(147 days)
The SMARTLYTE is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples. In addition, the analyzer can also measure sodium, chloride and calcium in dialysate samples.
The SMARTLYTE Sodium Assay is intended to measure sodium in whole blood, serum, plasma, pre-diluted urine and dialysate on the SMARTLYTE Electrolyte Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SMARTLYTE Potassium Assay is intended to measure potassium in whole blood, serum, plasma, urine and dialysate. 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.
The SMARTLYTE Chloride Assay is intended to measure the level of chloride in whole blood, serum, plasma, urine and dialysate. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SMARTLYTE Calcium Assay is intended to measure ionized calcium levels in whole blood, plasma, serum, and dialysate. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SMARTLYTE Lithium Assay is intended to measure lithium (from the drug lithium carbonate) in whole blood, plasma, and serum. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
The SMARTLYTE Nat, K", CT, Ca*, Li Electrolyte Analyzer which can test serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials is identical to GEMLYTE Electrolyte Analyzer ( cleared under K082462) which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Both are microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, dialysate solutions and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours through out the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. Mission controls (510 (k) 033063) are the recommended . quality control material to be used daily.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them, based on your requested format:
Acceptance Criteria and Device Performance Study for SMARTLYTE Electrolyte Analyzer
The SMARTLYTE Electrolyte Analyzer is an automated, microprocessor-controlled device using ion-selective electrodes to measure sodium, potassium, chloride, calcium, and lithium in various sample types, including dialysate. The study aimed to demonstrate the substantial equivalence of the SMARTLYTE to its predicate device, the AVL 9180 (K961458), particularly for dialysate measurements, which represent a modification from previously cleared uses.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's performance characteristics or defined in the "Reproducibility" section as maximum allowable CVs or SDs. The reported device performance is from the "Precision Dialysate" and "Dialysate Comparison" sections.
Note on Acceptance Criteria: The document primarily compares the SMARTLYTE's performance to the predicate device's expected values and establishes its own internal precision targets. For the method comparison, "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.96 and 1.04" serves as a key acceptance criterion for the clinical claims (correlation with a predicate device). For precision, specific CV/SD targets are given.
| Parameters | Matrix | Acceptance Criteria (Predicate/Target) | Reported Device Performance (SMARTLYTE) |
|---|---|---|---|
| Precision | |||
| Na+ | Dialysate | Within Run C.V. ≤ 1% | |
| Between Run C.V. ≤ 2% | Within Run C.V.: 0.32-0.47% | ||
| Between Run C.V.: 0.32-0.54% | |||
| K+ | Dialysate | Within Run C.V. ≤ 2% | |
| Between Run C.V. ≤ 3% | Within Run C.V.: 0.28-0.87% | ||
| Between Run C.V.: 0.88-1.27% | |||
| Cl- | Dialysate | Within Run C.V. ≤ 2% | |
| Between Run C.V. ≤ 3% | Within Run C.V.: 0.24-0.89% | ||
| Between Run C.V.: 0.53-1.44% | |||
| Ca++ | Dialysate | Within Run SD ≤ 0.02 | |
| Between Run SD ≤ 0.06 | Within Run SD: 0.0087-0.0155 (CV not calculated in source) | ||
| Between Run SD: 0.0076-0.0226 (CV not calculated in source) | |||
| Na+ | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% (Predicate: ≤ 7%) | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| K+ | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| Cl- | Urine | Within Run C.V. ≤ 5% | |
| Between Run C.V. ≤ 5% | (Not explicitly reported in this document for Urine; previously cleared K082462) | ||
| Linearity | Dialysate | R-squared ≈ 0.99 (implied by "good correlation") | Sodium: 0.9995 |
| Potassium: 0.9976 | |||
| Chloride: 0.9998 | |||
| Calcium: 0.9972 | |||
| Slope ≈ 1 (implied) | Sodium: 0.9806 | ||
| Potassium: 1.0031 | |||
| Chloride: 0.9996 | |||
| Calcium: 0.9857 | |||
| Intercept ≈ 0 (implied) | Sodium: 2.53 | ||
| Potassium: -0.37 | |||
| Chloride: 1.60 | |||
| Calcium: 0.06 | |||
| Method Comparison (to predicate AVL 9180) | Dialysate | R > 0.99, Slope 0.96-1.04 (Stated by manufacturer) | Sodium: R=0.9989, Slope=1.0183 |
| Potassium: R=0.9996, Slope=0.9882 | |||
| Chloride: R=0.9966, Slope=0.9825 | |||
| Calcium: R=0.9956, Slope=1.0021 | |||
| Measuring Range | Dialysate | Na: 40-205 mEq/L | |
| K: 1.7-15 mEq/L | |||
| Cl: 50-200 mEq/L | |||
| Ca: 0.3-5.5 mmol/L (Predicate range) | Na: 40-200 mEq/L (Linearity confirmed: 24-205); Method comparison supported: 40-205 mEq/L | ||
| K: 1.7-15 mEq/L (Linearity confirmed: 1.4-15.1); Method comparison supported: 1.7-11 mEq/L | |||
| Cl: 50-200 mEq/L (Linearity confirmed: 40-202); Method comparison supported: 50-205 mEq/L | |||
| Ca: 0.3-5.5 mmol/L (Linearity confirmed: 0.4-5.0); Method comparison supported: 0.3-5.5 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Precision (Dialysate):
- Within-run: 30 replicates for each of three dialysate samples (low, mid, high concentrations) per measurand.
- Between-run (Total precision): 40 replicates (4 groups of 10 replicates over 10 days) for each of three dialysate samples per measurand.
- Linearity (Dialysate):
- Sodium: 34 samples
- Potassium: 36 samples
- Chloride: 34 samples
- Calcium: 48 samples
- Method Comparison (Dialysate):
- Sodium: 43 samples
- Potassium: 56 samples
- Chloride: 51 samples
- Calcium: 43 samples
Data Provenance: The document implies these were prospective studies conducted to support the 510(k) submission for the specific device modifications. No explicit country of origin is stated for data collection, but given it's a US FDA submission, it's typically assumed to be North American or adhering to international standards accepted by the FDA. The samples were "dialysates collected" and some were "spiked or diluted" to span the measurement ranges, suggesting a mix of clinical and artificially prepared samples. Prior data for whole blood, serum, plasma, and urine were "previously cleared (K082462)".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in-vitro diagnostic device measuring analytes. The "ground truth" for the test set is established by the reference methods or the predicate device that the SMARTLYTE is compared against, not by human expert assessment of images or clinical cases. The reference for comparison would be the AVL 9180 predicate device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 for consensus among experts) are used in studies involving human interpretation or subjective assessments. This study evaluates the analytical performance of an IVD device against a predicate or defined analytical targets.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases with and without AI assistance to measure a change in human performance (e.g., diagnostic accuracy, reading time). The SMARTLYTE is an automated IVD device; it does not involve human readers interpreting output in the same way an imaging AI would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (precision, linearity, method comparison) represent standalone performance of the SMARTLYTE device. The device operates automatically to measure analyte concentrations. The "human-in-the-loop" aspect is limited to operating the device and collecting samples, not interpreting an AI's output to make a diagnosis.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies can be defined as:
- Reference Intervals/Expected Values: For linearity studies, expected values based on known dilutions of stock solutions serve as the ground truth.
- Predicate Device Measurements: For the method comparison study, the measurements from the predicate device (AVL 9180) on the same dialysate samples served as the comparative ground truth.
- Internal Precision Targets: For the precision studies, the acceptance criteria (max CV/SD) are internal performance targets, and the reported values are measured against these.
8. The Sample Size for the Training Set
Not applicable. The SMARTLYTE Electrolyte Analyzer is an IVD device based on ion-selective electrode technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its hardware, chemistry, and pre-programmed algorithms, which are calibrated and verified through analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's technology. The device uses established physical and chemical principles (ion-selective electrodes). Calibrations are performed using certified calibration fluids.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. 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.(b)
Classification. Class II.