(81 days)
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring p02, pC02, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance metrics, sample sizes, expert adjudication, or ground truth establishment.
Instead, the document primarily describes a medical device called the "GEM Premier Plus Blood Gas and Electrolyte Analyzer," its intended use, and its technological characteristics compared to a predicate device. It briefly mentions "Clinical Tests to Support Equivalence Determination" but provides very limited detail about these tests.
Therefore, I cannot provide the requested information based on the input text. The information needed for the prompt (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, ground truth type, training set size, and ground truth establishment for training set) is not present in the provided document.
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Section 2 510(k) Summary and Certification
The 2 8 1996
| Contact person : | Andrew C. TaylorDirector of Research and DevelopmentTel : (313) 973 7000Fax : (313) 973 1368 |
|---|---|
| Date : | April 5, 1996 |
| Device Name : | GEM® Premier PlusBlood Gas and Electrolyte Analyzer |
| Predicate Device : | GEM® PremierBlood Gas and Electrolyte Analyzer |
Description :
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring p02, pC02, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
Intended Use :
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Technological Characteristics vs. Predicate Device :
The measurement technology used in the GEM Premier Plus is identical to that used in the predicate device, the GEM Premier
Non Clinical Tests to Support Equivalence Determination
The GEM Premier has been tested and found to comply with UL 544 and IEC1010-1
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Clinical Tests to Support Equivalence Determination
The GEM Premier Plus was tested at five clinical sites and compared to the predicate device, the GEM Premier. All tests were performed by health care professionals with limited training in the use of blood gas and electrolyte analyzers. Patient samples were run on both the GEM Premier Plus and the GEM Premier instruments.
Conclusions Drawn From Clinical Tests
The results from the clinical tests demonstrated that the GEM Premier Plus and the predicate device, the GEM Premier were substantially equivalent in performance.
The manufacturer states that the device is safe and effective for its intended use as a Critical Care Blood Gas and Electrolyte Analyzer when operated per the GEM Premier Plus labeling.
§ 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.