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510(k) Data Aggregation
(266 days)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).
Here's an analysis of the acceptance criteria and study details based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.
However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).
For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.
| Test Parameter | Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (i-STAT CG8+ cartridge with i-STAT 1 System) |
|---|---|---|
| Precision (Aqueous Materials) - 20 Days | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall Within-Laboratory SD typically < 0.015 mmol/L, %CV < 0.8%. Hct (%PCV): Overall Within-Laboratory SD typically < 0.5%, %CV < 2%. (See Table 2 for full details) |
| Precision (Aqueous Materials) - Multi-site/Operator | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall SD typically < 0.02 mmol/L, %CV < 1%. Hct (%PCV): Overall SD typically < 0.5%, %CV < 3.5%. (See Table 3 for full details) |
| Precision (Whole Blood) | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): SD typically < 0.022 mmol/L, %CV < 1.3%. Hct (%PCV): SD typically < 2.2%, %CV < 5.6%. (See Table 4 for full details) |
| Linearity (iCa) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 0.25 - 2.50 mmol/L Range Tested: 0.204 - 2.832 mmol/L Slope: 1.016, Intercept: 0.019, R: 0.9981 (See Table 5) |
| Linearity (Hct) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 15 - 75 %PCV Range Tested: 12.7 - 78.3 %PCV Slope: 1.031, Intercept: -0.592, R: 0.9992 (See Table 5) |
| Limit of Quantitation (LoQ) | LoQ at or below the lower limit of the reportable range. | iCa: Determined LoQ 0.15 mmol/L (Lower limit: 0.25 mmol/L) Hct: Determined LoQ 13 %PCV (Lower limit: 15 %PCV). (See Table 6) |
| Limit of Blank (LoB) | LoB consistent with low-end measurement expectations. | iCa: LoB 0.119 mmol/L Hct: LoB 0 %PCV (See Table 7) |
| Limit of Detection (LoD) | LoD consistent with low-end measurement expectations. | iCa: LoD 0.125 mmol/L Hct: LoD 0.4 %PCV (See Table 7) |
| Analytical Specificity (Interference) | Interference properties demonstrate substantial equivalence to predicate, with known interferences identified. | Various substances tested. Identified interferences for iCa: Bromide (dose-response needed), Lactate (≥6 mmol/L), Leflunomide (≥0.345 mmol/L), Magnesium (≥3.5 mmol/L), Nithiodote (≥5.3 mmol/L), Teriflunomide (≥0.049 mmol/L), Thiocyanate (≥0.898 mmol/L). Identified interferences for Hct: Bromide (dose-response needed), Total Protein (≥9.5 g/dL). (See Table 8) |
| Method Comparison (iCa) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ N: 343 Slope: 1.02, Intercept: -0.02, r: 0.99 Bias at MDLs: -0.009 to 0.003 mmol/L (See Table 9) |
| Method Comparison (Hct) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ / Epoc Blood Analysis System N: 535 Slope: 1.000, Intercept: -1.00, r: 0.98 Bias at MDLs: -1.0 %PCV (See Table 10) |
| Method Comparison (Capillary Hct only) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence for capillary samples. | N: 208 Slope: 1.000, Intercept: 0.00, r: 0.97 Range: 18-73 %PCV Bias at MDLs (Native): 0.0 %PCV. (See Tables 11 & 12) |
| Matrix Equivalence (iCa) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 298 r: 0.99, Slope: 1.00, Intercept: 0.01 (See Table 13) |
| Matrix Equivalence (Hct) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 293 r: 0.99, Slope: 1.000, Intercept: 0.00 (See Table 13) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision (Aqueous Materials) - 20 Days: N=80-82 for iCa and Hct (number of measurements). Data provenance: Not specified, but likely internal lab data based on CLSI guidelines.
- Precision (Aqueous Materials) - Multi-site/Operator: N=90-97 for iCa and Hct (number of measurements). Data provenance: Three (3) sites, 2 operators per site. Not specified if within the US or international, or retrospective/prospective.
- Precision (Whole Blood): Sample sizes vary by analyte and range:
- iCa Venous: N=5-95
- iCa Arterial: N=0-92
- Hct Venous: N=7-88
- Hct Arterial: N=2-104
- Hct Capillary: N=17-109
- Data provenance: "collected across multiple point of care sites." Not specified if within the US or international, or retrospective/prospective, but implied prospective for the study as specimens were "collected with lithium heparin."
- Linearity/Assay Reportable Range: Sample not explicitly sized by patient count, but rather by varying analyte levels created from whole blood samples. Data provenance: Whole blood samples.
- Limit of Quantitation (LoQ): Whole blood samples (altered to low analyte level).
- Limit of Blank (LoB) & Detection (LoD): Whole blood samples (altered to blank/low levels).
- Analytical Specificity (Interference): Whole blood samples.
- Method Comparison:
- iCa Method Comparison: N=343 (pooled venous and arterial whole blood specimens).
- Hct Method Comparison (pooled): N=535 (venous, arterial, and capillary whole blood specimens).
- Hct Method Comparison (capillary only): N=208 (capillary whole blood specimens, native and contrived). N=193 for native only.
- Data provenance: "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites." "Capillary whole blood specimens collected from skin puncture... across multiple point of care sites." Implied prospective collection for the study. Not specified if within the US or international.
- Matrix Equivalence: N=298 for iCa, N=293 for Hct. Data provenance: "non-anticoagulated venous and arterial whole blood specimens." Implied prospective collection for the study.
3. 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)
This device is an in vitro diagnostic (IVD) instrument that provides quantitative measurements. The "ground truth" for these types of devices is established by a comparative method (often a laboratory reference method or another FDA-cleared device) rather than expert consensus on interpretations. The document explicitly mentions:
- iCa and Hct Method Comparison: The i-STAT CG8+ cartridge on the i-STAT 1 analyzer was compared against "a comparative method." For iCa, the predicate device i-STAT CHEM8+ was used as the comparative method. For Hct, the i-STAT CHEM8+ and Epoc Blood Analysis System were used as comparative methods.
- Traceability: iCa is traceable to NIST SRM956. Hct is traceable to CLSI H07-A3 procedure for determining packed cell volume by the microhematocrit method.
Therefore, no human experts were directly involved in establishing the ground truth for these quantitative measurements in terms of interpretation, as it's an analytical performance study against established analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or clinical findings and discrepancies need to be resolved. This study focuses on the analytical performance of a quantitative measurement device, where the ground truth is established by a "comparative method" or recognized reference standards, not by human interpretation requiring adjudication.
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
Not applicable. This is an analytical performance study for an IVD device, not a multi-reader multi-case clinical study involving human readers and AI assistance for interpretation. The device itself performs the measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire submission revolves around the standalone analytical performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. The "algorithm" (the device's internal measurement and calculation processes) generates quantitative results without human interpretation as part of its core function, although trained medical professionals operate the device. All the precision, linearity, detection limit, interference, and method comparison studies are evaluations of this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this quantitative measurement device is established through:
- Comparative Reference Methods: For method comparison studies, existing FDA-cleared or well-established laboratory methods (i-STAT CHEM8+ and Epoc Blood Analysis System) serve as the comparative ground truth.
- Certified Reference Materials/Standardized Procedures: Traceability to NIST SRM956 for iCa and CLSI H07-A3 for Hct indicates the use of recognized reference materials and standardized procedures for calibration and accuracy verification, which forms the basis for the ground truth in analytical measurements.
8. The sample size for the training set
The document does not explicitly describe a "training set" in the context of machine learning. This is an IVD device, and its development typically involves internal R&D, calibration, and verification rather than a dedicated machine learning "training set" as understood in AI/ML systems. All the presented studies are for validation of the finalized product.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" for a machine learning algorithm in the provided document, this question is not fully applicable. The development and internal validation of such a device generally rely on established metrological principles, using reference materials, spiked samples, and comparison to established methods to ensure accuracy and precision during its design and optimization phases.
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(269 days)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for ionized calcium (iCa). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.
The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.
The provided text is a 510(k) summary for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically for the ionized calcium (iCa) test. It details various performance characteristic studies to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text. Many elements cannot be fully answered as they are not explicitly stated in this specific document, which is a summary.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful outcomes of the performance studies. For a clearer table, we derive the 'acceptance criteria' from the observed 'performance' meeting regulatory expectations for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Aqueous Materials) | Low %CV values, indicating reproducibility across various levels and within/between runs/days. | iCa (mmol/L): - CV L1: Total CV 0.6% - CV L2/Control L1: Total CV 0.7% - CV L3/Control L2: Total CV 0.5% - CV L4/Control L3: Total CV 0.5% - CV L5: Total CV 1.5% |
| Precision (Whole Blood - Venous) | Low %CV values across different sample ranges. | Venous Whole Blood: - 0.25-0.75 mmol/L: 2.2% CV - 0.75-1.2 mmol/L: 1.6% CV - 1.2-1.5 mmol/L: 1.0% CV - 1.5-2.5 mmol/L: 0.9% CV |
| Precision (Whole Blood - Arterial) | Low %CV values across different sample ranges. | Arterial Whole Blood: - 0.25-0.75 mmol/L: 0.9% CV - 0.75-1.2 mmol/L: 3.0% CV - 1.2-1.5 mmol/L: 0.8% CV - 1.5-2.5 mmol/L: 0.5% CV |
| Linearity | Demonstrate linearity over the specified reportable range with a good fit. | Linearity demonstrated over 0.25 - 2.50 mmol/L reportable range. Regression: Slope 0.9738, Intercept 0.360, R2 0.999. "Absolute degree of nonlinearity results met the acceptance criteria." |
| Limit of Quantitation (LoQ) | LoQ should be at or below the lower limit of the reportable range. | LoQ determined to be 0.21 mmol/L, which is below the lower limit of the reportable range (0.25 mmol/L). |
| Limit of Blank (LoB) | LoB should be very low, indicating minimal signal in the absence of analyte. | LoB determined to be 0.14 mmol/L. |
| Limit of Detection (LoD) | LoD should be very low, indicating the lowest detectable concentration. | LoD determined to be 0.15 mmol/L. |
| Interference | No significant interference from common substances or specified interfering substances below allowed error (Ea). | Several substances tested; Interference identified for: Leflunomide, Lithium Lactate, Lithium Thiocyanate, Sodium Thiosulfate, Teriflunomide. For these, details on the specific effect (e.g., "Decreased results ≥ 0.4 mmol/L") are provided. Other substances showed no interference at tested concentrations. |
| Method Comparison with Predicate Device | Strong correlation (r value close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device. | iCa: N=250, Slope 1.00, Intercept -0.02, r 0.99. |
Study Details:
-
A table of acceptance criteria and the reported device performance: See table above.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Precision (Aqueous): 80-81 measurements per level (N values in Table 1). Data provenance is not specified regarding country, but it was conducted "at one site." The study design (20-day multi-day precision testing) implies a prospective collection of data for this specific study.
- Precision (Whole Blood): 241 samples (132 venous, 109 arterial). Data collected across "three point of care sites." Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned, but the context of a validation study typically implies prospective collection for this analysis.
- Linearity: Not explicitly stated but implies multiple whole blood samples across the range (0.22 - 2.81 mmol/L).
- LoQ/LoB/LoD: Not explicitly stated how many individual sample measurements were involved, but mentions "whole blood that was altered" and conducted over "four (4) days using two (2) cartridge lots."
- Interference: Not explicitly stated, but each substance was evaluated by comparing a control sample to a spiked sample.
- Method Comparison: 250 samples (N value in Table 6). Venous and arterial blood specimens were evaluated. Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned.
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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 for this type of device. This is an in vitro diagnostic (IVD) device for quantitative measurement. Ground truth is established by reference methods or direct measurement comparisons, not expert subjective interpretation (like radiologists for imaging). The predicate device (Epocal EPOC Blood Analysis System) served as the comparative method for the method comparison study.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring adjudication methods.
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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. This is not an AI-assisted diagnostic imaging device that involves human reader interpretation. It's an automated quantitative IVD system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The performance characteristics (precision, linearity, LoQ, LoD, LoB, interference) and the method comparison against a predicate device evaluate the device itself without direct human interpretation influencing the measurement result for iCa. The system automatically performs quality checks and suppresses results if specifications are not met.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For precision studies, the 'ground truth' is the mean value derived from repeated measurements of stable materials or samples, reflecting the inherent variability.
- For linearity studies, ground truth is established by accurately prepared samples with known concentrations.
- For LoQ/LoB/LoD studies, ground truth is based on samples expertly prepared to very low or zero analyte concentrations.
- For interference studies, ground truth is the expected value of the sample without the interfering substance.
- For method comparison, the predicate device (Epocal EPOC Blood Analysis System) serves as the "ground truth" or reference for comparison.
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The sample size for the training set:
- Not applicable. This document describes a traditional IVD device validation, not a machine learning or AI model development that requires a "training set" in the conventional sense of AI. The device's underlying technology relies on ion-selective electrodes, not a learned model from a large dataset.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
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(59 days)
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, Hematocrit, Ionized Calcium and Ionized Magnesium in heparinized venous whole blood, and pH. Ionized Calcium and Ionized Magnesium in plasma and serum.
Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety ofbone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
pH measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hematocrit measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
The Stat Profile Prime ES Comp Plus Analyzer is a small, low cost blood electrolyte analyzer. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The Stat Profile Prime ES Comp Plus Analyzer has an enhanced test menu and multiple quality control options. External Control Solutions (ampules) shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
The Stat Profile Prime ES Comp Plus Analyzer can accommodate either of two sensor cards in the sensor card housing. The analyzer will determine the test configuration of the system by detecting which sensor card is installed.
The two options for the sensor card are:
- Sensor Card 1 (Basic Electrolyte Panel plus Hct) shall enable and report the following listed analytes: Hct, Na, K, Cl
- Sensor Card 2(Full Electrolyte Panel plus pH & Hct) shall enable and report the following listed analytes: pH, Hct, Na, K, Cl, iCa, iMg
As with the predicates, the Stat Profile Prime ES Comp Plus Analyzer is microprocessor-based and incorporates ion selective electrode technology to measure pH, ionized calcium, ionized magnesium.
The Prime ES Comp Plus can be configured with an optional sample tray, which allows the user to run up to 10 consecutive samples may be any combination of Serum/Plasma or control solutions. Whole Blood samples may only be run in STAT Mode (not tray mode).
Calibration standards are provided in sealed pouches within a calibrator pack. Liquid quality control materials are available as external ampules. Sampling and calibration are fully automated.
The Stat Profile Prime ES Comp Plus Analyzer accepts lithium heparinized whole blood sample from syringes, open tubes, and small cups. The minimum sample sizes for analysis is 100 µL.
The provided text describes a 510(k) premarket notification for the "Stat Profile Prime ES Comp Plus Analyzer System," an in vitro diagnostic device for measuring various blood parameters. It does NOT describe an AI/ML-based device. Therefore, the requested information regarding AI/ML acceptance criteria, training/test sets, expert ground truth establishment, MRMC studies, etc., cannot be extracted from this document as it is not relevant to the described device.
The document focuses on demonstrating substantial equivalence to a predicate device (Nova Stat Profile pHOx Ultra Blood Gas Analyzer) through performance testing typically required for in vitro diagnostic devices, such as method comparison, precision, linearity, specificity/interference, detection limit, and shelf life stability.
Here's a breakdown of what can be extracted, addressing the closest relevant points, and explicitly stating what cannot be found:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria paired with the specific numerical reported device performance for each analyte (e.g., pH, iCa, iMg, Hct). Instead, it broadly states that "The results of the testing confirmed that the performance of the Stat Profile Prime ES Comp Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Blood Gas Analyzer (predicate device)." The study types performed are listed as:
- Method Comparison Studies
- Precision/Reproducibility Studies
- Run to Run Precision
- Linearity Testing
- Specificity / Interference Testing
- Detection Limit
- Shelf Life Stability Testing
Without the detailed test reports attached to this summary, the specific acceptance criteria thresholds and the measured performance values for each of these studies (e.g., specific bias ranges for method comparison, CV% limits for precision) are not available in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for each performance test (method comparison, precision, linearity, etc.).
- Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for intended use, implying laboratory-conducted studies. No information on country of origin or whether the data was retrospective or prospective is provided.
3. 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)
This question is not applicable. This device is an in vitro diagnostic analyzer, not an AI/ML system requiring human expert interpretation as ground truth for imaging or similar applications. The "ground truth" for the performance studies would be reference methods (for method comparison), known concentrations/values (for linearity/detection limit), or repeated measurements (for precision), all performed using established laboratory techniques, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a human interpretation study.
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
Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone analytical device, but the term "standalone performance" in the context of your prompt usually refers to the accuracy of an AI algorithm on its own. For this device, all performance listed (method comparison, precision, etc.) is its standalone performance. The device operates without human-in-the-loop interpretation assistance, but rather as an automated analyzer whose results are then used by healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference values for this type of device would typically be:
- For Method Comparison: Results obtained from a well-established, validated reference method or another legally marketed device known for its accuracy.
- For Linearity: Samples with precisely known concentrations prepared gravimetrically or volumetrically.
- For Precision/Reproducibility: Statistical analysis of repeated measurements on stable samples.
The document does not specify the exact reference instruments or methods used, but this is the general approach for IVD devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set." Its operating principles are based on ion-selective electrodes and impedance sensors, as described.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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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(10 days)
The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, SO2, Na', K', Cl' and Ca* in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
For Professional Use Only
For In Vitro Diagnostic Use
The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in. 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium and choride of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.
Here's a breakdown of the acceptance criteria and study information for the AVL OPTI Critical Care Analyzer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for precision, linearity, or interference. Instead, it describes compliance through comparative studies and general statements of no significant difference. Here's a summary of the reported performance:
| Parameter | Acceptance Criteria (explicitly stated) | Reported Device Performance |
|---|---|---|
| Precision | Not explicitly stated | "Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on two AVL OPTI instruments using samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution." (No specific numerical results provided) |
| Linearity | Not explicitly stated | "Wherever possible, linearity for the OPTI measurement has been established against reference materials or methods. Linearity for pH of whole blood is established by measurement of blood specimens which were tonometered to various CO2 values, and measured on an AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers, and on OPTI Critical Care Analyzers." (No specific numerical results provided) |
| Interferences | Not explicitly stated (implied compliance with guidelines) | "Representative samples taken the published guidelines for evaluation of interference substances and identified from literature were evaluated." (No specific numerical results or identified interferences provided) |
| Clinical Correlation | No significant difference (P<0.05) to predicate devices | "In all evaluations, there was no significant difference in mean values (P<0.05) obtained on measurement by the AVL OPTI from those of the predicate devices." |
| Safety and Effectiveness | Equivalent to predicate devices | "Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and non-clinical trials demonstrates that the AVL OPTI Critical Care Analyzer with the additional analytes: chloride and ionized calcium, is safe, effective, and equivalent to those predicate devices to which it is compared." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for the precision, linearity, interference, or clinical correlation tests. It mentions "samples: serum, reduced bovine hemoglobin solution and three levels of aqueous quality control solution" for precision and "remnant from patient specimens of both whole blood collected for routine analysis on existing instrumentation" for clinical tests.
- Data Provenance: The data appears to be prospective for the clinical tests, as it uses "remnant from patient specimens... collected for routine analysis." The country of origin is not explicitly stated, but given the submitter's address (Roswell, GA) and the FDA submission, it implicitly refers to studies conducted in the United States or under US regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth. For the clinical correlation study, the comparison was made against "predicate devices" operated by "personnel trained to perform and report these analyses." The AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers was used for linearity of pH as a reference method.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none). The clinical evaluation involved direct comparison to predicate devices, and the statistical analysis focused on the "mean values (P<0.05)."
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
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. The device is an automated critical care analyzer, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance evaluations of the AVL OPTI Critical Care Analyzer. It is an automated instrument that directly measures analytes, and the studies assess its precision, linearity, interference, and agreement with predicate devices without human interpretation as part of its core function.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance evaluations primarily involved:
- Reference Materials/Methods: For linearity, this included "reference materials or methods" and specifically an "AVL 995 pH/Blood Gas Analyzer standardized to N.I.S.T. traceable pH buffers."
- Predicate Devices: For clinical correlation, the ground truth was established by the measurements from "predicate devices" (e.g., NOVA Biomedical STAT 5, Chiron 865, AVL 995, etc.).
- Quality Control Solutions: For precision, "aqueous quality control solution" was used.
8. The Sample Size for the Training Set
The document does not mention any "training set" or "training data" in the context of machine learning or AI. This device is an automated analyzer based on optical fluorescence and reflectance, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or a machine learning component for this device, this question is not applicable.
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The AVL 9181 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
The AVL 9181 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results. The AVL 9181 is an improved design of our existing 9180 Electrolyte Analyzer [K961458] with the addition of an Autosampler to allow automatic sampling of up to 18 sample cups. The 9181 is exactly equivalent to the AVL 9180 with the exception of this single, additional feature. The manual needle mechanism of the 9180 was replaced with the automated needle mechanism from the AVL 988-4. The electronic circuitry to control the needle mechanism are incorporated into the 9180 display board. The sampler is taken from the 988-4 without modification except that the connector is changed to a smaller type. The 9180 main board already incorporated the controller for the sampler. The 9180 software was modified to add the automatic sampling feature. Calibration and measurement sequences are taken without alteration from the 9180 (sample volume, timing and algorithms). Once the sample probe is positioned in the sample cup, aspiration, measurement, wash and recalibration sequences are identical to the 9180.
Here's a breakdown of the acceptance criteria and study information for the AVL 9181 Electrolyte Analyzer, based on the provided text:
AVL 9181 Electrolyte Analyzer: Acceptance Criteria and Study Details
The provided document describes the AVL 9181 Electrolyte Analyzer as an improved design of the existing AVL 9180 Electrolyte Analyzer [K961458], with the primary addition of an Autosampler. The studies presented focus on demonstrating that this new feature, and the overall device, performs equivalently to the predicate devices and existing manual methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific thresholds for accuracy, precision, etc. Instead, it describes performance characteristics that were evaluated and concluded to be comparable to predicate devices and manual methods. The general acceptance criterion appears to be "no significant difference" (p < 0.05) in measurement values compared to predicate devices and between manual and automated modes.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | No significant difference (p < 0.05) in performance between 9181 (automated/manual) and AVL 9180. | Typical Within-Run (Swr), Between-Day (Sdd), and Total (ST) Precision determined. Tests performed in manual and automated modes. Conclusion: "no significant difference in performance exists between the 9181 in automated and manual measurement modes; and between the 9181 and its predecessor, the AVL 9180." |
| Linearity (N.I.S.T. SRM 956a) | Strong correlation (R-value close to 1) and low Sy*x. | Sodium: Slope 1.0134, Intercept -2.5307, Correlation Coefficient 0.99988, Syx 0.2709 Potassium: Slope 1.0133, Intercept -0.0230, Correlation Coefficient 0.99996, Syx 0.0166 Lithium: Slope 0.9717, Intercept 0.0482, Correlation Coefficient 0.99998, Sy*x 0.0067 (Note: This demonstrates linearity, but a direct comparison to an acceptance threshold isn't stated.) |
| Linearity (Serum) | Equivalent linearity to predicate methods; no significant difference (p < 0.05) between manual and automated modes. | All samples analyzed in pairs on two AVL 9181 instruments (Na/K/Cl, Na/K/iCa, Na/K/Li configurations) and compared to various predicate methods. Conclusion: "Linearity to measurement in serum compared to predicate methods evaluated is equivalent, and there is no significant difference in measurement results obtained in either mode of measurement (p < 0.05)." |
| Linearity (Urine) | No significant difference (p < 0.05) between methods evaluated (9181, 983, IL 943, Labconco) and between manual and automatic modes. | Analysis of random patient urine specimens on two AVL 9181 Electrolyte Analyzers (Na/K/Cl), two AVL 983 Na/K/Cl Electrolyte Analyzers (Na, K, Cl), a I.L. 943 Flame Photometer (Na, K), and a Labconco Digital Chloridometer (Cl). Conclusion: "No significant difference (p < 0.05) was found between any of the methods evaluated, or between manual and automatic modes of operation." |
| Clinical Correlation | No difference in mean values (P<0.05) between AVL 9181 and predicate devices (manual or automated modes). | Four field tests conducted comparing AVL 9181 to legally marketed predicate devices, in both manual and automated measurement modes. Specimens were remnant human whole blood and serum. Conclusion: "In all evaluations, there was no difference in mean values (P<0.05) obtained on measurement by the AVL 9181 and the predicate device in either manual or automated measurement mode." |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test: "2 runs per day with 2 replicates per run for 20 days on two model AVL 9181 analyzers" for each configuration and specimen type. This implies 80 individual measurements per configuration/specimen type (2 runs * 2 replicates * 20 days).
- Linearity in N.I.S.T. Standard Reference Material: The specific number of measurements or distinct samples is not given, but it utilized N.I.S.T. SRM 956a Electrolyte in Human Serum.
- Linearity in Serum: "All samples were analyzed in pairs on each of two of AVL 9181 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li." Also "in pairs on each of several instrument types" for comparison. The exact number of samples is not stated.
- Linearity in Urine: "analysis of random patient urine specimens" on the specified instruments. The exact number of samples is not stated.
- Clinical Tests: "Specimens analyzed in these tests were remnant from patient specimens of both whole blood and serum collected for routing analysis on existing instrumentation." The exact number of patient specimens is not stated.
Data Provenance:
- The N.I.S.T. SRM 956a is a certified reference material, likely of US origin.
- "Random patient urine specimens" and "remnant from patient specimens of both whole blood and serum" indicate retrospective clinical data.
- The locations of the "four field tests" are not specified, so the country of origin for the clinical data is not explicitly stated, but the submission is to the FDA, suggesting US-based or internationally recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by measurements from predicate devices (e.g., AVL 9180, IL Model 943 Flame Emission Photometer, Labconco Digital Chloridometer) and standard reference materials (N.I.S.T. SRM 956a). These are considered the 'gold standard' for the respective analytes. There were no human experts used to establish a "ground truth" in the interpretive sense (like reading an image). The accuracy of these measurements is inherent to the certified materials and established predicate devices.
The personnel operating the device for the clinical trials were "minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting," but they were performing analyses, not establishing a new ground truth.
4. Adjudication Method for the Test Set
No explicit adjudication method is described, as the ground truth was established by instrumental measurements and certified reference materials, not human interpretation requiring adjudication. Statistical analysis (e.g., p < 0.05) was used for comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an electrolyte analyzer, not an interpretive medical imaging or diagnostic device that would typically involve multiple human readers. The comparison was between automated device measurements and predicate device measurements.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The studies assessed the AVL 9181's performance (linearity, precision, and correlation) when operating on its own, both in manual and automated modes, against established methods and predicate devices. The "algorithm" here refers to the internal analytical processes and measurement taking place within the instrument.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Certified Reference Materials: Specifically N.I.S.T. SRM 956a Electrolyte in Human Serum for linearity studies.
- Measurements from Legally Marketed Predicate Devices: These instruments serve as the established "truth" against which the new device's measurements are compared. Examples include the AVL 9180, IL Model 943 Flame Emission Photometer, Labconco Digital Chloridometer, and AVL 983 Electrolyte Analyzers.
- Established Analytical Methods: The principles of measurement and calibration sequences are identical to predicate devices, implying that these established methods constitute the "truth" for how these analytes are measured.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of medical device (an in-vitro diagnostic analyzer) typically relies on engineering design and validation against known standards and predicate devices rather than "training" in the machine learning sense. The device's "training" for its algorithms would be the manufacturing calibration and software development process, which isn't described in terms of a "training set."
9. How the Ground Truth for the Training Set was Established
As there is no explicit "training set" described in the context of machine learning, the question of how its ground truth was established is not applicable. The device's operational parameters are based on established chemical and electrical principles for ion-selective electrodes, calibrated against standards and proven in predicate devices.
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The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions, or QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders and, as such, have come to be among those which are considered by the American Association of Clinical Chemistry to have the potential of being life threatening if left uncontrolled.
The AVL 9180 Electrolyte Analyzer is a microprocessor-based instrument using ionselective electrodes for the measurement of sodium, chloride, ionized calcium and lithium. The user is able to select any one of the measurement modes: whole blood, serum, urine, standard, OC material, acetate or bicarbonate dialysate, depending on the sample type to be analyzed. The analyzer automatically processes the sample through the necessary steps, then prints and displays the results.
In the blood, serum and QC measuring modes, the results for sodium and potassium are reported by default as flame photometry equivalent; chloride, ionized calcium and lithium are reported as ISE direct potentiometric values. The urine mode allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard modes allow for the measurement of aqueous standards and dialysate solutions and reports as ISE direct potentiometric values.
The provided text describes the AVL 9180 Electrolyte Analyzer, an ion-specific electrolyte analyzer for measuring sodium, potassium, chloride, ionized calcium, and lithium. The submission focuses on demonstrating the substantial equivalence and performance of the new device compared to existing predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text (e.g., "correlation coefficient > 0.95"). Instead, the document implies that the device meets acceptance criteria if its performance is comparable to predicate devices and falls within "manufacturers claims and expectations." The core of the performance evaluation relies on correlation coefficients, slopes, and intercepts from comparative studies, demonstrating the agreement between the AVL 9180 and established methods.
The tables presented in the document are the reported device performance. I will present a summary table outlining the key performance metrics from the various comparative studies, grouped by parameter and comparator.
| Parameter | Performance Metric (Type of Study) | Reported Value / Range | Indication of Acceptance |
|---|---|---|---|
| Sodium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99995 | Excellent linearity |
| Slope (Linearity) | 0.99993 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0128 | Close to ideal intercept of 0 | |
| Potassium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99919 | Excellent linearity |
| Slope (Linearity) | 0.99838 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0119 | Close to ideal intercept of 0 | |
| Chloride (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99994 | Excellent linearity |
| Slope (Linearity) | 0.97556 | Close to ideal slope of 1 | |
| Intercept (Linearity) | -0.1775 | Close to ideal intercept of 0 | |
| Ionized Calcium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99980 | Excellent linearity |
| Slope (Linearity) | 1.01552 | Close to ideal slope of 1 | |
| Intercept (Linearity) | -0.0078 | Close to ideal intercept of 0 | |
| Lithium (Aqueous Solutions) | Correlation Coefficient (Linearity) | 0.99985 | Excellent linearity |
| Slope (Linearity) | 0.99850 | Close to ideal slope of 1 | |
| Intercept (Linearity) | 0.0087 | Close to ideal intercept of 0 | |
| Sodium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9908 | Very good correlation |
| Slope | 0.9617 | Close to ideal slope of 1 | |
| Potassium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9991 | Excellent correlation |
| Slope | 1.0249 | Close to ideal slope of 1 | |
| Lithium (Serum vs. Flame Absorbance) | Correlation Coefficient | 0.9822 | Very good correlation |
| Slope | 0.9803 | Close to ideal slope of 1 | |
| Sodium (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9992 | Excellent correlation |
| Slope | 0.9895 | Close to ideal slope of 1 | |
| Potassium (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9996 | Excellent correlation |
| Slope | 1.0223 | Close to ideal slope of 1 | |
| Chloride (Serum vs. ISE Direct Potentiometry - AVL 983) | Correlation Coefficient | 0.9995 | Excellent correlation |
| Slope | 0.9631 | Close to ideal slope of 1 | |
| Ionized Calcium (Serum vs. ISE Direct Potentiometry - AVL 984) | Correlation Coefficient | 0.9960 | Excellent correlation |
| Slope | 0.8898 | Good correlation, slightly lower slope | |
| Lithium (Serum vs. ISE Direct Potentiometry - AVL 985) | Correlation Coefficient | 0.9985 | Excellent correlation |
| Slope | 0.9923 | Close to ideal slope of 1 | |
| Sodium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9856 | Very good correlation |
| Potassium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9994 | Excellent correlation |
| Chloride (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9989 | Excellent correlation |
| Ionized Calcium (Serum vs. Flame Correlation - AVL 9130, 9140) | Correlation Coefficient | 0.9954 | Excellent correlation |
| Sodium (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9973 | Excellent correlation |
| Slope | 1.0173 | Close to ideal slope of 1 | |
| Potassium (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9976 | Excellent correlation |
| Slope | 1.0312 | Close to ideal slope of 1 | |
| Chloride (Urine vs. direct ISE - AVL 983) | Correlation Coefficient | 0.9972 | Excellent correlation |
| Slope | 0.9817 | Close to ideal slope of 1 | |
| Sodium (Urine vs. Flame Absorbance - IL 943) | Correlation Coefficient | 0.9901 | Very good correlation |
| Slope | 0.9173 | Good correlation, slightly lower slope | |
| Potassium (Urine vs. Flame Absorbance - IL 943) | Correlation Coefficient | 0.9976 | Excellent correlation |
| Slope | 1.0312 | Close to ideal slope of 1 | |
| Chloride (Urine vs. Chloridometry - Labconco Digital) | Correlation Coefficient | 0.9972 | Excellent correlation |
| Slope | 0.9817 | Close to ideal slope of 1 | |
| Sodium (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9495 | Good correlation |
| Potassium (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9873 | Very good correlation |
| Chloride (Clinical vs. KODAK Ektachem XR700) | Correlation Coefficient | 0.9762 | Very good correlation |
| Clinical Field Tests (example data presented) | No difference in mean values | P < 0.05 | Meets statistical equivalence |
2. Sample Sizes Used for the Test Set and Data Provenance
- Aqueous Linearity Standards: 300 samples for Sodium, Potassium; 100 samples for Chloride, ionized Calcium, Lithium. Data provenance: Gravimetrically prepared from N.I.S.T. traceable salts (non-clinical, laboratory setting).
- Serum Linearity (vs. Flame Absorbance): 50 samples for Sodium, Potassium; 15 samples for Lithium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
- Serum Linearity (vs. ISE Direct Potentiometry - AVL 983, 984, 985): 50 samples for Sodium, Potassium, Chloride, ionized Calcium; 15 samples for Lithium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
- Serum Linearity (vs. ISE Direct Potentiometry with flame correlation - AVL 9130, 9140): 50 samples for Sodium, Potassium, Chloride, ionized Calcium. Data provenance: Commercially prepared serum linearity standards and random patient serum samples (non-clinical, likely laboratory setting).
- Urine Linearity (vs. direct ISE - AVL 983): 56 samples for Sodium, Potassium, Chloride. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
- Urine Linearity (vs. Flame Absorbance - IL 943): 56 samples for Sodium, Potassium. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
- Urine Linearity (vs. Chloridometry - Labconco Digital): 56 samples for Chloride. Data provenance: Random patient urine specimens (non-clinical, likely laboratory setting).
- Clinical Field Tests:
- Vs. KODAK Ektachem XR700: 103 samples for Sodium, Potassium, Chloride.
- Vs. other unspecified predicate devices: 102 samples for Sodium, Potassium, Chloride, ionized Calcium in one comparison; 102 samples for Sodium, Potassium, ionized Calcium in another; 104 samples for Lithium in another; 15 samples for Lithium in another comparison.
- Data provenance: "remnant from patient specimens collected for routine analysis on existing instrumentation" in a clinical setting. This indicates prospective or retrospective use of patient data from a clinical environment. The country of origin is not specified but presumably the USA, given the 510(k) submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test sets. The ground truth is established by the measurements from:
- N.I.S.T. traceable salts (for aqueous linearity).
- Predicate devices which are recognized and established methods (Flame Absorbance Emission Spectroscopy, existing AVL ISE analyzers, Labconco Digital Chloridometer, KODAK Ektachem XR700).
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The ground truth is established by the specified reference methods/predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an automated electrolyte analyzer, not an imaging device requiring human interpretation, so this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the AVL 9180 Electrolyte Analyzer. The device is a self-contained unit that performs measurements automatically ("The analyzer automatically processes the sample through the necessary steps"). The clinical field tests also state "operated by personnel trained to perform and report these analyses," indicating the device is used in a standalone manner with trained operators.
7. The Type of Ground Truth Used
The ground truth used for the studies is:
- Gravimetrically prepared N.I.S.T. traceable standards (for aqueous linearity).
- Measurements from legally marketed predicate devices (Flame Absorbance Emission Spectroscopy, existing AVL 983, AVL 984, AVL 985, AVL 9130, AVL 9140 Electrolyte Analyzers, IL 943 Flame Photometer, Labconco Digital Chloridometer, KODAK Ektachem XR700). These predicate devices represent established and accepted methods for electrolyte measurement, serving as the de facto "ground truth" for demonstrating equivalence.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning. The AVL 9180 is a microprocessor-based instrument using ion-selective electrodes, which relies on electrochemical principles rather than machine learning models that require distinct training and test sets. The "calibration" mentioned is an internal process for the instrument's electrodes and sensors, not a machine learning training phase.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" in the machine learning sense, this question is not applicable. However, for the instrument's calibration (which can be considered analogous to "training" in a broad sense for analytical instruments), the document mentions:
- "A 2-point calibration is performed automatically every 4 hours in READY mode, and a 1-point calibration is performed automatically with each measurement."
- "Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments..."
This implies that N.I.S.T. traceable salts and potentially internal calibration solutions are used to establish the "ground truth" for the device's internal calibration processes.
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