Search Results
Found 4 results
510(k) Data Aggregation
(36 days)
CARESIDE ANALYZER
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.
The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges. The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port. The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.
The provided text describes the CARESIDE™ Analyzer, an in vitro diagnostic instrument for measuring clinical chemistry analytes. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance (510(k)), rather than presenting a detailed study proving performance against explicit acceptance criteria.
However, based on the information provided, we can infer the approach taken for performance evaluation and how "acceptance criteria" are implied through comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in the format requested (e.g., "Accuracy must be within X% of reference method"). Instead, it relies on demonstrating substantial equivalence to an existing legally marketed predicate device (the Vitros DT 60/DTSC/DTE II Module and their own previously cleared CARESIDE Analyzer for lab use).
For each analyte the CARESIDE Analyzer measures, its performance would have been compared to the predicate device. The general "acceptance criteria" for regulatory clearance in this context are that the new device's performance is equivalent or better than the predicate device for its intended use, without raising new questions of safety or effectiveness.
While specific percentage differences or statistical thresholds are not given in this summary, the "Comparative Performance Characteristics" section states: "The clinical data provided demonstrate that the CARESIDE Analyzer... performs equivalently or better than the other legally marketed predicate device." This implies that for each analyte, the observed agreement, correlation, bias, and precision met the FDA's criteria for substantial equivalence when compared to existing devices.
To illustrate how such a table would be structured if explicit criteria were available, and how the performance statement translates, let's use a hypothetical example for a single analyte (e.g., Glucose) and infer the comparison:
| Acceptance Criteria Category | Specific Acceptance Criterion (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Implied from Summary) |
|---|---|---|
| Accuracy (Correlation) | Correlation coefficient (R) vs. Predicate Device ≥ 0.95 (Hypothetical) | "Equivalent or better" than Predicate Device |
| Accuracy (Bias) | Mean bias vs. Predicate Device ≤ X% (Hypothetical) | "Equivalent or better" than Predicate Device |
| Precision (CV%) | %CV ≤ Y% for specified concentration ranges (Hypothetical) | "Equivalent or better" than Predicate Device |
| Measurement Range | Analytical Measuring Range (AMR) similar to Predicate Device | Similar to Predicate Device |
| Interferences | No significant interference at physiological levels (Hypothetical) | Comparable to Predicate Device |
The document points out that details for each individual test's 510(k) submission would contain the specific performance data ("see individual test 510k submissions").
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "clinical data provided" without further detail. This information would typically be found in the specific validation studies submitted with each individual test cartridge's 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a clinical chemistry analyzer, the "ground truth" for the test set would typically be established by comparison to a recognized reference method or a predicate device, as opposed to expert consensus on images or clinical assessments. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not directly applicable in the same way it would be for, say, an AI-powered diagnostic imaging device.
For a clinical chemistry analyzer, consistency and agreement with a predicate device or a gold standard laboratory method are the primary measures of ground truth. The "experts" involved would be clinical chemists, laboratory scientists, or medical technologists who perform the reference measurements and analyze the results. Their qualifications would include relevant certifications and experience in clinical laboratory testing.
4. Adjudication Method for the Test Set
As the ground truth is established by quantitative comparison to reference methods or a predicate device, an "adjudication method" in the sense of a committee resolving disagreements (e.g., 2+1, 3+1) is not typically used for clinical chemistry results. The differences between the new device and the reference/predicate would be analyzed statistically to determine agreement, bias, and correlation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to evaluate the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, particularly in fields like radiology or pathology where human interpretation is central. The CARESIDE Analyzer is a standalone instrument that provides quantitative measurements, not an aid designed to improve human reader performance in interpreting complex data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the information provided describes the performance of the CARESIDE Analyzer as a standalone device. The instrument performs the measurement and calculation of results directly from the sample without human interpretation of raw signals. The comparison in the submission (as inferred) is between the measurements obtained by the CARESIDE Analyzer and those obtained by predicate devices or reference methods.
7. The Type of Ground Truth Used
The ground truth used for validating the CARESIDE Analyzer's performance would primarily be:
- Reference Methods: Measurements obtained from established, accurate laboratory methods (e.g., spectrophotometry, chromatography, highly accurate ion-selective electrodes) in a qualified clinical laboratory.
- Predicate Device Data: Performance data obtained from the legally marketed predicate device (Vitros DT 60/DTSC/DTE II Module and the CARESIDE Analyzer for lab use) on the same samples.
The document states that the individual test (analyte) cartridges were subject to separate 510(k) submissions, and those submissions would contain the detailed ground truth information for each specific analyte.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. The CARESIDE Analyzer is factory-calibrated, and lot-specific calibration coefficients are provided via barcodes on the cartridges. This implies that extensive calibration and characterization data (which could be considered a form of "training data" for the internal algorithms/calibration curves) were collected by the manufacturer during development and manufacturing. However, the exact sample sizes for this internal development and calibration are not disclosed in this regulatory summary.
9. How the Ground Truth for the Training Set was Established
The ground truth for establishing the factory calibration (which is analogous to the "training set" for the device's inherent algorithms) would typically involve:
- Certified Reference Materials (CRMs) or Standard Solutions: Samples with known, highly accurate concentrations of analytes.
- Split Sample Analysis: Running samples on both the CARESIDE system and established reference methods (or predicate devices) in a robust laboratory setting to generate the dose-response curves and calibration coefficients.
- Statistical Modeling: Using the data from CRMs and split samples to derive the polynomial equations that convert raw reflectance/potentiometry signals into analyte concentrations.
The document mentions that "The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve." This "master dose-response curve" and its associated polynomial are derived from this extensive calibration process using samples with established ground truth. This process ensures the instrument correctly interprets its raw signals into clinically meaningful concentrations across its analytical measuring range.
Ask a specific question about this device
(51 days)
CARESIDE ANALYZER
For in vitro diagnostic use with Exigent Diagnostics' CARESIDE™ Analyzer to measure total cholesterol from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with disorders of lipid and lipoprotein metabolism
CARESIDE™ Total Cholesterol cartridges are used with the Exigent Diagnostics CARESIDE™ Analyzer to measure total cholesterol concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Cholesterol cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total cholesterol concentration. The film cartridge (patent pending) contains all reagents necessary to measure total concentration of cholesterol.
The Exigent Diagnostics CARESIDE™ Total Cholesterol device is a quantitative in vitro diagnostic system for measuring total cholesterol in anti-coagulated whole blood, plasma, or serum specimens when used with the CARESIDE™ Analyzer. The device's performance was evaluated by comparing it to the legally marketed predicate device, Johnson and Johnson’s Vitros CHOL Slides for the Vitros DT 60 II. The study focused on accuracy, precision, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly defined in terms of specific performance targets (e.g., "accuracy must be >95%"). Instead, the document demonstrates substantial equivalence by presenting comparative performance characteristics against a predicate device. The implicit acceptance criterion is that the CARESIDE™ device performs as well as or better than the predicate device for key metrics.
| Performance Characteristic | Acceptance Criteria (Implicit: As good as or better than predicate) | CARESIDE™ Total Cholesterol Performance | Predicate Device (Vitros CHOL DT Slides) Performance |
|---|---|---|---|
| Detection Limit | 50 mg/dL | 50 mg/dL | 50 mg/dL |
| Reportable Range | At least 50 to 325 mg/dL | 50 to 450 mg/dL | 50 to 325 mg/dL |
| Accuracy | Not explicitly defined, but assumed to be acceptable | Mean recovery 106% | Not provided |
| Precision | Comparable to predicate (e.g., CV%) | Total CV, 203 mg/dL, 5.2% | Total CV, 202 mg/dL, 3.4% |
| Method Comparison | Strong correlation with predicate | CARESIDE™ = 1.04 (Vitros CHOL DT) + 23 mg/dL, r = 0.94 | Not provided |
| Linearity | Within acceptable limits | Linearity by mixing and by dilution yielded slope and correlation coefficient within acceptable limits | Not provided |
| Interference | No significant interference at specified concentrations | No significant interference observed at: | |
| Ascorbic acid 1 mg/dL | |||
| Bilirubin 10 mg/dL | |||
| Hemoglobin 250 mg/dL | |||
| Protein 5 to 9 g/dL | |||
| Triglyceride 600 mg/dL | Very high protein > 10 mg/dL |
The study concludes that the nonclinical and clinical data provided demonstrate that the CARESIDE™ Total Cholesterol product is as safe, effective, and performs as well as or better than the legally marketed predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the provided sections. Details regarding the number of patient samples (e.g., for accuracy, precision, or method comparison studies) are not given.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the context of a 510(k) summary for a diagnostic device seeking U.S. market clearance, it is highly probable that the studies were conducted in the U.S. or followed U.S. regulatory guidelines for clinical data. The studies would typically be prospective for clinical performance evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The Exigent Diagnostics CARESIDE™ Total Cholesterol is an in vitro diagnostic (IVD) device for quantitative measurement of a biochemical analyte (total cholesterol). The "ground truth" for measuring cholesterol concentration is established by a reference method (Abell Kendall in this case) and validated laboratory procedures, not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is based on quantitative chemical measurements against a reference method (Abell Kendall), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The CARESIDE™ device is an automated in vitro diagnostic test for measuring a chemical concentration; therefore, MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance presented for the CARESIDE™ device is standalone performance. The device automatically measures cholesterol concentration by processing the sample and uses its internal algorithm (based on reflectance measurements and a lot-specific standard curve) to calculate the total cholesterol concentration. The performance metrics (accuracy, precision, linearity, method comparison, interference) represent the device's capability to provide measurements independently of human interpretation of the final result, beyond the initial sample application and instrument operation.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation of the CARESIDE™ Total Cholesterol device typically relies on established reference methods and laboratory standards. Specifically, the document states:
- Reference Method: Abell Kendall. This method is a widely accepted and rigorous chemical method for determining cholesterol concentration and serves as the gold standard for accuracy comparisons.
- Comparative Method: Vitros CHOL DT Slides (predicate device), which itself is compared to and validated against established reference methods.
Therefore, the ground truth is primarily based on chemical reference methods/laboratory standards.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For an IVD device, the "training set" would typically refer to data used during the development and calibration of the device's algorithms and standard curves. This information is generally part of the internal development process and not always detailed in the 510(k) summary unless specific machine learning components require it for regulatory review, which is less common for enzymatic assays like this.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, based on typical IVD development, the ground truth for establishing calibration curves and optimizing the enzymatic reactions would involve:
- Known concentration standards: Using commercially available or internally prepared solutions with precisely known cholesterol concentrations.
- Reference laboratory measurements: Analyzing samples using established reference methods (like Abell Kendall or other highly accurate laboratory methods) to determine their true cholesterol levels, which are then used to develop and validate the device's calibration.
This process ensures that the device's measurements are accurate across its reportable range.
Ask a specific question about this device
(56 days)
CARESIDE ANALYZER
For in vitro diagnostic use with the CARESIDE™ Analyzer to quantitatively measure inorganic phosphorus from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
CARESIDE™ Phosphorus cartridges are used with the CARESIDE™ Analyzer to quantitatively measure phosphorus concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Phosphorus cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of phosphorus concentration. The film cartridge (patent pending) contains all reagents necessary to measure phosphorus concentration.
Here's an analysis of the acceptance criteria and study information for the CARESIDE™ Phosphorus device based on the provided text:
CARESIDE™ Phosphorus Device Performance Analysis
1. Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device rather than defining new, explicit numerical acceptance criteria for overall performance. Instead, the acceptance is demonstrated by showing comparable or better performance across various analytical characteristics.
| Acceptance Criteria Category | CARESIDE™ Phosphorus Reported Performance | Predicate Device (Vitros PHOS DT Slides) Reported Performance |
|---|---|---|
| Detection Limit | 0.5 mg/dL | 0.5 mg/dL |
| Reportable Range | 0.5 to 15 mg/dL | 0.5 to 13 mg/dL |
| Accuracy | Mean recovery 97% | Not provided |
| Precision | Total CV, 3.5 mg/dL, 4.0% | Total CV, 4.9 mg/dL, 3.7% |
| Method Comparison | CARESIDE™ = 0.99 (Vitros PHOS DT) + 0.49, r = 1.00 (against Vitros PHOS DT) | (Implicitly, this is the reference) |
| Linearity | Linearity by mixing and by dilution yielded slope and correlation coefficients within acceptable limits. | Not provided |
| Interference | No significant interference observed at tested concentrations of: Ascorbic Acid (10 mg/dL), Bilirubin (20 mg/dL), Hemoglobin (100 mg/dL), d-Mannitol (800 mg/dL), Triglycerides (1500 mg/dL) | Not provided |
| Specimen Types | No clinically significant difference between sodium heparinized whole blood, serum, sodium heparin plasma, and EDTA plasma. | No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable. |
| Expected Values | 2.2 to 4.4 mg/dL (Central 95%) | 2.5 to 4.5 mg/dL (Central 95%) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the various performance characteristic tests (e.g., accuracy, precision, method comparison, linearity, interference). It only lists the results.
The data provenance (country of origin, retrospective/prospective) is not specified. However, the context of a 510(k) submission to the US FDA implies that the studies were conducted to support US market approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This device is an in vitro diagnostic (IVD) for quantitative measurement of a biochemical analyte (phosphorus). The "ground truth" for such devices is typically established through:
- Reference methods (e.g., Phosphomolybdate Reduced method mentioned in the document).
- Certified reference materials or calibrators.
- Comparison to a legally marketed predicate device, which itself would have been validated against established analytical principles and reference methods.
The document does not mention the use of human experts or their qualifications for establishing ground truth for individual test cases, as this is not typically relevant for the analytical validation of a chemical assay. The "experts" in this context are implicitly the developers and clinical chemists who ensured the assay's analytical accuracy.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as imaging diagnostics where expert readers review cases and reach a consensus. For a quantitative chemical analyzer like the CARESIDE™ Phosphorus, this type of adjudication is not applicable. The device provides a numerical result, which is then compared against established analytical standards or reference methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic tools that involve human interpretation (e.g., radiology AI), assessing how AI assistance impacts human reader performance. The CARESIDE™ Phosphorus device is an automated chemical analyzer, not an AI-assisted diagnostic interpretation tool.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. All the reported performance characteristics (detection limit, reportable range, accuracy, precision, method comparison, linearity, interference, specimen types) represent the performance of the CARESIDE™ Phosphorus device and its integrated analyzer without human-in-the-loop interpretation. The device itself performs the measurement and calculation, making its reported performance inherently "standalone." The comparison to the predicate device essentially assesses its standalone performance against another standalone device.
7. Type of Ground Truth Used
The ground truth for this device's performance was established through:
- Reference Method Comparison: The "Reference Method" listed for both the CARESIDE™ Phosphorus and the predicate is "Phosphomolybdate Reduced," indicating that this established analytical method would have been used as a benchmark for comparison.
- Analytical Standards/Calibrators: The document mentions "lot-specific standard curve to calculate phosphorus concentration" and "Run Vitros DT II calibrators," implying the use of traceable standards and calibrators for accurate quantitative measurement.
- Predicate Device Comparison: A significant part of the safety and effectiveness claim is based on its performance in comparison to the legally marketed Vitros PHOS DT Slides. The predicate device's results would serve as a 'clinical ground truth' for the comparative effectiveness.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For an IVD device like this, the development process typically involves:
- Method Development & Optimization: Using various samples (unknown quantity) to refine reagents, reaction conditions, and instrument parameters.
- Calibration: Using a set of samples with known concentrations to establish the relationship between the measured signal and the analyte concentration. The device uses "lot-specific standard curve" and mentions "Calibration information bar-coded on each cartridge." This implies a calibration process, which could be considered analogous to training in an AI context, but isn't typically referred to as a "training set" with specific sample numbers in IVD submissions unless it's a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" as understood in machine learning is not explicitly detailed. However, the "ground truth" for the calibration and development of the device would have been established through:
- Reference Methods: Using the Phosphomolybdate Reduced method or other highly accurate, established laboratory techniques to determine the true phosphorus concentration in samples used for calibration curve generation and method development.
- Certified Reference Materials: Utilizing commercially available reference materials with precisely known phosphorus concentrations.
Ask a specific question about this device
(59 days)
CARESIDE ANALYZER
This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood.
This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.
The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include: CareSide™ Analyzer and Analyte-specific Cartridge(s).
The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, and incubates the specimen before reading the signal and calculating results. The CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.
The provided text describes a 510(k) summary for the Exigent Diagnostics CareSide™ Analyzer, submitted on February 23, 1998. It details the device's characteristics and compares its performance to a predicate device, the Vitros DT 60 II System, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, Vitros DT 60 II System, aiming for "as safe, effective, and performs as well as or better than" the predicate. The performance characteristics evaluated are Precision, Relative Accuracy, Linearity, Interference, and Detection Limit.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported CareSide™ Performance |
|---|---|---|
| Precision | Typical total CV 1.5% to 5.2% (for 4 tests evaluated by predicate) | Typical total CV 3.1% to 8.5% (for 4 tests evaluated) |
| Relative Accuracy | Not explicitly stated for predicate; implied to be acceptable for predicate | Mean difference [Vitros - CareSide™] from method comparison means is test specific (3% for 4 tests evaluated) |
| Linearity | Not provided for predicate; implied to be acceptable for predicate | Correlation coefficient >= 0.95 |
| Interference | Not provided for predicate; implied to be acceptable for predicate | Susceptibility to interference is test specific. |
| Detection Limit | Not provided for predicate; implied to be acceptable for predicate | Test specific. |
Note: The phrasing "as safe, effective, and performs as well as or better than the legally marketed predicate device" suggests that matching or improving upon the predicate's performance is the acceptance criterion. However, for "Precision," the CareSide™'s reported CV range (3.1% to 8.5%) is wider than the predicate's (1.5% to 5.2%), which might indicate worse precision. The submission, nonetheless, concludes that the data "demonstrate that the CareSide™ Analyzer is as safe, effective, and performs as well as or better than" the predicate, implying the FDA accepted these differences as not impacting substantial equivalence for the intended use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the comparative performance studies (Precision, Relative Accuracy, Linearity, Interference, Detection Limit). It mentions "4 tests evaluated" for Precision and Relative Accuracy, but this refers to the number of different types of chemical analytes for which performance was assessed, not the number of samples used for each evaluative test.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. Given that this is a clinical chemistry analyzer, the "ground truth" would typically come from a reference method run by a certified clinical laboratory, rather than expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of device (a micro chemistry analyzer) does not typically involve expert adjudication in the way, for example, a diagnostic imaging device might. Its performance is measured against reference methods, not subjective expert opinion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. MRMC studies are typically relevant for diagnostic devices where human interpretation is a key component, such as radiology or pathology imaging, to assess how AI assistance impacts human reader performance. This device is an automated analyzer, so such a study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the data presented ("Comparative Performance Characteristics") are for the standalone performance of the CareSide™ Analyzer. The device is described as "semi-automated" requiring only operator intervention for specimen addition and cartridge insertion, with the analyzer then automatically performing all steps and calculating results. The performance metrics (Precision, Accuracy, Linearity) reflect the algorithm's direct output compared to standard methods.
7. The Type of Ground Truth Used
The ground truth for assessing the CareSide™ Analyzer's performance implicitly comes from comparison to a legally marketed predicate device (Vitros DT 60 II System) and established laboratory reference methods.
- For Relative Accuracy, the comparison is directly stated: "Mean difference [Vitros - CareSide™]". This implies the Vitros results are considered a form of "ground truth" or a highly correlated reference.
- For Precision, this is measured inherently by repeated tests on the same sample, with the expectation that results should be tightly clustered.
- For Linearity and Detection Limit, these would be established by testing samples with known, varied concentrations or concentrations near the expected limit, using reference methods to determine the true values.
Therefore, the ground truth is based on established reference laboratory methods and comparison to a predicate device's performance.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This submission is for a device based on established chemical principles and reflectance photometry, not a machine learning or AI algorithm that would typically require a distinct training set in the modern sense. The "master dose-response curve" used for calculation is likely derived from validation studies during the device's development, but specific details on the dataset used for this are not given.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a separate "training set" in the context of modern AI/ML development isn't explicitly described for this device. The "master dose-response curve" and "lot-specific coefficients" are central to the analyzer's calculations. These would have been established during the development and manufacturing process using samples with known analyte concentrations, validated through standard laboratory reference methods, to ensure accurate quantification of reflectance to concentration. However, the exact methodology and ground truth establishment for these internal calibration curves are not detailed in this 510(k) summary.
Ask a specific question about this device
Page 1 of 1