), which define accepted methodologies and performance characteristics for IVD devices.
8. The Sample Size for the Training Set
Not applicable. This document describes the performance testing for a finished IVD product, not the development or training of a machine learning model. IVD devices like the ABL90 FLEX PLUS System are based on established analytical principles (potentiometry, optical, spectrophotometry) and calibrated using defined reference materials, not "trained" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's analytical principles. Ground truth for calibration and development of such instruments is established through rigorous analytical chemistry methods using highly purified and characterized reference standards.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.