(172 days)
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX analyzer 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. For in vitro diagnostic use.
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX CO-OX analyzer 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. For in vitro diagnostic use.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated systems intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, hematocrit (ABL80 FLEX analyzer only) and the oximetry parameters (ABL80 FLEX CO-OX only) total hemoqlobin, oxygen saturation, FO2Hb, FCOHb, FMetHb, and FHHb.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers consist of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test loads are available. The solution pack is available in four model for each of the four different configurations of the analyzer.
The provided text describes modifications to the ABL80 FLEX and ABL80 FLEX CO-OX analyzers and their substantial equivalence to a predicate device, focusing on glucose measurement. The performance study specifically addresses the glucose pO2 dependence.
Here's an analysis of the acceptance criteria and the study, extracting the requested information:
1. Table of Acceptance Criteria
The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the modifications. However, it presents the defined glucose linearity ranges based on pO2 levels, which can be interpreted as the performance specifications the device meets under different pO2 conditions.
| Parameter | Acceptance Criteria (Defined Linearity Range) | Reported Device Performance (Met Criteria) |
|---|---|---|
| Blood Glucose (cGlu) | 36 – 180 mg/dL (2 – 10 mmol/L) | 36 – 180 mg/dL (2 – 10 mmol/L) |
| when pO2 range is 20 - 40 mmHg | ||
| Blood Glucose (cGlu) | 36 - 270 mg/dL (2 – 15 mmol/L) | 36 - 270 mg/dL (2 – 15 mmol/L) |
| when pO2 range is ≥ 41 mmHg |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size used for the pO2 dependence study. It merely states "A study has been conducted... to characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample."
- Data Provenance: Not explicitly stated. The manufacturer is SenDx Medical Inc, Carlsbad, CA, USA, and Radiometer Medical ApS, Brønshøj, Denmark. This suggests the study could have been conducted in either location or obtained samples from those regions, but no specific country of origin for the data is provided. The study type is prospective as it's a characterization study conducted to determine performance under specific conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a study for an in vitro diagnostic device measuring a chemical analyte (glucose), not an imaging or diagnostic device that requires expert interpretation for ground truth. The ground truth for glucose measurements would typically be established by a reference method/instrument.
4. Adjudication method for the test set
Not applicable, as expert adjudication is not relevant for this type of chemical measurement validation.
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 is not an AI-assisted diagnostic device or an imaging device requiring human reader interpretation. The device is an automated analyzer for chemical measurements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described is a standalone performance evaluation of the ABL80 FLEX and ABL80 FLEX CO-OX analyzers in measuring glucose, specifically demonstrating its performance in relation to pO2 levels. The description of "Automated handling by the software of certain glucose results depending on the pO2 value in the sample" indicates an algorithm-only component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for "glucose linearity" would be established by comparison to a reference method or instrument for glucose measurement, as is standard practice for in vitro diagnostic devices. It does not explicitly state which reference method was used, but it's not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This document describes a performance validation study for a device. It does not refer to a "training set" in the context of machine learning, but rather the validation of instrument performance. If an algorithm was developed through machine learning, its training set details are not provided here.
9. How the ground truth for the training set was established
Not applicable, as a "training set" in the machine learning sense is not described.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.