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510(k) Data Aggregation
(592 days)
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances.
Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (Ca++) (ionized) 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).
Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor, used in the calculation of the patient sample.
The analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯.
The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.
Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days.
The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC.
The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.
The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material information. Details are provided in the operator's Manual.
To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.
Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.
| Study Type | Analyte | Acceptance Criteria / Performance Specification | Reported Device Performance (Summary from text) |
|---|---|---|---|
| 20-Day Precision (Aqueous Controls) | Cl- (Repeatability) | Level 1: SD 2.0 | Level 1: SD ~0.04-0.05 |
| Cl- (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.0% | |
| Cl- (Repeatability) | Level 3: 1.7% CV | Level 3: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 1: SD 2.5 | Level 1: SD ~0.13-0.24 | |
| Cl- (Within-Device Total) | Level 2: 1.8% CV | Level 2: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 3: 2.0% CV | Level 3: CV ~0.1% | |
| Ca++ (Repeatability) | Level 1: 2.0% CV | Level 1: CV ~0.1-0.2% | |
| Ca++ (Repeatability) | Level 2: 2.0% CV | Level 2: CV ~0.0-0.4% | |
| Ca++ (Repeatability) | Level 3: SD 0.02 | Level 3: SD ~0.00 | |
| Ca++ (Within-Device Total) | Level 1: 2.5% CV | Level 1: CV ~0.1-0.3% | |
| Ca++ (Within-Device Total) | Level 2: 2.5% CV | Level 2: CV ~0.0-0.5% | |
| Ca++ (Within-Device Total) | Level 3: SD 0.03 | Level 3: SD ~0.00 | |
| K+ (Repeatability) | Level 1: SD 0.07 | Level 1: SD ~0.00 | |
| K+ (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.1-0.2% | |
| K+ (Repeatability) | Level 3: 2.0% CV | Level 3: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 1: SD 0.10 | Level 1: SD ~0.00-0.01 | |
| K+ (Within-Device Total) | Level 2: 2.0% CV | Level 2: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 3: 2.5% CV | Level 3: CV ~0.1-0.4% | |
| 5-Day Repeatability (Whole Blood) | Cl- | All results within specification (implied from 20-day aqueous specs, though not explicitly restated for whole blood) | CVs generally 0.1-0.5% |
| Ca++ | All results within specification | CVs generally 0.2-1.0% (SDs 0.000-0.024) | |
| K+ | All results within specification | CVs generally 0.3-1.2% (SDs 0.006-0.093) | |
| Linearity Study | Cl-, Ca++, K+ | All analytes linear within the advertised reportable range (PASS in table) | All analytes demonstrated linearity with R2 values close to 1.000 (e.g., K+ 0.999-1.000, Ca++ 0.999-1.000, Cl- 0.999-1.000) |
| Method Comparison Study | K+ (e.g. at 3.00 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.016 (CI 3.01-3.02), Total Allowable Error 2.50-3.50. Status: PASS |
| Cl- (e.g. at 90.0 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.25 (CI 90.1-90.4), Total Allowable Error 85.5-94.5. Status: PASS | |
| Ca++ (e.g. at 0.37 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias -0.022 (CI 0.34-0.35), Total Allowable Error 0.27-0.47. Status: PASS | |
| Sensitivity Study | K+ | LoQ < Lowest Detection Limit (LDL) | LoQ = 0.20 mmol/L, LDL = 1.00 mmol/L (LoQ < LDL - Yes) |
| Ca++ | LoQ < Lowest Detection Limit (LDL) | LoQ = 0.25 mmol/L, LDL = 0.25 mmol/L (LoQ < LDL - Yes) | |
| Cl- | LoQ < Lowest Detection Limit (LDL) | LoQ = 42.4 mmol/L, LDL = 50.0 mmol/L (LoQ < LDL - Yes) | |
| Selectivity Study | K+, Cl-, Ca++ | No Interference when change < Total Allowable Error (TAE) of nominal value (e.g., K+ <0.30 mmol/L or < ±7%) | Many substances showed "No Interference" (Table I). Some interferents identified with specific biases and concentrations (Table II). The document implies acceptance if interferences are within defined limits or characterized. |
The "Performance Conclusions" section on page 6 and 15 state that the device "performs equivalently to the predicate device" and is "safe and effective for its intended purpose and equivalent in performance to the reference device," implying all acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies (Aqueous Controls):
- Each of the three quality control levels (tri-level aqueous EasyQC material) was analyzed.
- Tested in three EasyStat 300 analyzers.
- Tested for twenty days.
- Duplicate readings in the morning (AM) and afternoon (PM).
- Total samples: 3 (levels) * 3 (analyzers) * 20 (days) * 2 (readings/day) = 360 data points per analyte for aqueous controls.
- Provenance: "in a laboratory setting (Bench test)" using "aqueous controls."
- Repeatability (5-Day) Study – Whole Blood Samples:
- Five replicates of whole blood samples.
- Tested over five days.
- Number of distinct whole blood samples is not explicitly stated, but it was "whole blood from adult volunteers."
- Provenance: "venous whole blood from adult volunteers," "in a laboratory setting (Bench test)."
- Linearity Study:
- Nine (9) to eleven (11) spiked and diluted whole blood specimens per analyte.
- Tested on three EasyStat 300 analyzers.
- Tested in triplicate.
- Total samples: (9 to 11) * 3 (analytes) * 3 (analyzers) * 3 (replicates) = approximately 243 to 297 data points.
- Provenance: "spiked and diluted whole blood specimens."
- Method Comparison Study:
- 192 donors.
- Six modified whole blood samples (spiked and diluted).
- Total of 198 samples.
- Tested on the reference device twice.
- Tested on three EasyStat 300 analyzers in duplicate.
- Total samples: 198 (unique samples).
- Provenance: "whole blood from 192 donors plus six modified whole blood samples (spiked and diluted)." The donors' country of origin is not specified, but the study was conducted "in a laboratory setting (Bench test)." This is a prospective collection for the study.
- Sensitivity Study:
- Performed on three ES 300 analyzers.
- Specific number of blanks/low-concentration samples not explicitly stated but implies sufficient measurements as per CLSI EP17-A.
- Provenance: Not specified, but likely laboratory-prepared samples.
- Selectivity Study:
- Provenance: "spiked whole blood samples collected from healthy donors." Country/origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes performance studies for an in-vitro diagnostic device that measures potassium, calcium, and chloride levels. The "ground truth" for such devices is typically established by:
- Reference methods/predicate devices.
- Certified reference materials.
- Laboratory-prepared controls with known concentrations.
The document states:
- For the Method Comparison Study, the "reference analyzer was the EasyStat, K063376."
- For Precision Studies, "EasyStat 300 tri-level aqueous EasyQC material" was used, implying certified or well-characterized control materials.
- For Linearity, "pre-assayed whole blood samples" were used.
Therefore, the ground truth was established by:
- A predicate device/reference analyzer (EasyStat, K063376).
- Certified/characterized quality control materials (EasyQC material).
- Pre-assayed/spiked laboratory samples.
There is no mention of "experts" in the context of clinical interpretation or subjective assessment to establish ground truth because this is a quantitative measurement device, not an image-based or qualitative diagnostic. The "experts" in this context would be the technicians operating the reference methods and preparing the samples, ensuring accurate measurement. Their specific qualifications are not detailed beyond "trained technicians in clinical laboratories" mentioned in the Indications for Use.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for studies where subjective interpretation is involved, such as reading medical images, to establish a consensus ground truth.
For the EasyStat 300, which is a quantitative measurement device, the "ground truth" is established through:
- Reference instrument measurements.
- Known concentrations of control materials.
- Statistical comparison to established methods (e.g., linear regression, bias analysis).
Therefore, no multi-reader adjudication method (like 2+1 or 3+1) was used or is relevant for these types of analytical performance studies. The comparison is between the new device's readings and the established/known values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation (e.g., radiologists reading images with or without AI assistance).
The EasyStat 300 is an in-vitro diagnostic instrument that performs automated quantitative measurements; it does not involve human interpretation of complex data that could be augmented by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies performed for the EasyStat 300 represent standalone performance of the device. The device itself (the "algorithm" or instrumentation in this context) performs the measurements and generates results. While it requires a trained technician to operate it and load samples, the performance metrics (precision, linearity, method comparison, sensitivity) evaluate the inherent analytical capabilities of the analyzer without a human "in-the-loop" making diagnostic interpretations based on the device's output. The device provides quantitative results; it doesn't provide interpretations that a human would then refine.
7. The Type of Ground Truth Used
The ground truth used for the studies includes:
- Reference method/predicate device measurements: For the Method Comparison study, the "EasyStat, K063376" was the reference analyzer.
- Reference materials/known concentrations: "Tri-level aqueous EasyQC material" and "spiked and diluted whole blood specimens" with known or established values were used for precision, linearity, and sensitivity studies.
- Venous whole blood from adult volunteers and healthy donors: Used for precision and selectivity studies, where the measurements were compared against expected ranges or changes from a baseline.
8. The Sample Size for the Training Set
The provided document describes analytical validation studies for regulatory submission (510(k)) of an in-vitro diagnostic device. These types of submissions typically focus on analytical performance testing rather than machine learning model validation with distinct "training" and "test" sets. The EasyStat 300 is an instrument using "Ion Selective Electrode" (ISE) sensors and doesn't explicitly describe a machine learning algorithm that undergoes a training phase in the context of this document.
Therefore, the concept of a "training set" in the context of artificial intelligence/machine learning is not applicable to this device as described. The document does not mention any training data or set used for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" identified for an AI/ML algorithm in the provided document, the question of how its ground truth was established is not applicable. The device's performance relies on its hardware (ISE sensors) and predefined algorithms for calculation and calibration, not on a machine learning model trained on a data set.
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