(197 days)
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays for clinical use in physician office laboratories or clinical laboratories.
The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance
- Potassium measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry System. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
In the ACE Glucose Reagent assay, glucose in serum reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.
The ACE Ion Selective Electrode (ISE) Module is used with ACE CAL A and CAL B Calibration Solutions in the performance of a two-point calibration in order to measure concentrations of sodium, potassium and chloride in undiluted serum. The ISE module uses a potentiometric method to simultaneously measure sodium, potassium and chloride in undiluted serum. Each electrode uses an ion-specific membrane to measure the difference in ionic concentration between an inner electrolyte solution and the sample. This difference causes an electro-chemical potential to form on the membrane of the active electrode. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. The two-point calibration with CAL A and CAL B with precisely known ion concentrations (two-point calibration) and the measured voltage difference of the sample and CAL A are used to determine the ion concentration in the sample.
Here's a summary of the acceptance criteria and study information for the Alfa Wassermann ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, and ACE Glucose Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Accuracy" data, where the device (y) is compared to a predicate device (x). The close correlation, with slopes near 1 and intercepts near 0, along with high correlation coefficients, indicates acceptable accuracy. Precision is evaluated by the Coefficient of Variation (CV%).
| Measurement (Reagent/Module) | Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (ACE Axcel Clinical Chemistry System) |
|---|---|---|---|
| ACE Glucose Reagent | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.4% (lab setting, 4 levels, 22 days); 0.3 to 2.2% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.9% (lab setting); 0.5 to 2.2% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9998 (lab setting, 122 samples); 0.9992 to 0.9998 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 1.001 to 1.009 (lab setting); 0.972 to 1.021 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.5 to 0.1 (lab setting); -3.0 to 4.1 (POL sites) | |
| Detection Limit | (Not explicitly stated, but low is desirable) | 3.1 mg/dL | |
| ACE Axcel Sodium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.4 to 1.0% (lab setting, 4 levels, 21 days); 0.6 to 1.0% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 0.8 to 1.4% (lab setting); 0.8 to 1.4% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9963 (lab setting, 113 samples); 0.9917 to 0.9995 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.992 to 1.024 (lab setting); 0.989 to 1.067 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -3.60 to 0.92 (lab setting); -8.85 to 2.30 (POL sites) | |
| ACE Axcel Potassium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.6 to 3.5% (lab setting, 4 levels, 21 days); 1.0 to 1.6% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.3 to 3.5% (lab setting); 1.1 to 1.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9974 (lab setting, 115 samples); 0.9973 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.989 to 1.015 (lab setting); 0.960 to 1.035 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -0.050 to 0.095 (lab setting); -0.194 to 0.216 (POL sites) | |
| ACE Axcel Chloride ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.5 to 1.0% (lab setting, 4 levels, 21 days); 0.9 to 1.5% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.1 to 1.5% (lab setting); 1.1 to 2.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9855 (lab setting, 111 samples); 0.9885 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.939 to 1.002 (lab setting); 0.976 to 1.088 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.07 to 5.63 (lab setting); -8.16 to 2.22 (POL sites) |
2. Sample Size Used for the Test Set and Data Provenance
-
ACE Glucose Reagent:
- Accuracy (Correlation Study): 122 samples (ranging from 6 to 729 mg/dL).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites. Specific sample numbers per POL site are not provided, but the combined sites yielded multiple correlation coefficients, standard error estimates, and confidence intervals for slope and intercept.
- Provenance: Not explicitly stated, but likely from a laboratory setting and Physician Office Laboratories, presumably within the US given the submission to the FDA. The nature of the samples (e.g., patient samples, control materials) is not specified as prospective or retrospective.
-
ACE Axcel Sodium ISE:
- Accuracy (Correlation Study): 113 samples (ranging from 45.1 to 194.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
-
ACE Axcel Potassium ISE:
- Accuracy (Correlation Study): 115 samples (ranging from 1.57 to 14.20 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
-
ACE Axcel Chloride ISE:
- Accuracy (Correlation Study): 111 samples (ranging from 63.4 to 176.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
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, "ground truth" is established by comparing the performance of the new device to a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents) using quantitative measurements, not by expert interpretation. The predicate device itself acts as the reference method in these correlation studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative comparison against a predicate device, not an interpretation-based ground truth requiring adjudication.
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
Not applicable. This device is a clinical chemistry analyzer, an automated system for measuring analytes in samples. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are inherently "standalone" in the sense that they evaluate the performance of the ACE Axcel Clinical Chemistry System (including its reagents and ISE module) in producing quantitative results independently. The accuracy studies compare its output directly against a predicate device's output. There isn't a "human-in-the-loop" aspect to the core measurement performance itself.
7. The Type of Ground Truth Used
The "ground truth" for the accuracy studies is the quantitative result obtained from the predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents). The studies are correlation studies comparing the new device's measurements (y) to the predicate device's measurements (x).
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (clinical chemistry analyzer), not a machine learning or AI-based device that typically has a "training set." The device is intended to perform measurements based on established chemical and electrochemical principles.
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 development as described in the provided text.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.