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510(k) Data Aggregation
(212 days)
The SmartLyte® Plus is an automated, microprocessor-controlled analyzer which utilizes ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in Serum, Sodium Heparin Plasma, and Venous Whole Blood, as well as measurement of sodium, potassium and chloride in pre-diluted Urine samples.
The SmartLyte® Plus Sodium Assay is intended to measure sodium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus 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® Plus Potassum Assay is intended to measure potassium in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. 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® Plus Chloride Assay is intended to measure the level of chloride in Venous Whole Blood, Serum, Sodium Heparin Plasma, and Urine on the SmartLyte® Plus Electrolyte Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SmartLyte® Plus Calcium Assay is intended to measure ionized calcium levels in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. 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® Plus Lithium Assay is intended to measure lithium carbonate) in Venous Whole Blood, Sodium Heparin Plasma, and Serum on the SmartLyte® Plus Electrolyte Analyzer. Measurements of ithium are used to assure that the proper drug dosage is administered in the treatment with mental disturbances, such as manic-depressive illness (bipolar disorder).
For in-vitro diagnostic use only.
The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which can test Serum, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials is substantially equivalent to it's predicate SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests Serum, Sodium Heparin Plasma, Venous 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, Sodium Heparin Plasma, Venous Whole Blood, pre-diluted Urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack (510(k) 013850) every 4 hours throughout 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.
The SmartLyte® Plus is intended to be a direct replacement for the SmartLyte® Electrolyte Analyzer (K082462).
The SmartLyte® Plus Electrolyte Analyzer is designed for clinical laboratory professionals to assess the levels of Sodium, Potassium, Chloride, Calcium and Lithium found in Venous Whole Blood, Sodium Heparin Plasma, Serum, and Urine of patients. The analysis is performed in-vitro, and neither the analyzer nor any of its components come in contact with the patient.
The document describes the performance of the SmartLyte® Plus Electrolyte Analyzer. This device is an in-vitro diagnostic instrument, and the provided information details its analytical performance characteristics rather than the performance of an AI algorithm with human readers or a medical imaging device. Therefore, many of the requested points related to AI, MRMC studies, human experts, and ground truth establishment for complex data like images are not directly applicable or available in this document.
However, I can extract and present the acceptance criteria and reported device performance for the SmartLyte® Plus Electrolyte Analyzer as it relates to its analytical accuracy and precision.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents performance data for Precision and Linearity for each analyte (Na+, K+, Cl-, Ca++, Li+) across different sample types (Serum, Plasma, Whole Blood, Urine). The acceptance criteria are implicitly quantitative, as the 'Status' for each test is reported as "Pass" against numerical criteria.
1. Table of Acceptance Criteria and Reported Device Performance (Summary)
Since the document provides extensive tables for precision (within-run and run-to-run) and linearity for each analyte and matrix, I will summarize the general acceptance criteria and indicate that the device passed all these criteria as reported in the document. Presenting every single data point for all analytes and matrices would be too large for this format.
Precision (for Serum/Blood/Plasma)
| Analyte | Within Run Criterion (CV or SD) | Between Run Criterion (CV or SD) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 1% | CV ≤ 2% | Pass |
| K+ | CV ≤ 1.5% | CV ≤ 3% | Pass |
| Cl- | CV ≤ 1% | CV ≤ 3% | Pass |
| Ca++ | SD ≤ 0.02 | SD ≤ 0.06 | Pass |
| Li+ | SD ≤ 0.03 | SD ≤ 0.09 | Pass |
Precision (for Urine)
| Analyte | Within Run Criterion (CV) | Between Run Criterion (CV) | Device Performance (Status) |
|---|---|---|---|
| Na+ | CV ≤ 5% | CV ≤ 5% | Pass |
| K+ | CV ≤ 5% | CV ≤ 5% | Pass |
| Cl- | CV ≤ 5% | CV ≤ 5% | Pass |
Linearity (General Acceptance Criterion)
| Performance Metric | Implicit Acceptance Criteria | Device Performance (Status) |
|---|---|---|
| Slope | Near 1.0 (actual ranges provided in tables are typically 0.97 to 1.03) | Achieved (Values reported) |
| Intercept | Near 0.0 (actual values reported) | Achieved (Values reported) |
| R² (Coefficient of Determination) | High value, typically > 0.99 (actual values reported are 0.9939 to 0.9997, indicating strong linear correlation) | Achieved (Values reported) |
| Reportable Range | The linearity studies supported the claimed measurement ranges for each analyte and matrix. | Supported |
Detection Limit
| Analyte | Acceptance Criteria for %TE | Claimed Measurement Range | Device Performance (%TE) | Device Performance (Status) |
|---|---|---|---|---|
| Ca++ | 21.6% | 0.3 - 5.0 mmol/L | 5.541% - 11.868% | Pass (LoQ < Range min) |
| Li+ | 21.6% | 0.2 - 6.0 mmol/L / 0.2-5.5 mmol/L | 6.208% - 14.085% | Pass (LoQ < Range min) |
Method Comparison (General Acceptance Criterion)
The criteria for method comparison are implicitly that the SmartLyte® Plus shows a "good correlation to predicate with correlation coefficients typically greater than 0.99 and slope values between 0.97 and 1.03."
The documented R² values are all greater than 0.99 (ranging from 0.9939 to 0.9987), and slope values are indeed within 0.97 and 1.03.
Study that Proves the Device Meets Acceptance Criteria:
The document describes several non-clinical and clinical tests performed to demonstrate that the SmartLyte® Plus Electrolyte Analyzer meets its performance claims and is substantially equivalent to its predicate device (SmartLyte® K082462).
2. Sample Size and Data Provenance:
- Precision Test Set Sample Sizes:
- Within Run: 30 replicates (n=30) for each sample type (Serum, Plasma, Whole Blood, Urine) and analyte.
- Between Run/Total Precision:
- Serum/Plasma/Urine: Duplicate measurements over 20 days (total of 40 replicates).
- Venous Whole Blood: 20 samples from 2 instruments over a 2-hour period (total of 40 replicates).
- Linearity Test Set Sample Sizes (n):
- Serum: Sodium (48), Potassium (75), Chloride (45), Calcium (72), Lithium (70)
- Plasma: Sodium (75), Potassium (75), Chloride (39), Calcium (42), Lithium (42)
- Whole Blood: Sodium (54), Potassium (69), Chloride (42), Calcium (52), Lithium (39)
- Urine: Sodium (19), Potassium (19), Chloride (19)
- Method Comparison Test Set Sample Sizes (n):
- Serum: 109-125 samples per analyte
- Plasma: 110-125 samples per analyte
- Whole Blood: 108-112 samples per analyte
- Urine: 115-118 samples per analyte
- Data Provenance: The document does not specify the country of origin of the data. It indicates that samples were collected for testing. The nature of the study (analytical performance of a medical device) typically implies controlled laboratory conditions rather than broad population-based data. The studies are described as "non-clinical" and "clinical tests," but the "clinical" aspect refers to using human biological samples for analytical validation in a lab setting, not a direct patient outcome study. The studies appear to be prospective, designed specifically for this 510(k) submission.
3. Number of Experts and Qualifications: Not applicable. This is an analytical performance study of an in-vitro diagnostic device, not an image-based AI study requiring expert readers for ground truth establishment. The performance is assessed against quantitative measurements and statistical methods (CLSI guidelines).
4. Adjudication Method: Not applicable. (See #3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, not applicable. This is not an AI-assisted diagnostic imaging device study. The device functions as a standalone analyzer that measures electrolyte concentrations. Its "comparison" is against a predicate device (another equivalent analyzer), not human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone analyzer. Its performance is measured as output values (mmol/L) directly from the instrument. The 'algorithm' here refers to the internal software and hardware that processes the ion-selective electrode signals to produce the final measurement. The performance data presented (precision, linearity, detection limit, method comparison) are the standalone performance of the device.
7. The type of ground truth used:
- For Precision, Linearity, and Detection Limit: The "ground truth" or reference for these studies refers to the accurate measurement of known concentrations in control materials or diluted stock solutions (for linearity), and statistical evaluation of repeatability. For detection limit, reference to a "reference analyzer (Flame Photometer SN 86011421)" is made for target values.
- For Method Comparison: The "ground truth" for the method comparison study was established by comparing the results of the SmartLyte® Plus Analyzer to those obtained from the predicate device, SmartLyte® (K082462), implying the predicate device serves as the established reference for comparison.
8. The Sample Size for the Training Set: Not applicable in the context of typical AI/ML model training. This is an analytical instrument, not a learning algorithm that requires a separate "training set" of data in the AI sense. The development of the device's measurement principles and internal parameters would rely on established chemical and engineering principles and internal validation.
9. How the ground truth for the training set was established: Not applicable for the reasons stated in #8. The device's "training" is its design, calibration, and validation processes based on quantitative chemical and electrical measurement principles, not from a data-driven learning approach. Calibration standards traceable to NIST (National Institute of Standards and Technology) are used for the actual device calibration.
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(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.
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