(77 days)
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
The GEM Premier 3000 is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting that was originally cleared for the U.S. market under K992834, with glucose and lactate parameters added under K010520 and Intelligent Quality Management (iQM) introduced under K022158. The reportable ranges for the Glucose and Lactate parameters are being extended through additional performance testing with the release of a new software version.
The provided text describes an extension of the reportable ranges for Glucose and Lactate parameters on the GEM Premier 3000 device. The study to prove this involved linearity data and detection limit testing.
Here's the information extracted and organized:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for extending the reportable ranges were based on achieving satisfactory linearity as demonstrated by the slope, intercept, and R-squared values from linearity testing. Specific numerical acceptance criteria for these metrics are not explicitly stated as target values, but the reported values indicate the device meets the linearity and detection limit requirements for the extended ranges.
| Parameter | Acceptance Criteria (Implied by study results for extension) | Reported Device Performance (Linearity Data) |
|---|---|---|
| Glucose (mg/dL) | Linear response across the extended range (5 to 500 mg/dL) | Slope: 1.012, Intercept: -1.369, R2: 0.997 |
| Lactate (mmol/L) | Linear response across the extended range (0.2 to 15 mmol/L) | Slope: 1.031, Intercept: -0.028, R2: 0.999 |
Note: The "Acceptance Criteria" column is inferred from the statement that the reportable ranges were extended based on the provided data, implying these performance metrics met the necessary thresholds.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Glucose: 30-32 samples per level
- Lactate: 32-33 samples per level
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be an internal performance evaluation for regulatory submission, likely conducted in a controlled lab setting, which could be considered prospective in nature for new range validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is a performance validation for an in vitro diagnostic device, specifically focusing on linearity and detection limits. Ground truth is established by the known concentrations of calibrators or reference materials used for the linearity testing, not by expert interpretation.
4. Adjudication method for the test set
Not applicable. This type of study does not involve adjudication as it's a technical performance validation against quantitative standards, not qualitative assessments requiring expert consensus.
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 a 510(k) summary for an in vitro diagnostic device measuring blood analytes, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The reported "Performance Data Summary" outlines the linearity of the device's measurements for Glucose and Lactate, which directly reflects the algorithm's (or device's) ability to accurately quantify these parameters across the extended ranges. The study focuses on the device's inherent measurement capabilities.
7. The type of ground truth used
The ground truth for the linearity testing would be the known concentrations of reference materials or calibrators spanning the reportable range. These are precisely prepared solutions with verified analyte concentrations. For Lactate, it's mentioned that samples were "stabilized through repeated washing and icing in vitro for testing," indicating controlled preparation to achieve specific concentrations.
8. The sample size for the training set
Not applicable. This device is not described as utilizing a machine learning algorithm that requires a separate training set. The performance validation is based on direct measurement principles.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
§ 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.