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510(k) Data Aggregation
(284 days)
The SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in vitro diagnostic use only.
The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.
Acceptance Criteria and Device Performance for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
The provided text details the performance evaluation of the SelectaLyte Electrolyte Analyzer as part of its 510(k) premarket notification. The acceptance criteria and the device's performance are primarily demonstrated through studies on precision, linearity, method correlation, and interference.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values in table format (e.g., "CV must be < X%"). However, the acceptance for each study is implicitly demonstrated by the successful completion of the CLSI (Clinical and Laboratory Standards Institute) guidelines and the reported results falling within acceptable laboratory practice (e.g., correlation coefficients close to 1, small biases relative to the predicate device, acceptable precision metrics). The "Reportable Range" serves as a key acceptance criterion for linearity and method correlation.
Here's a summary of the reported device performance, which implies that these values met the internal acceptance criteria for substantial equivalence:
Table 1: Reported Device Performance
| Study Type | Analyte | Matrix | Key Performance Metric (Accepted Value / Reported Value) |
|---|---|---|---|
| Precision | Sodium | Human Serum | Within-Lab CV: (0.82% @ 95.2), (0.54% @ 134.7), (0.84% @ 178.8) mmol/L |
| Within-Lab SD: (0.78), (0.72), (1.51) mmol/L | |||
| Sodium | Whole Blood | Within-Lab CV: (0.43% @ 98.9), (0.24% @ 136.8), (0.14% @ 161.0) mmol/L | |
| Within-Lab SD: (0.42), (0.32), (0.23) mmol/L | |||
| Potassium | Human Serum | Within-Lab CV: (0.79% @ 2.77), (0.78% @ 4.01), (0.97% @ 6.59) mmol/L | |
| Within-Lab SD: (0.02), (0.03), (0.06) mmol/L | |||
| Potassium | Whole Blood | Within-Lab CV: (1.27% @ 2.14), (2.07% @ 3.29), (1.07% @ 7.78) mmol/L | |
| Within-Lab SD: (0.03), (0.07), (0.08) mmol/L | |||
| Chloride | Human Serum | Within-Lab CV: (0.91% @ 63.2), (0.82% @ 90.1), (0.93% @ 114.4) mmol/L | |
| Within-Lab SD: (0.58), (0.74), (1.06) mmol/L | |||
| Chloride | Whole Blood | Within-Lab CV: (0.81% @ 69.5), (0.50% @ 104.4), (0.40% @ 129.9) mmol/L | |
| Within-Lab SD: (0.57), (0.52), (0.53) mmol/L | |||
| Linearity | Sodium | Serum | Correlation Coefficient: 0.9988; Tested Range: 35.9-203.5 mmol/L; Reportable Range: 40-205 mmol/L |
| Potassium | Serum | Correlation Coefficient: 0.9999; Tested Range: 1.26-19.62 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Serum | Correlation Coefficient: 0.9999; Tested Range: 30.1-202.3 mmol/L; Reportable Range: 50-200 mmol/L | |
| Sodium | Whole Blood | Correlation Coefficient: 0.9995; Tested Range: 33-217.5 mmol/L; Reportable Range: 40-205 mmol/L | |
| Potassium | Whole Blood | Correlation Coefficient: 0.9993; Tested Range: 1.45-18.49 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Whole Blood | Correlation Coefficient: 1.0000; Tested Range: 33.4-214.6 mmol/L; Reportable Range: 50-200 mmol/L | |
| Method Correlation | Sodium | Serum | R^2: 0.9869; Syx: 2.37; Tested Range: 43.3-194.2 mmol/L; Reportable Range: 40-205 mmol/L |
| Potassium | Serum | R^2: 0.9959; Syx: 2.37; Tested Range: 1.51-14.72 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Serum | R^2: 0.9854; Syx: 2.36; Tested Range: 55.0-192.6 mmol/L; Reportable Range: 50-200 mmol/L | |
| Sodium | Whole Blood | R^2: 0.9865; Syx: 1.91; Tested Range: 43.3-204.6 mmol/L; Reportable Range: 40-205 mmol/L | |
| Potassium | Whole Blood | R^2: 0.9946; Syx: 1.91; Tested Range: 1.58-14.84 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Whole Blood | R^2: 0.9806; Syx: 1.88; Tested Range: 53.0-192.2 mmol/L; Reportable Range: 50-200 mmol/L | |
| Interference | All | Serum | Highest concentrations of listed interferents tested did not show significant interference (unless explicitly stated otherwise in "Observations" section) |
| All | Whole Blood | Highest concentrations of listed interferents tested did not show significant interference (unless explicitly stated otherwise in "Observations" section) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum: N=80 for each of three levels of pooled human serum, for each analyte (Sodium, Potassium, Chloride). (2 machines, multiple users, 2 runs/day over 20 days = 80 measurements).
- Whole Blood: N=40 for each of three levels of pooled human whole blood, for each analyte (Sodium, Potassium, Chloride). (40 replicates per sample after calibrations every 10 consecutive replicates).
- Linearity Study:
- Serum: 4 replicates at each level, over 10 or 11 levels of concentration for each analyte. (e.g., Sodium: 10 levels * 4 replicates = 40 samples).
- Whole Blood: 4 replicates at each level, over 10 or 11 levels of concentration for each analyte. (e.g., Sodium: 11 levels * 4 replicates = 44 samples).
- Method Correlation Study:
- N=100 samples (serum and whole blood, respectively) for each analyte compared to the predicate device (AVL 9180 Electrolyte Analyzer). 10% of samples were spiked or diluted to span the claimed measuring ranges.
- Interference Study:
- The number of samples for the interference study is not explicitly stated as a single "N". Multiple interferent substances were tested at various concentrations. The methodology follows CLSI EP07-A2. The highest concentration that did not show significant interference is reported.
Data Provenance: The document does not explicitly state the country of origin of the human serum or whole blood samples. It mentions "Pooled Human Serum" or "Human Whole Blood." The studies are retrospective as they were conducted as part of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This device is an in vitro diagnostic (IVD) electrolyte analyzer. The "ground truth" for the test set is established by the analytical reference methods or predicate device measurements, not by human expert interpretation (e.g., radiologists reading images). Therefore, there were no "experts" in the sense of medical professionals adjudicating diagnostic test results for the test set.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device test. The "truth" is determined by the analytical performance of the device against reference methods or the legally marketed predicate device, as per CLSI guidelines, rather than human consensus or adjudication of clinical interpretations.
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 is primarily relevant for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. For an IVD device like the SelectaLyte Electrolyte Analyzer, performance is assessed through analytical studies (precision, linearity, correlation) comparing the device's measurements to established standards or a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Precision, Linearity, Method Correlation, Interference) are all "standalone" in nature for an IVD device. They evaluate the analytical performance of the SelectaLyte Electrolyte Analyzer itself, independent of immediate human interpretation of results, beyond the standard operation by a trained professional in a clinical laboratory. The device outputs numerical values for Na+, K+, and Cl-, and these values are compared to known concentrations or predicate device results.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation varied by study:
- Precision: The ground truth is the inherent concentration of the analyte within the stable, homogeneous pooled human serum or whole blood samples, and the consistency of repeated measurements.
- Linearity: The ground truth is established by accurately prepared intermediate concentration samples through proportional mixing of high and low concentration pools, aiming for known, linearly distributed concentrations.
- Method Correlation: The ground truth is the measurements obtained from the legally marketed predicate device (AVL 9180 Electrolyte Analyzer). This demonstrates substantial equivalence.
- Interference: The ground truth is the expected analyte concentration in the presence of various potentially interfering substances, assessed against a baseline without the interferent, looking for significant bias.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or "validation set" in the context of machine learning. This is a traditional IVD device, not an AI/ML-driven device. The studies described are validation studies performed on the final device to demonstrate its performance characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this document describes the validation of a traditional IVD device, not the development or training of an AI/ML model. Therefore, there is no "training set" in the machine learning sense, nor is there ground truth established for such a set.
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(277 days)
ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.
ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.
This is an FDA Premarket Notification (510(k)) decision letter. It states that the device, 'ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits', is substantially equivalent to a predicate device. This letter does not include acceptance criteria or a study proving the device meets acceptance criteria. It mentions the indications for use, but no performance data. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details.
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(61 days)
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(40 days)
This accessory program may be used by customers with the general purpose analyzer (K882938) who want to link their instrument to a PC for the purpose of transferring the data from the general purpose instrument to the PC, instead of having the data typed manually by a data entry person
Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Stat Tracks device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design will produce intended results. | "Stat Tracks has been tested to verify that the design will produce intended results." |
| Activation of appropriate error messages. | "Studies confirm activation of appropriate error messages as well." |
| No device-induced case of mis-identification of a patient result. | "No device-induced case of mis-identification of a patient result has been found under any circumstance of testing." |
| Device is comparable to other commercially available software and manual methods for data handling. | "Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing." (This is a statement of equivalence, not a direct performance metric, but relevant to the overall acceptance of the device's function). |
| Facilitate the lab worker's job, mainly by saving time and money. | While not a direct acceptance criterion reported with performance data, the "USE OF THE DEVICE" section states this as the device's purpose, implying it was an intended outcome of the design. The text doesn't quantify this saving. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Design Assurance Testing" and that "Stat Tracks has been tested," but does not provide details on the number of tests, cases, or scenarios included in this testing.
- Data Provenance: Not specified. It's likely that the testing was internal to Awareness Technology, Inc., given the nature of a software interface. There's no indication of independent testing or specific geographical origin beyond the company's location in Palm City, FL, USA. The testing appears to be prospective in the sense that it was conducted as part of the device's development and verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The testing would have likely involved "laboratory professionals" as they are the intended users, but their specific qualifications for evaluating the software's performance are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a software interface for data transfer, it's unlikely that a formal adjudication process involving multiple readers was employed in the same way it would be for diagnostic image interpretation. The testing likely focused on functional verification and error checking.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document describes a software tool for data transfer, not a diagnostic aid that would typically involve human readers interpreting complex cases. The comparison is made to "other commercially available software" and "manual methods," but this is a statement of equivalence rather than a formal MRMC study.
- Effect Size of Human Reader Improvement with AI vs. Without AI Assistance: Not applicable, as this was not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was done. The "Design Assurance Testing" described is essentially a standalone assessment of the software's functionality, focusing on whether it produces intended results, activates error messages, and avoids patient mis-identification. The device's primary function is to automate data transfer, which it does without direct human intervention during the transfer process itself (though a human initiates it). The phrase "No device-induced case of mis-identification of a patient result has been found under any circumstance of testing" directly refers to the algorithm's standalone performance in preventing errors.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device appears to be defined by:
- Functional correctness: Whether data is transferred accurately and as intended.
- Error message activation: Whether specific error conditions correctly trigger appropriate messages.
- Absence of data mis-identification: Verifying that patient results are not mistakenly linked to the wrong patient or test.
- This is essentially a form of functional verification against predefined specifications and expected outputs.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a software interface and reporting tool, not a machine learning or artificial intelligence algorithm that requires a "training set" in the conventional sense. Its "training" would be its development and debugging process.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no traditional "training set" for this type of software. The "ground truth" for the software's development would be its functional specifications and adherence to programming logic.
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