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The RAPIDPoint® 500e Blood Gas System is in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

• Partial pressure of carbon dioxide ●
• Partial pressure of oxygen
• pH
• Sodium ●
• Potassium
• lonized Calcium ●
• Chloride .
• Glucose ●
• . Lactate
• . Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb
• . Neonatal Bilirubin

The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for the pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

The following critical value applies to pleural fluid pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement

The RAPIDPoint 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and is suitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases, electrolytes, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.

The RAPIDPoint 500e Blood Gas System incorporates a cartridge-based design with no external reagent bottles or gas tanks. The system uses self-contained measurement and wash/waste cartridges that are replaced when depleted. The system automatically calibrates the measurement sensors and reports results within 60 seconds for display on a color touch screen for easy viewing.

The provided text concerns the FDA 510(k) summary for the RAPIDPoint® 500e Blood Gas System. This document describes a modification to an existing device (RAPIDPoint 500 System) and asserts its substantial equivalence for FDA clearance. Therefore, a study to prove the device meets specific acceptance criteria for a new clinical claim (such as disease diagnosis accuracy based on images) is not applicable here.

The submission is a Special 510(k), meaning the changes are minor and do not alter the intended use, fundamental scientific technology, labeling, or principle of operation. The primary changes are an operating system update and minor hardware/software enhancements.

Key points from the document regarding "acceptance criteria" and "study:

• No new performance claims: The document explicitly states: "There is no change to labeled performance claims." This implies that the performance criteria previously established for the predicate device (RAPIDPoint 500 System) are still considered valid and met by the modified device.
• Verification and validation activities: The document states: "All verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Siemens Design Control procedures. Testing verified all acceptance criteria were met." This refers to internal engineering and design control testing to ensure the modifications haven't negatively impacted the known performance characteristics of the device.

Given this context, I cannot generate a table of acceptance criteria and reported device performance in the typical sense of a clinical diagnostic study with new performance endpoints. The "acceptance criteria" here refers to demonstrating that the modified device performs comparably to the predicate for all existing measurements and that the new software/hardware features function as intended without compromising safety or effectiveness.

Therefore, the requested information elements cannot be fully addressed in the way they would for a device making new diagnostic claims based on a primary clinical study.

Here's an attempt to answer the questions based on the available information, noting where specific details are not provided:

1. A table of acceptance criteria and the reported device performance

   As this is a Special 510(k) for a modified device with "no change to labeled performance claims" and "no change to principle of operation," there isn't a new set of clinical performance acceptance criteria and reported performance figures presented in this summary document. The acceptance criteria implicitly refer to demonstrating that the modified device's performance is substantially equivalent to the predicate device across all analytes and clinical uses, meaning it continues to meet the predicate's established performance specifications. The document states: "Performance testing results were also comparable."

   Inferred Acceptance Criteria (based on substantial equivalence to predicate):
   The modified device (RAPIDPoint 500e Blood Gas System) must demonstrate performance comparable to the legally marketed predicate device (RAPIDPoint 500 System) for all measured analytes (pCO2, pO2, pH, Sodium, Potassium, Ionized Calcium, Chloride, Glucose, Lactate, Total Hemoglobin and fractions, Neonatal Bilirubin) in whole blood and pH in pleural fluid. This comparability would typically be assessed by demonstrating agreement (e.g., bias, precision, linearity) within acceptable limits as defined for the predicate device.

   Reported Device Performance:
   The document states: "Performance testing results were also comparable." Specific numerical performance data (e.g., accuracy, precision) for each analyte for the modified device are not provided in this 510(k) summary, as the submission focuses on substantial equivalence of the modified device to the predicate, rather than establishing new performance specifications.

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

   Not explicitly stated in the provided document. The document refers to "verification and validation activities" and "performance testing results," but does not detail the sample sizes or the provenance (e.g., country of origin, retrospective/prospective) of the data used for establishing "comparable" performance. Given it's a diagnostic device for blood analysis, samples would typically be human blood and pleural fluid.

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

   Not applicable or not specified. For laboratory diagnostic devices like blood gas analyzers, "ground truth" is typically established by reference methods or highly accurate laboratory instruments, not by a panel of human experts interpreting data.

4. Adjudication method for the test set

   Not applicable or not specified. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for endpoint determination (e.g., presence of disease from images) based on multiple expert opinions. For a blood gas system, the performance is evaluated by comparing measurements against reference methods, not subjective adjudication.

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 (IVD) blood gas system, not an AI-assisted diagnostic imaging or interpretation device that involves human "readers."

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

   This device is an automated in vitro diagnostic system. Its "standalone" performance means the accuracy and reliability of its measurements of various blood parameters. While the document mentions software changes and cybersecurity enhancements, it is not an algorithm that interprets human-generated data or makes a diagnosis. Its performance is inherent to its measurement capabilities. The 510(k) summary asserts that its performance is "substantially equivalent" to the predicate, implying successful internal testing to confirm this.

7. The type of ground truth used

   For IVD devices measuring physiological parameters, "ground truth" is typically established by:

   • Reference methods: Highly accurate and validated analytical methods (e.g., gas chromatography for blood gases, gravimetric methods for electrolytes) or
   • Comparison to predicate/established devices: Comparing measurements from the device under evaluation to a legally marketed and well-characterized predicate device or other established clinical laboratory instruments.

   This document explicitly states the modified device is "substantially equivalent to the comparative method" (referring to the predicate device).

8. The sample size for the training set

   Not applicable or not specified. This is a measurement device for chemical and physiological parameters, not a machine learning model that requires a distinct "training set" of clinical data in the typical sense. Any internal developmental data would be for engineering optimization rather than model training.

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

   Not applicable (as it's not an AI/ML device requiring a training set in that context).

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