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The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.

• Sodium measurements are used for monitoring electrolyte imbalances.
• Potassium measurements are used for diagnosis and monitoring of diseases and clinical conditions that manifest high and low Potassium levels.
• Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
• Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
• Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
• Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
• pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
• Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
• The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
• The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
• Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
• The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
• The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
• The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis

The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care. The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability. The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.

This document is a 510(k) summary for the i-STAT 1 Wireless Analyzer, which is a modified version of the i-STAT 1 Analyzer. The submission argues for substantial equivalence primarily based on the fact that the measurement cycle of the device is identical to the predicate device, and the wireless functionality is temporally distinct and does not affect the core measurement performance. As such, the document does not report on a study comparing the diagnostic performance of the i-STAT 1 Wireless Analyzer against specific acceptance criteria for each analyte. Instead, it focuses on the differences and safety aspects related to the addition of wireless communication.

Therefore, much of the requested information cannot be extracted directly from this 510(k) summary because the evaluation approach was not based on a new clinical performance study for the analytes.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This section cannot be fully constructed as a typical acceptance criteria table for diagnostic accuracy because the submission's core argument is that the measurement performance of the i-STAT 1 Wireless Analyzer is identical to the predicate device (i-STAT 1 Analyzer) for all cartridge tests. The only "performance" discussed in relation to the new wireless feature is its safety and data integrity.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for diagnostic accuracy. As noted, no new cartridge tests were performed to compare the diagnostic performance because the measurement cycle is identical to the predicate device. The testing focused on the wireless functionality itself, which does not involve patient samples or diagnostic data in the same way.

The document discusses "Specific Absorption Rate tests conducted by the supplier of the radio frequency module" but does not provide sample sizes or data provenance for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No diagnostic ground truth was established for a new clinical performance test set, as the device's diagnostic measurement capabilities are considered identical to its predicate.

4. Adjudication method for the test set

Not applicable. No new clinical performance test set was conducted that would require adjudication of diagnostic results.

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 an in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly in the context of the device's core function. The i-STAT 1 Wireless Analyzer, like its predicate, is a standalone device that performs quantitative measurements of various analytes. The output (a numerical value for an analyte) does not require human-in-the-loop for its generation. However, the study supporting this submission did not involve a new standalone performance evaluation for the analytes; it relied on the established performance of the predicate device. The wireless functionality itself is an "algorithm only" in terms of data transmission, operating independently of human intervention during the transmission process once configured.

7. The type of ground truth used

Not applicable for a new clinical performance study. The original ground truth for the predicate i-STAT 1 Analyzer's diagnostic measurements would have been established through methods appropriate for each analyte (e.g., comparison to laboratory reference methods, clinical outcomes where relevant). For this 510(k) submission, the ground truth for the wireless transmission involved verifying signal integrity and proper data transfer, but this is an engineering ground truth, not a diagnostic one.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning algorithm that requires a training set in the conventional sense for diagnostic performance.

9. How the ground truth for the training set was established

Not applicable. (See point 8).

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