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510(k) Data Aggregation
(567 days)
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:
| Performance Characteristic | Acceptance Criteria (Implied by CLIA goals or standard practices) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within Run %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 2.79% | |
| - Control 2 (6.19 mmol/L) | 1.38% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.31% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.58% | |
| Total %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 3.28% | |
| - Control 2 (6.19 mmol/L) | 1.65% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.89% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.89% | |
| Total %CV (Whole Blood, range 3.9-4.0 mmol/L) | Lower is better | 2.8% - 3.9% |
| Linearity | Deviation from linearity (DL) within ±0.5 mmol/L (per 42 CFR 493.931) | For all three matrices and various concentration ranges tested, the DL estimate was within +/- 0.31. R-square estimates were all > 0.98. RMSE estimates <= 0.32. |
| Limit of Quantitation (LoQ) | Not explicitly stated, but generally, the lowest concentration at which the device can reproducibly measure. | Determined to be 1.5 mmol/L. |
| Method Comparison (Accuracy vs. Siemens VISTA ISE) | Linear regression analysis (slope, intercept, R²) indicating strong correlation and minimal bias. Slope close to 1, Intercept close to 0, R² close to 1. | |
| - Site 1 Whole Blood (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.12, R²: 0.969 |
| - Site 1 Plasma (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.03, R²: 0.979 |
| - Site 1 Serum (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.06, R²: 0.979 |
| - Site 2 Whole Blood (N=130) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.99, Intercept: 0.13, R²: 0.969 |
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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