(65 days)
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.
As part of this program, GEM CVP 1 and 2 (Calibration Valuation Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2 pO2, Na . K , CI , Ca * , glucose, lactate, hematocrit and CO-Oximetry (tHb, O2Hb, MetHb, HHb) parameters. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iOM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls.
As part of this program, GEM CVP 1 and 2 (Calibration Product) with CO-Ox and GEM CVP 3 and 4 Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration after initial warm-up. The reported values for the four levels of GEM CVP (two levels for pH, blood gases, electrolytes, metabolites and CO-Oximetry; two levels for hematocrit) must meet specifications before the iQM cartidge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
The provided text focuses on the 510(k) summary for the GEM Premier 4000 with iQM and GEM CVP. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the way you've requested (e.g., specific sensitivity/specificity values, error rates, or statistical comparisons of performance benchmarks).
The document primarily states:
- "In-house and field site testing supports that the GEM Premier 4000 with iOM in conjunction with GEM CVP 1 and 2 with CO-Ox and GEM CVP 3 and 4 Hematocrit is not materially different from the above listed predicate devices in performance, safety and effectiveness or intended use."
This indicates that studies were performed to demonstrate substantial equivalence, but the details of those studies, including acceptance criteria and results, are not provided in this 510(k) summary. These details would typically be found in the full 510(k) submission, which is not publicly accessible in its entirety.
Therefore, I cannot populate the table or answer most of your specific questions based on the information provided. I can only report what is explicitly stated in the document.
Here's what can be extracted based on the provided text, and where information is missing:
Acceptance Criteria and Device Performance
The document does not provide a table of explicit acceptance criteria or reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each analyte. It broadly states that the device is "not materially different" in performance from predicate devices, which is the basis for 510(k) clearance.
| Analyte/Parameter | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| pH | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| pCO2 | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| pO2 | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Na+ | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| K+ | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Cl- | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Ca++ | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Glucose | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Lactate | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| Hematocrit | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| tHb (CO-Oximetry) | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| O2Hb (CO-Oximetry) | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| MetHb (CO-Oximetry) | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
| HHb (CO-Oximetry) | N/A (implied comparable to predicate) | N/A (implied comparable to predicate) |
Study Information (Based on available text):
- Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "In-house and field site testing" but does not give sample sizes, country of origin, or whether data was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
- 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 an automated in vitro diagnostic analyzer, not an AI-assisted imaging or diagnostic tool for human readers. It measures biochemical parameters directly.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device (GEM Premier 4000) itself performs the analysis automatically. The iQM system is described as "an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls." This implies standalone operation in terms of analytical performance. The external CVP solutions are for calibration verification.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for in vitro diagnostic devices measuring analytes, ground truth is typically established by reference methods or validated laboratory methods.
- The sample size for the training set: Not applicable/specified. This is an analytical device, not a machine learning model that typically has a distinct "training set" in the sense of AI/ML. The internal iQM system learns/monitors from its ongoing operations and calibrations rather than a separate training set.
- How the ground truth for the training set was established: Not applicable/specified (see point 7).
§ 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.