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510(k) Data Aggregation
(903 days)
Ask a specific question about this device
(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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(617 days)
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.
Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.
The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. 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 EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. 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. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.
Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.
Key Findings from the Document:
- Device: EasyStat 300 Blood Gas Analyzer
- Purpose: Measures pO2, pCO2, and pH in whole blood.
- Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
- Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
- Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.
| Assay Category | Acceptance Criteria (Performance Specs) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | ||
| Repeatability | pO2: Level 1: 2.5 SD; Level 2: 2.5 SD; Level 3: 2.5% CV | Aqueous Controls (Syringe Mode): All results "within specification." Examples:- System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)- System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)- System 1 pH Level 1: 0.002 SD (vs 0.020 SD)Aqueous Controls (Capillary Mode): All results "within specification." Examples:- Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)- Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)- Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
| Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples:- PO2 Level 1: 0.6 SD (vs 2.5mmHg)- PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)- pH Level 1: 0.007 SD (vs 0.015 units)5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:- PO2 Level 1: 0.9 SD (vs 2.4mmHg)- PCO2 Level 1: 2.5 CV (vs 4.0% CV)- pH Level 1: 0.008 SD (vs 0.015 units) |
| Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7):- PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)- PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)- pH (Syringe): R² 0.996, Slope 1.008 (PASS)Conclusion: "all analytes... are linear within the advertised reportable range." |
| Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode:- n=272, Slope=1.001, R²=0.999- Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
| Sensitivity | LoQ < Lowest Detection Limit (LDL) for each analyte | All LoQ values are less than their respective LDLs.- pO2: LoQ 4 mmHg < LDL 5 mmHg (Yes)- pCO2: LoQ 4.6 mmHg < LDL 5.0 mmHg (Yes)- pH: LoQ 6.498 pH units < LDL 6.800 pH units (Yes)Conclusion: "The lower reportable limit for each assay... was based on the LoQ result... indicating that the following values may be used as the lowest limit of the reportable range... pO2: 5 mmHg; pCO2: 5.0 mmHg; pH: 6.800 units." |
| Selectivity | Change in analyte value < 10% due to interferent | All 23 tested substances (e.g., Acetaminophen, Albumin, Bilirubin, Ethanol) showed "No Interference" for pO2, pCO2, and pH across two levels (Level A and Level B), indicating changes were < 10%. |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set Sample Sizes:
- Precision (Repeatability):
- Aqueous Controls (Syringe & Capillary): 3 EasyStat 300 analyzers, 3 quality control levels, analyzed for 20 days, taking duplicate readings in the morning (AM) and afternoon (PM). This means 3 analyzers * 3 levels * 20 days * 2 readings = 360 data points per analyte.
- Precision (Reproducibility):
- Whole Blood (Syringe & Capillary): 5 replicates of whole blood for 5 days. (Implies 25 total replicates for each analyte per mode per unit, but the exact number of units is not specified for this particular study, though the previous study used 3 units).
- Linearity: 9 to 11 spiked and diluted whole blood specimens, tested in triplicate on 3 EasyStat 300 analyzers. (Yields approximately 27-33 data points per analyte per analyzer for a total of 81-99 data points per analyte).
- Method Comparison: Whole blood from "more than 200 donors," plus six modified whole blood samples. All samples were tested on the predicate devices twice and on three EasyStat 300 analyzers.
- Syringe Mode: n=272 for PO2; n=265 for PCO2; n=268 for pH.
- Capillary Mode: n=224 for PO2; n=219 for PCO2; n=216 for pH.
- Sensitivity: Performed on 3 ES 300 analyzers. The number of samples per analyzer is not explicitly stated but is typically multiple replicates of blank and low-concentration samples.
- Selectivity: The number of samples is not directly stated but involved "spiked whole blood samples collected from healthy donors" for each of the 23 interferents, tested at two "Gas/pH Levels" (A and B).
- Precision (Repeatability):
-
Data Provenance:
- The document states, "All tests on the following sections are non-clinical bench tests except for Method Comparison, which was performed on a clinical laboratory using actual venous and arterial blood."
- The non-clinical tests used "contrived venous blood of aqueous QC materials" and "tonometered w. Blood."
- Country of Origin: Not explicitly stated, but Medica Corporation is located in Bedford, MA, which suggests US origin for the company, implying the studies were likely conducted within the US or under US regulatory standards.
- Retrospective or Prospective: All studies described appear to be prospective analytical studies conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- How Ground Truth Was Established (for analytical studies): The ground truth for the test sets in these analytical studies was primarily established by:
- Reference Methods/Predicate Device: For the method comparison study, samples were run on the predicate device (EasyStat analyzer) to serve as the reference.
- Pre-assayed Materials: Linearity studies used "pre-assayed whole blood samples."
- Aqueous QC Materials: Precision studies extensively used "EasyQC tri-level aqueous material" provided by Medica itself.
- Spiking/Dilution/Tonometry: Samples were manipulated (spiked, diluted, tonometered) to cover the analytical measurement range and introduce interferents, providing a controlled "ground truth" for those specific tests.
- Known Concentrations: Sensitivity studies used the known concentrations of buffered saline or tonometered blood to determine detection limits.
These are analytical performance studies, not clinical studies involving expert interpretation of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the diagnostic interpretation sense (e.g., radiologists for imaging) does not directly apply here. The ground truth is laboratory-based and instrument-based.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
- These are analytical performance studies of a laboratory device designed to measure specific blood gas and pH values. The "test set" in this context refers to the samples run on the device, not a set of cases requiring human interpretation and multi-expert adjudication.
- The "ground truth" is established by reference methods or known concentrations, not by consensus of human experts adjudicating a clinical finding.
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
- MRMC Study: Not applicable.
- The EasyStat 300 is a blood gas analyzer, an in-vitro diagnostic (IVD) device that directly measures chemical parameters in blood. It is not an AI-assisted diagnostic imaging device or a system that requires human interpretation of complex data for diagnosis. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the entire performance evaluation described in the summary is effectively a "standalone" assessment of the EasyStat 300's analytical performance capabilities. The device processes samples and generates numerical results for pO2, pCO2, and pH without human intervention in the measurement process itself, beyond sample loading and initiation. The studies evaluate the device's accuracy, precision, linearity, sensitivity, and selectivity in producing these measurements.
7. The Type of Ground Truth Used
The ground truth used for these studies includes:
- Predicate Device Measurements: For method comparison, the results from the legally marketed predicate device (EasyStat Blood Gas Analyzer) served as the reference standard.
- Pre-assayed Whole Blood Samples: Used in linearity studies, where the expected values were established prior to testing.
- Aqueous Quality Control Materials (EasyQC): Used extensively in precision studies, these materials have known target concentrations.
- Tonometered Whole Blood: Used in sensitivity studies and for modifying samples for method comparison/linearity. Gas tonometry allows for precise control of pO2 and pCO2 levels in blood.
- Buffered Saline: Used in pH sensitivity studies as a sample with a known pH.
- Spiked and Diluted Whole Blood Samples: Used to create samples with varying known concentrations or to introduce interferents for linearity and selectivity studies.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable / Not explicitly provided for algorithm training.
- The EasyStat 300 is an IVD device based on established potentiometric and amperometric sensor technology, not a machine learning or AI-based device that typically undergoes "training" on large datasets. Its function relies on electrochemical principles and calibration, not a trained algorithm that learns from data. Therefore, the concept of a "training set" in the machine learning sense does not apply here. The device is calibrated and validated through the analytical studies described.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
- As explained above, this device does not utilize an AI/ML algorithm that requires a "training set" with established ground truth in the way medical imaging AI models do. Its "training" involves chemical and electrical calibration procedures as part of its normal operation, based on known physical and chemical principles documented in the operator's manual. The validation of its performance relies on the analytical studies against predicate devices, reference materials, and controlled samples.
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(471 days)
The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction.
The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany finternittent muscular contractions or spasms).
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to MEDICA CORPORATION for their EasyLyte Na/K/Cl/Ca Analyzer. This document primarily focuses on the regulatory aspects of the device, stating that the FDA has determined it is "substantially equivalent" to legally marketed predicate devices.
However, the letter does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the device's 510(k) submission itself, which is a much larger and more technical document than the FDA's regulatory response letter.
Therefore,Based on the provided document, I cannot accurately describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.
To answer your questions, I would need access to the actual 510(k) submission for K152327, which contains the detailed technical and clinical performance data.
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(484 days)
The EasyRA Creatine Kinase-MB (CK-MB) Reagent is intended for the quantitative determination of CK-MB activity in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements of CK-MB activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only. For prescription use only.
Medica's EasyRA C-Reactive Protein (CRP) Reagent is intended for use in the quantitative in-vitro diagnostic determination of C-reactive protein in human serum or plasma using the EasyRA clinical chemistry analyzer. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in-vitro diagnostic use only. For prescription use only.
The EasyCAL C-Reactive Protein (CRP) Calibrator Kit is used for calibrating the CRP assay on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA CRP Reagent. The CRP calibrators are used to establish points of reference that are used in the determination of values in the measurement of CRP in human serum and plasma. For in-vitro diagnostic use only. For prescription use only.
The EasyQC C-Reactive Protein (CRP) Quality Control Materials are intended for use as quality control material for the CRP turbidimetric assay, using the EasyRA CRP Reagent and calibrator kit on the EasyRA clinical chemistry analyzer. For in-vitro diagnostic use only. For prescription use only.
Not Found
This document is a letter from the FDA regarding the 510(k) premarket notification for several diagnostic reagents and related calibrator/control materials. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not performance studies.
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(175 days)
The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.
Not Found
The provided document is an FDA 510(k) clearance letter for the EasyRA Creatinine Reagent. It states that the device is substantially equivalent to a predicate device for measuring creatinine in serum and plasma.
However, this document does not contain the specific information required to answer your request about acceptance criteria and study details. The 510(k) clearance letter itself is a summary of the FDA's decision, not the full submission that would detail the performance studies and acceptance criteria.
To answer your questions, one would need access to the actual 510(k) premarket notification submission for K123586, which would include the performance data and the study design.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document confirms the device's indications for use: "The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis." but does not elaborate on the performance characteristics or the studies conducted to establish substantial equivalence.
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(89 days)
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.
The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.
The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.
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The provided text is a 510(k) premarket notification letter from the FDA regarding in vitro diagnostic (IVD) reagents for cholesterol and triglyceride measurements. It is not about an AI-powered medical device or an imaging device, and therefore, many of the requested criteria (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment for AI models) are not applicable to this type of device.
This document confirms substantial equivalence of Medica Corporation's EasyRA reagents to legally marketed predicate devices, meaning their performance characteristics are considered similar enough for market entry without requiring a full Premarket Approval (PMA) application. The assessment for IVD reagents typically focuses on analytical performance characteristics like accuracy, precision, linearity, and interference, rather than diagnostic accuracy studies involving human readers or AI algorithms.
Here's an attempt to address the points based on the provided document, noting where information is not applicable:
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A table of acceptance criteria and the reported device performance
The document itself does not contain a table of acceptance criteria or reported device performance data. This information would typically be found in the manufacturer's 510(k) submission summary, which the FDA reviews. The letter only states that the FDA reviewed the submission and found the device substantially equivalent. For IVD reagents, acceptance criteria usually relate to analytical specifications (e.g., % bias vs. a reference method, coefficient of variation for precision). -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided FDA letter. This would be detailed in the manufacturer's submission.
- Data Provenance: Not specified in the provided FDA letter. For IVD reagents, samples typically refer to human serum or plasma specimens used to validate the reagent's performance.
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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)
Not Applicable. This is an in vitro diagnostic reagent. The "ground truth" for chemical measurements like cholesterol or triglycerides is typically established by using validated reference methods (e.g., CDC reference methods, certified reference materials) or by comparing to another FDA-cleared predicate device, not by expert human interpretation like in imaging. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As explained above, this is an IVD reagent, not an imaging device requiring human adjudication of results. -
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
Not Applicable. No human readers or AI assistance are involved in the direct output of these IVD reagents. Their performance is measured analytically. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm. It's a chemical reagent for a lab analyzer. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for IVD reagents typically refers to:- Reference Methods: Highly accurate and precise laboratory methods (e.g., gas chromatography-mass spectrometry for some analytes, or established enzymatic methods traceable to reference standards).
- Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analyte.
- Comparison to Predicate Devices: Performance is often compared to another legally marketed and validated device to demonstrate "substantial equivalence."
The specific method used is not detailed in this FDA letter.
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The sample size for the training set
Not Applicable. This is not an AI device that requires a "training set" in the machine learning sense. The "training" for a chemical reagent involves its formulation and validation, which doesn't use data sets in the same way. -
How the ground truth for the training set was established
Not Applicable. As above, no training set in the AI sense.
In summary, the provided document is a regulatory clearance letter for laboratory testing reagents, not for a medical device that utilizes artificial intelligence or requires human interpretation for its primary function. Therefore, the questions related to AI models, human expert review, and related study designs (like MRMC) are not relevant to this specific product.
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