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The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.

The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.

The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.

The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Precision (Plasma): Sample details (number of unique patient samples) are not explicitly stated, but the study used "Control 1, Control 2, Plasma Pool 1, Plasma Pool 2," indicating pooled or control materials. Tested over five days.
• Precision (Whole Blood): Four (4) fresh, lithium heparin whole blood samples. Each sample was replicated 16 times (N=16 for each sample type).
• Linearity: Whole blood, serum, and plasma samples of varying analyte levels that spanned the reportable range of the tests. Specific number of samples not given, but refers to "various concentration ranges tested."
• Limit of Quantitation (LoQ): Not specified beyond "four low level samples."
• Method Comparison:
  • Site 1: 178 samples for Whole Blood, 178 for Plasma, and 178 for Serum.
  • Site 2: 130 samples for Whole Blood.
  • Provenance: Not explicitly stated, but the mention of "CLIA waived site" and "Moderately Complex Site" suggests the studies were conducted in the United States. The data appears to be prospective as it involves active testing of samples using the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic interpretation. This is an in vitro diagnostic device that quantifies potassium levels.
• For the analytical performance studies (Precision, Linearity, LoQ, Method Comparison), the "ground truth" or reference values are established by the comparative method device (Siemens VISTA ISE) and controlled materials with known concentrations. The studies were run by operators at different sites, including a CLIA waived site, indicating standard laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This concept is not applicable to the evaluation of this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where multiple readers interpret images, and discrepancies need to be resolved. For a potassium test, the output is a quantitative value, not subject to subjective interpretation requiring 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers and AI assistance. This device is a quantitative assay, not an imaging or interpretative AI system.

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

• Yes, the performance studies (Precision, Linearity, LoQ, Method Comparison) represent the standalone performance of the device (Piccolo® Potassium Test System on the Piccolo Xpress® chemistry analyzer). While human operators physically load samples and start the tests, the analysis and quantification are performed by the device's integrated system (chemistry analyzer and reagent disc) without human interpretation steps that could be influenced by the device's output. The results presented are the direct output of the device compared against reference methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The ground truth for the analytical performance studies was established using:
  • Comparative Method Device: Siemens Dimension Vista® Integrated System (Potassium ISE Test, K051087) as the reference method for the method comparison studies.
  • Controlled Materials: For precision, control materials and plasma pools with known or expected potassium concentrations were used.
  • Prepared Samples: For linearity, samples were prepared to span the reportable range. For LoQ, native blood samples were diluted to target concentrations.

8. The sample size for the training set:

• This device is an in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device would involve its chemical design, optical system calibration, and reagent formulation derived from extensive R&D, rather than a data-driven training set used for AI model development. Therefore, a specific "training set sample size" as typically understood for AI models is not applicable.

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

• As mentioned above, the concept of a "training set" and its "ground truth" for this type of in vitro diagnostic device (a chemical assay) is not directly analogous to AI/machine learning. The device's operational parameters and accuracy are established through its engineering design, chemical principles, and extensive internal validation and calibration processes during development and manufacturing. The comparisons to predicate devices and reference methods serve to validate its performance post-development.

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For in vitro quantitative determination of potassium in human serum. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For IVD use only.

Calibrator:

The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ113C). For IVD use only.

Controls:

The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ113C). For IVD use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Diazyme Liquid Stable Enzymatic Potassium Assay Kit". This document primarily focuses on the regulatory approval process and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance.

Therefore, I cannot provide the requested information. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or human reader improvement with AI.
6. Details on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report. To find the information you're looking for, you would typically need to consult a detailed clinical validation report or a scientific publication related to this specific device.

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Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in serum. Results obtained by this assay are used to monitor fluid and electrolyte balance.

Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

Not Found

The provided text is a 510(k) clearance letter for the Diazyme Potassium Enzymatic Assay Kit. It primarily focuses on the regulatory approval process and states the device's intended use. It does not contain specific information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or their data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the input text. This document is a regulatory approval notice, not a scientific study report detailing performance metrics and study design.

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Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative determination of Potassium (K) in serum.

Potassium is determined spectrophotometrically through a kinetic coupling assay system using potassium dependent urea amidolyase (UAL). NADH generated in a coupling enzymatic reaction reduces a water soluble colorless tetrazolium salt, WST-1 in the presence of an electron mediator, 1-methoxy-5-methyl-phenazinium methyl sulfate (PMS), to form a water soluble formazan dye, which has a maximum absorbance at 450 nm. The corresponding increase of optical density at 450 nm is proportional to the potassium concentration in the serum. Diazyme's Potassium Enzymatic Assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 15 min by measuring absorbance at 450 nm. No off line pretreatment is needed. The assay has a wide measuring range from 2 to 8 mmol/L of serum potassium.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) submission, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison with the predicate device and the general understanding of what constitutes a "good correlation," "excellent precision," and "little interference" for an in vitro diagnostic device of this type. Specific numerical targets for correlation or precision are not explicitly stated as "acceptance criteria" but are demonstrated through the study results.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: The document mentions "clinical patient serum samples" were used for comparison analysis but does not specify the exact number of samples in the test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. It implies retrospective data as it refers to comparing results with a legally marketed predicate device on patient samples, but does not explicitly state if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For in vitro diagnostic assays measuring an analyte like potassium, the "ground truth" is typically established by the results from a recognized reference method or a legally marketed predicate device, as opposed to expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As explained in point 3, the "ground truth" for this type of device is an objective measurement rather than a subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted and is not applicable for this type of in vitro diagnostic device. This study design is typically used for imaging or diagnostic devices where human readers interpret results, and the AI assists in that interpretation. This device is an automated enzymatic assay.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document describes several performance characteristics of the Diazyme Potassium Enzymatic Assay itself, including:

• Precision: Stated as "excellent precision" with a table (though unreadable).
• Measuring Range: 2 to 8 mmol/L.
• Analytical Recovery: Demonstrated with spiked samples.
• Interference Study: Tested against various common substances.
• Correlation: Compared to the predicate Synchron LX I 725 Clinical System using clinical patient serum samples.

This comprehensive characterization of the Diazyme device's performance, independently and in comparison to a predicate, constitutes a standalone performance study.

7. Type of Ground Truth Used

The ground truth for the test set (clinical patient serum samples) was established by comparison with a legally marketed predicate device (Synchron LX I 725 Clinical System), which itself would have been validated against established reference methods or clinical outcomes. The document also refers to a "comparison analysis" with the predicate, indicating the predicate's results served as the reference for evaluating the new device's accuracy.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This is typical for an enzymatic assay, where the assay reagents and parameters are developed and optimized through laboratory work and internal validation rather than machine learning on a distinct training dataset.

9. How the Ground Truth for the Training Set Was Established

Since no distinct "training set" for an algorithm is mentioned or implied, the concept of establishing ground truth for a training set is not applicable. The "ground truth" in the development of such assays refers to the accurate measurement of potassium in known samples (e.g., calibrators, controls, or reference materials) that are used to develop and optimize the assay's chemical and enzymatic reactions and calibration curves.

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